Enables a potentially scalable model for large-scale deployment of psychedelic treatments
Company to host investor update on Tuesday, October 4e
KELOWNA, British Columbia, Oct. 03, 2022 (GLOBE NEWSWIRE) — Therapeutic TrypInc. (CSE: TRYP) (OTCQB: TRYPF) (“try“or the”Company“), a clinical-stage biotechnology company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that the World Intellectual Property Organization (WIPO) has published its application patent application (PCT/IB2022/052347) covering the intravenous administration of psilocybin and psilocin. The PCT application, titled “Improved Methods for the Use of Psychedelics” extends and strengthens the intellectual property related to the company’s development of TRP -8803, an IV formulation of psilocin, which will be administered in conjunction with psychotherapy.
The patent application includes a unique and proprietary formulation and delivery system to enhance the positive effects of psilocybin and psilocin in particular, while significantly reducing the limitations of dosed psilocybin by other routes of administration, including oral, nasal and sublingual. Oral administration, while convenient, presents several limitations and challenges that TRP-8803 can address, including:
Control the onset delay of the psychedelic experience
- Oral administration of psilocybin may take 1-2 hours to induce the psychedelic state; IV infusion can reduce this time period to less than 30 minutes.
Manage the duration of the psychedelic experience
- With oral administration, the psychedelic state, once started, can last 6 to 8 hours, a heavy burden for the patient and the two psychotherapists; IV administration allows the practitioner to manage the duration of the psychedelic state and potentially shortens the overall duration to 1-2 hours.
Achieve clinically validated blood levels of psilocin
- When administered orally, the bioavailability of psilocybin may be reduced due to first-pass metabolism in the liver. Psilocybin is a pro-drug that must be converted into psilocin, the active molecule that crosses the blood-brain barrier and induces the psychedelic state. These factors contribute to varying blood levels of psilocin, which may be too low or too high. High blood levels are associated with side effects, while low blood levels of psilocin can reduce effectiveness; IV administration allows for more precise dosing that achieves optimal blood levels of psilocin, improving the likelihood of achieving clinical endpoints and efficacy while maintaining safety.
Personalize the psychedelic experience
- Intravenous administration offers more control over the experience, allowing the treating psychotherapist to increase or decrease both the strength and duration of the psychedelic experience. Conversely, if the patient experiences a side effect, the clinician can discontinue administration of the drug, an option not available with oral administration.
With these benefits, in particular the ability of TRP-8803 to reduce time spent with healthcare professionals in clinical settings, the company believes there is a clear path to wider commercial acceptance and use of TRP-8803. in conjunction with psychotherapy. Oral psychedelics have been widely introduced for use in the treatment of depression, PTSD, OCD, and other conditions, most notably by Tryp Therapeutics and its TRP-8802 programs. The Company plans to leverage its current clinical studies using TRP-8802 for the treatment of binge eating disorder and chronic pain to improve TRP-8803’s chances of success, with the additional goal of provide value to indications beyond those that Tryp is currently pursuing. .
Jim Gilligan, CEO of Tryp Therapeutics, said: “The oral administration of psilocybin has provided valuable advances in the combined use of psychedelics and psychotherapy, but oral therapies also have recognized limitations. We are excited to introduce the unique and exclusive IV delivery of TRP-8803, which we believe can change the landscape of psilocybin therapies.
“In addition to providing the clinician with greater control over the psychedelic experience, from the initiation of the psychedelic experience, to the achievement of targeted blood levels, to a controlled duration of the experience, TRP-8803 also allows for a shorter overall clinical session.Our ability to reduce the in-clinic experience from 8 hours to approximately 2 hours is not only attractive to patients, we also expect it will create a more scalable model for the broad and effective deployment of psychedelic treatment, not just for the indications we are focused on but other indications as well. We remain focused on expanding our patent portfolio as we continue to develop new, evolving, psychedelics and psychotherapeutics for broader indications and with the publication of the PCT, we look forward to discussing the merits of TRP-8803 with collaborators and investors.
Robin Carhart-Harris, Ph.D., Chair of the Scientific Advisory Board of Tryp Therapeutics, commented, “By enabling rapid initiation and termination of the psychedelic experience, as well as providing highly refined control over the depth and the duration of this experiment, I believe that TRP-8803 has very strong potential to change the paradigm of treatment for fibromyalgia and binge eating, as well as certain types of depression, pain, and obsessive-compulsive disorder.
Conference call information
The company will host a conference call tomorrow, Tuesday, October 4, 2022 at 9:00 a.m. ET to discuss TRP-8803.
The investor can use this link to access the live webcast.
To join the call by phone, dial (888) 506-0062 approximately five minutes before the scheduled start time. For international callers, please dial (973) 528-0011. Callers must use the access code: 474888.
A replay of the conference call will be available until October 18, 2022 and can be accessed by dialing (877) 481-4010. International callers can dial (919) 882-2331. Callers should use conference ID: 46661.
About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on the development of psilocybin-like molecules, including TRP-8803, for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program focuses on the development of synthetic molecules related to psilocybin as a new class of drugs for the treatment of binge eating, chronic pain and other directions. The company has begun enrolling patients in its Phase II trial for the treatment of binge eating at the University of Florida and recently announced an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP- 8802 for fibromyalgia. TRP-8803 is a proprietary psilocybin product that uses a new formulation and route of administration to potentially improve efficacy, safety, and patient experience. For more information, please visit www.tryptherapeutics.com.
Certain information contained in this press release constitutes forward-looking information. In some, but not necessarily all, cases, forward-looking information may be identified by the use of forward-looking terminology such as “anticipates”, “target”, “expects” or “does not expect”. to”, “is expected”, ” “, events or results “may”, “might”, “could”, “could”, “will” or “will be taken”, “will occur” or “will be achieved”. In addition, any statement that refers to expectations, projections or other characterizations of future events or circumstances contains forward-looking information. Statements containing forward-looking information are not historical facts but rather represent expectations, estimates and management’s projections of future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates which, although considered reasonable by Tryp as of the date of this press release, are subject to known and unknown risks, uncertainties , assumptions and other factors that may cause actual results, level of activity, performance or achievements to differ materially from those expressed or implied by such forward-looking information, including, but not limit, the factors described in more detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of factors that could affect Tryp; however, these factors should be carefully considered. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this press release are made as of the date of this press release, and Tryp expressly disclaims any obligation to update or modify any statements containing forward-looking information, or the underlying factors or assumptions, that whether as a result of new information, future events or otherwise, except as required by law.
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