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Wellbeing subsidiary KGK Science and the International Probiotics Association (“IPA”) applauds FDA’s Commitment to Release NDI Draft Guidance Documents in the Near Future

Wellbeing subsidiary KGK Science and the International Probiotics Association (“IPA”) applauds FDA’s Commitment to Release NDI Draft Guidance Documents in the Near Future

IPA to request a Probiotic FDA Town Hall

Vancouver, British Columbia, June 9, 2022 / Globe Newswire / – Wellbeing Digital Sciences Inc.  (“Wellbeing”or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), subsidiary KGK Science Inc. applauds the efforts on the part of U.S Food and Drug Administration (“FDA” or the “Agency”) to release the recent New Dietary Ingredient (“NDI”) enforcement draft guidance, which is part one of a multipart series of NDI guidance documents the FDA announced during a round table discussion at the IPA World Congress + Probiota Americas.

According to FDA, the recent enforcement discretion guidance on late submissions of NDI notifications, released on May 19, 2022, was in response to its commitment in the Fall of 2021 to update guidelines in 2022. Instead of releasing a single guidance document containing all issues for stakeholder notice and comment for a third time, FDA plans to release separate and smaller draft guidance with FDA’s thinking on each group of NDI topics.

IPA in conjunction with their U.S. Task Force Leader, Dr. Corey J. Hilmas, Chief Scientific Affairs and Regulatory Officer at KGK Science Inc., has initiated discussions with industry leaders to formally request a public meeting with the FDA to discuss issues that directly apply to probiotics. “Future draft guidance documents from the Agency on NDIs are critical to the probiotic industry and many of our KGK Science clients,” said Najla Guthrie, CEO of Wellbeing Digital Sciences.

“IPA has maintained a dialog with the Agency over the course of the prior two NDI draft guidance, and we anticipate many issues will remain unresolved in upcoming NDI guidance documents. Our issues and concerns are unique to probiotics, as we have stated in previous stakeholder comments, and IPA’s request for a formal probiotic public meeting is intended to ensure that FDA has all the information it needs to address these complex topics,” said George Paraskevakos, Executive Director of IPA.

“We believe a focused public meeting to address ongoing, unresolved issues related to probiotic NDIs, GMPs, labeling, and a host of other topics is long overdue. A public meeting would be a mutually beneficial process and dialog to have between the probiotic industry and the Agency over lingering issues that could not be resolved in any other format” stated Dr. Corey J. Hilmas, KGK’s Chief Scientific Affairs and Regulatory Officer.

“IPA looks forward to continuing our dialog with the various heads of FDA responsible oversight of probiotics in a more formal setting in College Park, Maryland,” said Solange Henoud, VP Regulatory and Compliance at Lallemand Health Solutions and Chair of IPA Regulatory Committee.

For more information on the FDA Release Draft Guidance on NDI Enforcement Discretion please visit the U.S. Food & Drug Administration page

ABOUT KGK SCIENCE  

Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points.  For additional information, please visit kgkscience.com.

ABOUT WELLBEING DIGITAL SCIENCES

Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.

ABOUT INTERNATIONAL PROBIOTICS ASSOCIATION

The International Probiotics Association (IPA) is a global non-profit organization bringing together through its membership, the probiotic sector’s stakeholders including but not limited to academia, scientists, health care professionals, consumers, industry and regulators. The IPA’s mission is promoting the safe and efficacious use of probiotics throughout the world. Holding NGO status before Codex Alimentarius, the IPA is also recognized as the unified “Global Voice of Probiotics®” around the world. To learn more about IPA, visit https://internationalprobiotics.org/.

On behalf of:  

Najla Guthrie

Chief Executive Officer  

WELLBEING DIGITAL SCIENCES

For further information, please contact:  

Natalie Dolphin

VP of Marketing & Investment Relations  

Email: ir@wellbeingdigital.co  

Twitter: @Wellbeing_IR  

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts.  Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.  

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

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Lobe Sciences Ltd Announces Change in Record Date of Share Consolidation

Lobe Sciences Ltd Announces Change in Record Date of Share Consolidation

Vancouver, British Columbia–(Newsfile Corp. – June 9, 2022) – Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) (“Lobe” or the “Company”) announces that further to the Company’s June 6, 2022, news release, the record date for the six for one consolidation has been adjusted to June 10, 2022.

The Canadian Securities Exchange has published a bulletin confirming that trading will remain halted June 9, 2022, and resume trading on a consolidated basis on Friday, June 10.

About Lobe Sciences Ltd.

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

For further information please contact:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

This does not constitute an offer to sell or a solicitation of offers to buy any securities.

Disclaimer for Forward Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact included in this release, including statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment;, that the Company’s drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company’s corporate goals and objectives; and other risk factors detailed in the Company’s continuous disclosure filings from time to time, as available under the Company’s profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

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Cybin Receives Institutional Review Board Approval for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

Cybin Receives Institutional Review Board Approval for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Treatment of Major Depressive Disorder

06/09/2022

— First-in-human Phase 1/2a trial evaluating the proprietary deuterated psilocybin analog CYB003 expected to begin in mid-2022 —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that it has received Institutional Review Board (“IRB”) approval to begin the first-in-human Phase 1/2a clinical trial evaluating CYB003, its proprietary deuterated psilocybin analog, for the treatment of major depressive disorder (“MDD”).

“IRB approval of our trial protocol is a significant regulatory milestone for CYB003 as it leads us one step closer to potentially providing this important treatment option to people in need. The team has worked tirelessly to move this program into the clinic, and we look forward to initiating the study in mid-2022 and further supporting our mission to develop psychedelics into therapeutics,” said Doug Drysdale, Chief Executive Officer of Cybin.

In May 2022, the Company announced that it had submitted an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for the Phase 1/2a clinical trial. Cybin IRL Limited, a wholly owned subsidiary of Cybin, has engaged Clinilabs Drug Development Corporation, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Phase 1/2a clinical trial of CYB003.

About the CYB003 Phase 1/2a Trial

The Phase 1/2a trial is a randomized, double blind, placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after single dose) and at Week 6 (after receiving a second dose). Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the benefit of more than one administration and will provide pharmacokinetic and safety data. The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (SSRIs). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of durability of treatment effects.

The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

About CYB003

CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder and alcohol use disorder.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

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Developing psychedelic treatments for ADHD and social anxiety

Filament Health and Jaguar Health Sign Letter of Intent to Develop Botanical Prescription Drugs for Specific Mental Health Indications

Filament Health (FH) announced several exciting updates this week.

First, the company shared that it has successfully developed a pharmaceutical-grade ayahuasca extract that can be administered in a capsule.

Filament also announced that it cultivated its 70th variety of psilocybin mushrooms and is conducting research to determine the most potent and effective variety.

Additionally, the Vancouver-based company is partnering with Jaguar Health to develop natural psychedelic medicines for neurodegenerative diseases, addiction, and mental health disorders. The partners are currently identifying plant candidates to treat ADHD and social anxiety disorder.

PDF of article 1

PDF of article 2

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Enveric Biosciences to Participate in Upcoming Conferences in June 2022

Enveric Biosciences to Participate in Upcoming Conferences in June 2022

NAPLES, Fla., June 8, 2022 /CNW/ – Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, today announced that Dr. Joseph Tucker, Chief Executive Officer of Enveric, will participate in three upcoming conferences:

A.G.P.’s Summer Healthcare Conference
Date: June 21st – 22nd, 2022
Location: Virtual

Gravitas’ 3rd Los Angeles Summit
Date: Wednesday, June 22nd at 1:30 p.m. PT
Location: Beverly Hills Hotel in Los Angeles, CA

H.C. Wainwright 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and Beyond
Date: Monday, June 27th, 2022 at 3:30 p.m. ET
Location: Lotte New York Palace Hotel
To attend, please register here.

For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate representatives, or send an email to A.G.P. at agpevents@allianceg.com, Gravitas at events@gravitassecurities.com, H.C. Wainwright at lk@hcwco.com or KCSA Strategic Communications at EnvericBio@kcsa.com.

About Enveric Biosciences
Enveric Biosciences, Inc. (NASDAQ: ENVB) is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For additional information, please visit www.enveric.com.

Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,”” expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of the company to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Cision View original content:https://www.prnewswire.com/news-releases/enveric-biosciences-to-participate-in-upcoming-conferences-in-june-2022-301563603.html

SOURCE Enveric Biosciences

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Optimi Health Finalizes Partnership and Psilocybin Supply Agreement With ATMA Journey Centers

Optimi Health Finalizes Partnership and Psilocybin Supply Agreement With ATMA Journey Centers

Strategic partnership will focus on improving regulatory outcomes in therapist training and safe supply of psilocybin

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, is pleased to announce that it has entered into an exploratory supply agreement with ATMA Journey Centers (“ATMA”), a privately held facilitator of psilocybin-assisted therapy and practitioner training services for palliative care and mental health conditions based in Calgary, Alberta.

The Company has finalized an agreement which will supply psilocybin products to ATMA for future therapist initiatives and supply requirements.

“Few organizations have made as significant a contribution in recent years to the evolving regulatory conversation around psilocybin-assisted therapy as ATMA Journey Centers,” said Bill Ciprick, CEO of Optimi Health. “Optimi is deeply gratified to be able to provide them with this test supply of natural psilocybin in order to facilitate research that may lead to better mental health services for healthcare workers while testing the potential to expand the scale of available psilocybin therapies.”

Optimi Health is looking forward to opportunities presented by this partnership with ATMA to advance the knowledge base of trained psychedelic therapists by providing learning experiences and real-world data derived from the direct administration of a natural psilocybin product.

Further, the Company views this and other early-phase trials and supply agreements as an opportunity to refine approaches and improve efficiencies around the commercial distribution and clinical applications of psilocybin in anticipation of more robust demand as clinical research improves regulatory outcomes for psychedelic medicine.

“The ability to conduct both experiential training for authorized therapists and the clinical trials that will allow us to provide these treatments to patients in need is dependent on a safe and consistent supply of high-grade psilocybin,” said David Harder, Co-CEO of ATMA Journey Centers. “This agreement is an important step toward ATMA’s goal of building a complete research and training infrastructure that will streamline further growth in these directions.”

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

ABOUT ATMA JOURNEY CENTERS

ATMA is pioneering a therapist-centered and therapist-driven business model for the psychedelic industry, by building the largest online community platform for psychedelic practitioners. Education, training, and business support services will all be accessible on one user friendly technology platform. ATMA’s philosophy of inclusivity will encourage more participation from healthcare professionals, which will in turn yield more data and experiences. Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, ATMA will be able to expand to other psychedelics as the regulatory environment also expands. ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

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Wesana Health CEO Daniel Carcillo to Keynote Charles River Symposium: Re-Imagining Substance Abuse, Addiction, and Mental Health Disorders with Psychedelic Therapies

Wesana Health CEO Daniel Carcillo to Keynote Charles River Symposium: Re-Imagining Substance Abuse, Addiction, and Mental Health Disorders with Psychedelic Therapies

His talk will kick-off the daylong biotechnology conference on cutting-edge therapies

CHICAGO and TORONTO, June 08, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pleased to confirm CEO Daniel Carcillo will be keynoting the upcoming Charles River Symposium, “Re-imagining Substance Abuse, Addiction, and Mental Health Disorders with Psychedelic Therapies.”

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe, accelerate their research and drug development efforts.

Mr. Carcillo’s keynote, “From Advocate to Executive: How my patient experience influences my work as CEO,” will cover his personal experience with psychedelic treatments and the inspiration that led him to found and lead Wesana. He will explore how he transformed himself from patient to advocate, to an inspiring leader.

  • Mr. Carcillo’s talk will begin at 9:10AM Pacific time on Thursday, June 9, 2022
  • Immediately following his keynote, Mateusz Dudek, PhD of Charles River will present “Reverse Engineering Discovery: A Collaborative Pathway to Preclinical Assessment of Daniel Carcillo’s Experience”

Event Overview

The mental health epidemic, including substance use and addiction, is a global issue. The crises began long before the COVID-19 pandemic, but two years of work? loss, stress, isolation, and treatment disruption has only exacerbated the number of people struggling with their mental health. Innovations in the range of medicines currently used in conjunction with psychotherapy have had little to no progress over the last two decades. The use of psychedelic therapy has changed this paradigm. With increased preclinical research and clinical trials illustrating the beneficial effects of first-generation psychedelics, a wave of second-generation therapeutics is now emerging. This event will highlight progress in both areas of translational research and provide a panel discussion on the trials and tribulations of developing these therapies for commercialization. To attend this hybrid event virtually or in person, visit: https://bit.ly/3tZuibl

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

Investor Relations:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 702-329-8038

Media Contacts:
Isadora Forman
Email: media@wesanahealth.com  
Phone: 917-653-4613

Primary Logo

Source: Wesana Health

Released June 8, 2022

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XPhyto adds pharmaceutical manufacturing expert Dr. Florian A. Sahr to its European team

XPhyto adds pharmaceutical manufacturing expert Dr. Florian A. Sahr to its European team

Vancouver, Canada, and Uttenweiler, Germany (June 8, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to report that Dr. Florian A. Sahr has joined its European operations as Head of Project Management. Dr. Sahr is a German-born and internationally trained leader in drug formulation, technology transfer and new-product manufacturing.

Dr. Sahr has a strong track record of drug development, including transdermal (“TDS”) and oral dissolvable (“ODF”) delivery systems, as well as the physical and regulatory establishment of GMP and FDA compliant pharmaceutical manufacturing facilities. Several employment highlights include his work as Senior Scientist, Head of Manufacturing, Gen-Plus GmbH & Co. KG, Munich, Germany, where he developed TDS and ODF drug formulations and transferred these new formulations and technologies to manufacturing systems and facilities; and his work as Project Manager, Advanced Projects, tesa Labtec GmbH, Langenfeld, Germany, focusing on project management and technology transfer of generic TDS formulations to the company’s manufacturing facilities. Dr. Sahr has held the regulated position of Head of Manufacturing according to AMG/AMWHV (German Medicines Act) for the production of clinical trial materials for a number of companies.

Dr. Sahr is engaged full-time with Vektor Pharma TF GmbH (“Vektor”), XPhyto’s wholly owned German subsidiary. Dr Sahr’s management of Vektor’s TDS and ODF product development programs, and his technology transfer skills are highly relevant as XPhyto reviews its ODF novel biosensor manufacturing options and opportunities.

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First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

First Patient Dosed in Second Phase 2 Add-on Ketamine Trial in Treatment-resistant Depression (TRD)

Dosing has commenced in HMNC Brain Health and Develco Pharma’s Phase 2 oral prolonged-release Ketamine (KET01) Study

The trial will assess the efficacy, safety, and tolerability of add-on treatment with KET01 in 117 patients suffering from Treatment-Resistant Depression (TRD)

Munich, June 8, 2022 – HMNC Brain Health (“HMNC” or the “company”), together with Develco pharma, today announced the dosing of the first patient in their second Phase 2 trial with oral prolonged-release Ketamine (KET01) for Treatment-Resistant Depression.

HMNC is a global precision psychiatry biopharma company, pioneering the development of personalized therapies powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects has partnered with Develco pharma, a company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs, in this trial.

The trial will assess the efficacy, safety, and tolerability of add-on treatment with Ketamine hydrochloride prolonged-release tablets (KET01) in patients suffering from Treatment-Resistant depression (TRD). It will enroll 117 TRD patients at approximately 38 clinical sites. The study’s selection criteria for patients to be included was defined by non-response to a minimum of two standard antidepressants in their current major depressive episode. The trial is expected to confirm the results of the previous trial, with early-onset of efficacy, showing placebo-level dissociative side effects, and excellent tolerability, furthering the take-at-home potential of this novel treatment.

“Our first investigator-initiated Phase 2 Proof of concept trial, which we announced the preliminary results for at end of March, suggested a positive trend in efficacy for KET01, which appears to be a safe and well-tolerated antidepressant with substantially limited dissociative side effects,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health.

The Ketabon program, which is a joint venture between HMNC Brain Health and Swiss-based Develco Pharma, funded the trial. Patients will be randomized into three treatment groups and will either receive a placebo, KET01 120 mg, or KET01 240 mg once daily (OD), in addition to their ongoing standard antidepressant treatment over a period of three weeks. The primary endpoint is the change on the established Montgomery–Åsberg Depression Rating Scale (MADRS) for depressive severity at day 21 compared to placebo.

HMNC Brain Health CEO Benedikt von Braunmühl added: “We are very pleased to have achieved this important milestone in the development of KET01 for Treatment-Resistant Depression. We believe KET01 has the potential to improve the lives of patients who are not responding to standard antidepressant therapies, and we are looking forward to further develop this potential medication with the insights generated from this trial”.

Topline data from the study is expected to be reported in the second quarter of 2023.

ABOUT HMNC BRAIN HEALTH

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its nascent AI platform and predictive companion diagnostics suite, leading to far shorter treatment durations, higher remission rates, and low side effects. The company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. HMNC Brain Health now enters the next stage of its development with a large-scale licensing and fundraising agenda.

ABOUT DEVELCO PHARMA

With headquarters in Pratteln/ Switzerland, Develco Pharma is a Swiss-German pharmaceutical company specializing in the development and manufacture of orally administered modified, prolonged & chrono release drugs containing known active ingredients. Established in 2006, today the company has a workforce of 130 employees. In Germany, a state-of-the-art production facility for analgesics & other indications has been in operation in Schopfheim, in the Baden region, since 2016. Develco identifies and defines pharmaceutical products containing known active ingredients and develops generic, hybrid, value added and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. On the strength of its experience and innovativeness, the company has emerged as an internationally recognized provider of pharmaceuticals for the treatment of several disease areas. The customer base of Develco Pharma includes global pharmaceuticals groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle- East, South Africa, Asia,andAustralia.

ABOUT THE KETABON PROGRAM

The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma in Switzerland, comprises an oral prolonged-release formulation of ketamine for TRD with minimal dissociative side effects. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects compared to the currently applied intravenous and intranasal ketamine therapies. TRD patients with insufficient response to standard antidepressants represent 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. In this group, prolonged-release ketamine has shown high response rates. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications, such as anxiety, aggression, PTSD, and panic disorder.

Media contacts

Alexander Schmidt (Europe)
+49 151 22 99 39 765
alexander.schmidt@gaulyadvisors.com

Anne Donohoe (U.S.)
+1 212-896-1265
hmnc@kcsa.com

Investor Contact (U.S.)

Sophia Bashford
+1 929 246 7307
sbashford@kcsa.com

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One year of psychedelic news

Today marks 1 year since the Daily Mushroom started!

In honour of our birthday, we’re bringing back our most popular content from the past year.

These were the articles that readers clicked on the most: 

  1. Can weed make your trip better?
  2. Toad venom for Grandma
  3. Psilocybin for gut health
  4. A dose every six months keeps the divorce lawyer away
  5. How psychedelics change your social life
  6. Mushrooms go high fashion
  7. You no longer have to be on your deathbed to eat mushrooms!
  8. Is Elon going to take shrooms to the moon?
  9. Take a DMT trip without the anxiety
  10. Healing racial trauma

And these were the most popular podcast episodes:

  1. A doctor’s view on group psychedelic therapy & microdosing
  2. The truth about psilocybin and the brain
  3. What physicians really think about psilocybin
  4. A special episode: Our host Brett recounts a recent psilocybin therapy session
  5. Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

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