Wesana Health (WESA) may expand the indication of its psilocybin formulation after meeting with the FDA. In addition to treating anxiety related to traumatic brain injury, it could also target depression. A $3M private placement will fund phase Ib/IIa depression study next year.
CHICAGO and TORONTO, March 22, 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, has announced data from an animal study, conducted by an independent global laboratory services provider in a validated model of depression.
Results of the study showed that administration of imipramine given three weeks following a psilocybin loading dose provided an additional 39% further improvement in depressive behaviors from that of psilocybin loading dose alone. Furthermore, a second administration of imipramine given four weeks after a psilocybin loading dose provided an even greater reduction (45%) in depressive behaviors.
“These results demonstrate that psilocybin has the ability to potentiate the effects of antidepressant medications,” said Mark Wingertzahn, Wesana Chief Scientific Officer. “These data could signal a shift in how we develop future clinical treatments for depression using both psilocybin and anti-depressants to optimize outcomes.”
While there are a number of available therapies to treat depression, only 60%–70% of patients respond to antidepressant therapy. Of those who do not respond, 10%–30% exhibit treatment-resistant symptoms1, highlighting the need for additional therapeutic options. Further, despite the established importance of treating depression, only 44% of TBI patients with major depressive disorder received antidepressants or counseling2. Of those treated, there is limited evidence supporting the efficacy of antidepressants in the treatment of post-TBI depression3. These new findings suggest that combination therapy could provide more consistent and robust effects over time.
“I’m proud of the work my team has done to continue investigating the full potential of psilocybin alone and in combination with other medications in order to one day provide tailored medication regimens that have an optimized benefit:risk profile,” added Daniel Carcillo, Wesana Founder and Chief Executive Officer. “I look forward to further investigations to address the massive need in our communities today.”
Additionally, The Company has entered into an engagement letter with MDM Worldwide for the provision of market awareness and investor relations services. The engagement has a six-month term at a rate of US$8,000 per month and upon completion, the issuance of 25,000 Restricted Stock Units (“RSUs”). MDM Worldwide is a digital communications agency that develops and manages online engagement strategies to connect companies with their stakeholders. MDM specializes in working with clients in the technology, healthcare and life sciences spaces.
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1 Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient preference and adherence. 2012;6:369-388.
2 Bombardier CH, Fann JR, Temkin NR, Esselman PC, Barber J, Dikmen SS. Rates of major depressive disorder and clinical outcomes following traumatic brain injury. JAMA. 2010;303(19):1938-45.
3 Robert S. Traumatic brain injury and mood disorders. Ment Health Clin. 2020;10(6):335-345.
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
Forward-Looking Information and Statements
This news release contains “forward-looking information” within the meaning of applicable securities laws relating to future partnerships, collaborative research and the focus of the Company’s business. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance regarding the participation in, or success of, partnerships or collaborative research or that the Company will continue its business as described above. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law. Readers are encouraged to refer to the Listing Statement filed on Company’s profile on SEDAR at www.sedar.com for information as to the risks and other factors which may affect the Company’s business objectives and strategic plans.
Source: Wesana Health
Released March 22, 2022
CHICAGO and TORONTO, March 14, 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, announced that they have received a full written response from the Food and Drug Administration (FDA) regarding their pre-Investigational New Drug (IND) meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD).
The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence with clinical studies for SANA-013. The Company believes the written response provides a path to agreements on IND-enabling studies and validates the team’s effort and accomplishments over the past year. Wesana intends to initiate its in-human clinical study program in late 2022. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD.
Mark A. Wingertzahn, Wesana’s Chief Scientific Officer said, “We are highly appreciative of the clear direction FDA has given us in terms of what will be required to advance SANA-013. We look forward to commencing our clinical development program with their feedback in mind and in full compliance with FDA drug development guidelines.”
SANA-013 is covered under patent applications owned by Wesana and directed to novel composition and novel methods of use. Patent applications detail the use of a loading dose of psilocybin and a maintenance dose of psilocybin given concomitantly with a dose of cannabidiol (“CBD”). This novel combination therapy has demonstrated effectiveness through different and potentially complementary pharmacologic pathways. Unlike therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects beginning as early as a few weeks post administration, SANA-013 is being developed to utilize a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.
“We were pleased with the feedback from the FDA regarding SANA-013,” said Wesana founder and CEO, Daniel Carcillo. “This is the most important work of my lifetime, and I’m truly excited about the successful completion of this engagement and the clarity of guidance provided by the FDA as we move toward our next phase of development for SANA-013.”
Please refer to the Company’s management’s discussion and analysis dated November 29, 2021, available on the Company’s profile on www.sedar.com for additional information as to the Company’s drug development program and the steps required to be completed for the Company to be able to commence phase I clinical trials.
About Wesana Health
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and proprietary protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
Cautionary Note Regarding Forward-Looking Information
This press release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase I clinical trials in late 2022, the patentability of the Company’s therapies or protocols and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
Certain factors that influence successfully initiating its clinical development program in late 2022 include: (i) the Company has retained industry leading experts/consultant to assist with strategy, drafting and submission of pre-IND meeting Package; (ii) preparation of materials and internal discussions with consultants have been ongoing, productive and in line with timeline expectations; (iii) the pre-IND meeting was completed and provided the Company with the requisite guidance as to whether the protocols for the IND enabling studies are sufficient.
Certain assumptions that influence successfully initiating its clinical development program in late 2022 include: (i) third parties who assisted the Company with the pre-IND submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND guidance will continue to support that a drug development plan and future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.
Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to the ability of the Company to protect its intellectual property, changes to patent law, requirements to share intellectual property with service providers, general economic, market and business conditions and other risk factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 773-236-7972
Media Contact:
Izzy Forman
Email: media@wesanahealth.com
Nick Opich / Annie Graf
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206 / 786-390-2644
On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: (773) 236-7972
Tripping on ibogaine can last over 24 hours, and it’s not always pleasant. But the wide range of benefits could make it worthwhile.
MINDCURE (MCUR) hopes so at least. The company filed a provisional patent for synthetic ibogaine mixtures to treat various central nervous system disorders like:
The company aims to be a global supplier of synthetic ibogaine for research purposes and expects to have supply available by the end of Q2 this year.
In a preclinical animal model, Wesana Health (WESA) found that a single high dose of psilocybin rapidly improved depressive behaviours for 14 days. A regimen of psilocybin microdoses and CBD was able to sustain the results and reduced depressive behaviours by an additional 64%.
Let’s keep the microdosing evidence coming!
The majority of patients with traumatic brain injury (TBI) also experience depression, and patients with severe TBI-related depression are 5x more likely to attempt suicide.
Wesana Health (WESA) is planning a study to see if the condition can be treated with one large dose of psilocybin in a clinic, followed by “self-administered maintenance doses” of psilocybin and CBD to sustain the benefits.
Researchers believe the treatment will promote neuroplasticity and neurogenesis while reducing neuroinflammation.
Evidence suggests that microdosing improves cognitive function and memory. This kit could take the benefits up a notch.👇🏽
Ixtlan Bioscience, a private Israeli company, filed a US patent for a microdosing kit that can be used at home to treat Alzheimer’s, brain damage, and neuronal disorders.
The kit includes:
Who knows, maybe this time next year, it’ll be the trending gift to put under the tree. 🎄
CHICAGO and TORONTO, Dec. 14, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company, is pleased to announce receipt of a commercial viability analysis conducted by the Boston Consulting Group (BCG) which validated and will expedite Wesana’s partnership talks with Multidisciplinary Association for Psychedelic Studies (MAPS) and MAPS Public Benefit Corporation (MAPS PBC). The parties will move forward with the negotiation of their definitive agreement to study the use of MDMA-assisted therapy to treat symptoms associated with traumatic brain injury (TBI).
“This analysis brings us one step closer to partnering with Wesana to conduct research into the potential of MDMA-assisted therapy in the underserved TBI population,” said MAPS Executive Director, Rick Doblin, Ph.D. “This market analysis makes the case even more compelling for our partnership.”
Daniel Carcillo, CEO of Wesana Health added, “The receipt of favorable results in the MAPS-commissioned BCG report is a critical milestone in what will be the first-of-its-kind collaboration between MAPS and Wesana, facilitating our definitive agreement conversations regarding MDMA-assisted therapy for TBI symptoms.”
The BCG report forecasts a continuing favorable environment for this collaboration. Should a definitive agreement be entered into, it is expected to accelerate the parties’ research timelines and provide additional support to MAPS for further investigation, advocacy, education, and equitable access to MDMA-assisted therapy for TBI symptoms.
Carcillo continued, “With the overall reported cost of TBI in the range of ~$76.5 billion annually in the US according to the Centers for Disease Control and Prevention, the market is ready for a new solution. We remain committed to this important work as we move toward our goal of MDMA-assisted therapy for TBI symptoms and would be thrilled to deliver meaningful help to victims, families, friends and communities whose lives have been impacted by TBI.”
About Wesana Health
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and proprietary protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com
ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.
ABOUT MAPS PUBLIC BENEFIT CORPORATION
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including the completion and timing of entering into a partnership with MAPS and information concerning the expected benefits thereof; and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
The formation of a partnership between the Company and MAPS remains at a preliminary stage. Certain assumptions that influence successfully forming such a partnership include: (i) the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPS and satisfy any related conditions precedent; and (ii) the ability of the Company to raise sufficient additional capital to be able to fund such potential partnership with MAPS.
Other general assumptions include, operating conditions remaining favorable, including sustained availability of third-party service providers and other inputs for the Company’s operations; sustained political and regulatory stability; and sustained stability in capital goods markets.
While the Company considers the foregoing assumptions to be reasonable, the assumptions are inherently subject to significant business, economic, social, political, regulatory, competitive, and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.
Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual performance, achievements, actions, events, results, or conditions of the Company to be materially different from any future performance, achievements, actions, events, results or conditions expressed or implied by such forward-looking information. Such factors include, among others: inability to negotiate, settle, enter into or execute upon a definitive partnership arrangement with MAPS; inability to raise sufficient additional capital to fund such potential partnership with MAPS; research and development of drugs targeting the central nervous system being particularly difficult; competition from other biotechnology and pharmaceutical companies; maintaining and enhancing reputation and brand recognition; ability to protect intellectual property; requirements to share intellectual property with service providers; negative operating cash flow and going concern; the detrimental impact of future losses and negative cash flow from operations; unfavorable publicity or consumer perception; not achieving publicly announced milestones; psychedelic inspired drugs possibly never being approved as medicines; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; COVID-19; litigation; conflicts of interest; limited operating history; exposure to the fluctuation of foreign exchange rates; enforcement of judgments and effecting service of process on directors and officers; general economic, market and business conditions, and other risks factors including those found in the Company’s management’s discussion and analysis for the three- and nine-months ended September 30, 2021 and 2020 and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
For more information, please contact:
Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 773-236-7972
Media Contacts:
Nick Opich / Fallon Carter
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206
On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: 773-236-7972
Source: Wesana Health
Released December 14, 2021
CHICAGO and TORONTO, Dec. 09, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company, is pleased to announce that it has filed Patent Cooperation Treaty (“PCT”) patent applications towards securing the exclusive rights to protocols, delivery methods and compositions of matter which includes utilizing a high loading dose of psilocybin-assisted psychotherapy, coupled with non-hallucinogenic, low maintenance doses of psilocybin with and without other evidence-based therapies (plant medicines, fungi and adaptogens) to treat neurological based conditions.
This PCT application, filed with the World Intellectual Property Organization will enable Wesana to file patent applications and seek protection in most major markets throughout the world.
These applications are focused on developing novel therapies to treat symptoms associated with traumatic brain injury (“TBI”), such as depression and anxiety, as well as migraines unrelated to TBI among the general population. Overall, any patent efforts in relation to the foregoing are at the patent application stage.
“Since we began our research at Wesana, our goal remains to find novel therapies to help other sufferers of TBI and mental health challenges find hope through effective healing medicine and therapies,” said Daniel Carcillo, Wesana founder and CEO. “As we continue to develop our process and refine our unique solutions, we want to ensure proper IP protection to be able to provide the most innovative methods for proper treatment. To pass this critical milestone and bring us one step closer to accomplishing this goal is truly thrilling.”
Dr. Mark Wingertzahn, Wesana’s Chief Scientific Officer, added “I am excited for this filing as it serves to further advance Wesana’s proprietary development portfolio.”
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.
Cautionary Note Regarding Forward-Looking Information
This press release includes statements or information which may constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, statements with respect to activities, events or developments that the Company expect or anticipate will or may occur in the future, including management’s assessment of future plans, operations and performance and statements with respect to the business plan of the Corporation. In certain cases, forward-looking statements can be identified by terminology such as “may”, “will”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “predict”, “forecast”, “outlook”, “potential”, “continue”, “should”, “likely”, or the negative of these terms or other comparable terminology. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to the ability of the Company to protect its intellectual property, changes to patent law, requirements to share intellectual property with service providers, general economic, market and business conditions and other risk factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
For more information, please contact:
Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 773-236-7972
Media Contacts:
Nick Opich / Fallon Carter
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206
On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: 773-236-7972
Source: Wesana Health
Released December 9, 2021
In honour of Veteran’s Day, we’re sharing the story of how a Special Ops veteran changed his life with DMT.
Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.
After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.
“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”
After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.
“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.
To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.
