First-ever study with direct psilocin

Filament Health Announces FDA Authorization of Clinical Trial with First-ever Direct Psilocin Administration and First-ever Psychedelic Botanical Drug Candidates

When psilocybin is consumed, it’s metabolized into psilocin, which is the compound that produces most or all of the psychedelic effects. Will the experience change if is psilocin is administered directly?

Filament Health (FH) just received FDA-approval for a first-of-its kind study that will reveal the answer.

The phase I trial at the University of California San Francisco will compare the effects psilocybin and psilocin in 20 healthy patients. Psilocybin will be administered orally, whereas psilocin will be administered both orally and sublingually, meaning it will be absorbed through tissues under the tongue.

Researchers predict that direct psilocin could result in faster onset times, greater consistency and bioavailability, and fewer side effects.

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Filament Health Announces FDA Authorization of Clinical Trial with First-ever Direct Psilocin Administration and First-ever Psychedelic Botanical Drug Candidates

Filament Health Announces FDA Authorization of Clinical Trial with First-ever Direct Psilocin Administration and First-ever Psychedelic Botanical Drug Candidates

The Phase 1 Trial is Taking Place at the Translational Psychedelic Research Program at the University of California San Francisco

Vancouver, British Columbia, November 2, 2021  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), an exclusively-natural psychedelic drug discovery company, announces FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. In addition, this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates,” said Chief Executive Officer, Benjamin Lightburn. “Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”

The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial.

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic,” said Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator. “The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic assisted therapy.”

Further information about the history and benefits of psilocin can be found at https://filament.health/psilocybin-vs-psilocin.

 

ABOUT FILAMENT HEALTH

Filament Health is an exclusively-natural psychedelic drug discovery and extraction technology company. Its mission is to see safe, approved, natural psychedelics in the hands of everyone who needs them as soon as possible. Filament believes measurable and efficacious medicines will be a catalyst to addressing many of the world’s mental health problems and that natural psychedelics provide an optimal option for widespread adoption of these substances. Filament engages in natural extraction technology commercialization, utilizing its intellectual property portfolio, and its subsidiary Psilo Scientific’s in-house GMP facility, and Health Canada Dealer’s License for all natural psychedelics. Filament is headquartered in Vancouver, British Columbia and trades on the OTCQB Venture Market (OTCQB:FLHLF), Canada’s NEO Exchange (NEO:FH), and the Frankfurt Stock Exchange (FSE:7QS).

Learn more at www.filament.health and on TwitterInstagram and LinkedIn.

 

MEDIA RELATIONS

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

 

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
FilamentIR@KCSA.com

 

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including results of the clinical trial. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

  • Completing IND-enabling studies with novel microneedle patch for ketamine, psilocybin, MDMA, LSD, and DMT.
  • Expanding research in evaluating ibogaine and mescaline.
  • Aiming for FDA Phase 1 and 2 clinical studies in Q2-2022.
  • Discussing partnership opportunities for delivering psychedelics with MicroDose-MN™ and MacroDose-MN™ patches.
TORONTO, November 1, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today provides an update on the ongoing research studies with its novel microneedle (“MN”) patch as a next generation delivery technology for psychedelics, including ketamine, psilocybin, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).

The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.

Research results with MicroDose-MN™ for psilocybin and LSD will be made available in November 2021, followed by results with MDMA and DMT in December 2021.  Research results with MacroDose-MN™ for ketamine and KETABET™ will be made available in December 2021.  Current research results are very encouraging; therefore, the Company has decided to expand research to include ibogaine and mescaline, prepare IND applications with the FDA for Phase 1 and 2 clinical studies in Q2-2022, and discuss partnership opportunities with specialty pharmaceutical companies seeking a novel and validated delivery system for psychedelics targeting specific indications and desired pharmacokinetic profiles.

PharmaTher is proceeding with its IND-enabling studies and manufacturing scale-up for cGMP microneedle patches for its expected clinical studies in 2022.  The MicroDose-MN™ and MacroDose-MN™ patches can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are nearing completion of our research programs in validating the utility of our microneedle patch delivery technologies for psychedelics, derisking our plans in advancing the completion of our IND-enabling studies to support future clinical studies and partnering opportunities,” said Fabio Chianelli, CEO of PharmaTher.  “As we look forward to announcing our research results, our focus continues to expand our ketamine-based product pipeline and advance our microneedle patch programs to unlock significant value and return on investment for long-term revenue potential through our products and our future partners.”

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Be an early investor 🤑

Emotional Intelligence Ventures Reg A Raise at $20M, Company Pursues Psilocybin Transdermal Delivery Research, Plans Nutraceutical Mushroom Supplements Launch

Want to be an early investor in a psychedelics company? Now’s your chance!

Ei.Ventures is currently looking to raise $50M through a Regulation A+ Framework – a type of offering that allows the general public, not just institutional or accredited investors, to buy shares in a company before it goes public.

“I’m really passionate about democratizing investment opportunities so any investor can reap the rewards, and take all of the risks of early investment in game-changing companies,” said David Nikzad, the company’s founder, who was an early investor in Airbnb , Betterment, and Vidyard.

Ei.Ventures is developing a transdermal psilocybin patch and is preparing to launch a functional mushroom line early next year. Shares are selling for $4.94 each with a minimum purchase of 101 shares, and the company has already raised $20M.  Take advantage of the offer here.

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Is MDMA the Viagra for women?

LOVE PHARMA INC., ANNOUNCES LISTING ON FRANKFURT STOCK EXCHANGE

A Vancouver company called LOVE Pharma (LUV) wants to promote mental and sexual wellness with its growing product line.

The company recently launched two products (a CBD oral strip and a clitoral stimulation gel) and has exclusive rights to a total of seven novel therapeutic products. It’s currently developing a biosynthetic psilocybin strip using the IP from the CBD strip.

On Tuesday, the company was listed on  the Frankfurt Stock Exchange under the symbol “G1Q0”.

In other sexual wellness news, Mindcure (MCUR) recently launched a research program to treat female hypoactive sexual desire disorder (HSDD), a disorder involving low sex drive and emotional distress, with MDMA-assisted therapy.

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Never leave home without your inhaler ;)

Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

Cybin Inc. (CYBN) developed a new device that delivers psychedelic medicine through inhalation.

Inhaling psychedelics could be superior to oral administration, as it could result in optimized session timing, lower doses, and greater control for healthcare providers.

The company filed an international patent application for the method and the device, which has potential to gain coverage in 153 countries.

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Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

Cybin Files an International Patent Application Covering Psychedelic Delivery Methods

Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biotechnology company focused on progressing psychedelic therapeutics, today announced that it has filed an international patent application related to methods for the delivery of psychedelic medications by inhalation and devices for performing those methods.

The application, governed by the Patent Cooperation Treaty (“PCT”), brings the potential to obtain patent coverage in 153 countries.

The Company believes that the delivery of psychedelic medications using inhalation may overcome key obstacles encountered by traditional oral drug administration. Specifically, the Company expects inhalation delivery to facilitate optimized psychedelic session timing compared to oral administration of the same compounds, lower doses of psychedelic therapeutics while preserving efficacy, and providing health care providers with more control during psychedelic sessions.

Filed in support of the Company’s CYB004 pre-clinical development program, the PCT filing serves to increase the Company’s library of drug delivery modalities directed to optimal delivery of psychedelics and further strengthens Cybin’s growing IP portfolio.

The PCT filing also includes support for future research programs respecting various systems which seek to minimize negative side effects in psychedelic psychotherapy patients, methods that enable lower and sub-psychedelic doses without impacting treatment efficacy and increasing the long-term efficacy of psychedelic sessions.

“The continued progression of our research programs guides our discovery of new molecules and differentiating treatment approaches. Continued innovation, as demonstrated by our expanding IP portfolio, positions Cybin as a leading innovator in the development of putative psychedelic treatments for a variety of mental health conditions,” said Doug Drysdale, the company’s CEO.

About Cybin
Cybin is a leading biotechnology company focused on progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for psychiatric 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 development of innovative drug delivery systems, novel formulation approaches and potential treatment regimens for psychiatric disorders and proprietary development strategy and development of medicinal psychedelics with improved dosing efficacy and therapeutic indices to address unmet medical needs.

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 three months ended June 30, 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 or nutraceutical products. 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 or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous 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.

The Neo Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

Investor Contacts:
Tim Regan/Scott Eckstein
KCSA Strategic Communications
Cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Media Contact:
John Kanakis
Cybin Inc.
John@cybin.com

Source: Cybin Inc.

Let me hit that vape

Delic to Acquire Ketamine Wellness Centers Inc, Becoming Largest Psychedelic Wellness Chain in United States

Will psychedelic therapy soon involve vaping shrooms?

Delic Holdings Corp. (DELC) is the first company to receive Health Canada approval to research psilocybin vaporization.

On Monday, Delic entered into an agreement to acquire Ketamine Wellness Clinics, a company that runs 10 ketamine infusion centers across 8 states. The deal increases Delic’s total number of clinics to 12 and adds over 60 medical professionals to the team, making it the largest psychedelic wellness chain in the US. Within the next 18 months, the company hopes to grow this number to 27 clinics!

Once granted FDA-approval, DELIC aims to offer other psychedelic treatments at these locations including MDMA and psilocybin therapy, which could potentially use the vaporization technology!

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The best way to take psilocybin?

A Hawaiian company called Ei.Ventures is partnering with Tioga Research to develop a new psilocybin delivery method.
The companies are developing a patch that delivers psilocybin through the skin using the same transdermal technology found in nicotine patches.

The patch allow for more stable delivery of psilocybin and could prevent nausea that often occurs with oral administration. The product is designed for high doses of psilocybin, but could potentially be used to deliver microdoses for mental clarity and mood stabilization too.

Sounds a bit nicer than the nasal sprays and injection devices that other companies are working on!

Will psychedelics become take-at-home prescription drugs?

Psycheceutical, Inc. Announces New Patents that Enable Psychedelic Compounds to be Administered as Pharmaceutical Medicines

Most psychedelics are administered through the digestive tract, but this can require higher dosages, slow the absorption, and can have unwanted side effects. Psycheceutical Inc. is taking a different route.

The Miami-based company just received two patents that could turn psychedelics into safe and effective take-at-home drugs.

The first is for the Janus particle technology, which uses layers of nanoparticles to target specific cells. The technology can deliver multiple medicines simultaneously at different rates and times.

The second patent is for the company’s NeuroDirect technology, a delivery system that administers compounds directly to nerve connections in the brain. This method bypasses the blood-brain-barrier, which will allow for smaller doses, faster responses, and improved efficacy.

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