Tryp Therapeutics Inc. announced that the World Intellectual Property Organization (WIPO) published their international patent application (PCT/IB2022/052347) covering the intravenous administration of psilocybin and psilocin. The PCT application, titled ôImproved Methods For The Use of Psychedelicsö expands and strengthens the IP related to the CompanyÆs 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 in particular psilocin, while markedly reducing the limitations of psilocybin dosed through other routes of administration, including oral, nasal and sublingual.

Oral administration, while convenient, has several limitations and challenges that TRP-8803 can address, including: Controlling time to onset of psychedelic experience; Oral administration of psilocybin can take 1 to 2 hours to induce the psychedelic state; IV infusion can reduce this time period to within 30 minutes. Managing the duration of the psychedelic experience; With oral administration the psychedelic state, once started, can last 6-8 hours, a significant burden to 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. Achieving clinically validated blood levels of psilocin; When orally administered, psilocybinÆs bioavailability can be reduced due to first pass metabolism in the liver.

Psilocybin is a pro-drug which needs to be converted to psilocin, the active molecule that crosses the blood brain barrier and induces the psychedelic state. These factors contribute to variable blood levels of psilocin, which can be either too low or too high. High blood levels are associated with side effects, while low blood levels of psilocin can reduce efficacy; IV administration enables more precise dosing which achieves optimal blood levels of psilocin, thereby improving the likelihood of achieving clinical endpoints and efficacy while preserving safety.

Customizing the psychedelic experience; IV administration provides more control over the experience, allowing the attending psychotherapist to increase or decrease both the strength and duration of the psychedelic experience. Conversely, should the patient experience a side effect, the clinician can terminate administration of the drug, an option not available with oral administration. With these advantages, particularly TRP-8803Æs ability to reduce the time spent with medical professionals in a clinical setting, the Company believes there is a clear path to scaling broader commercial acceptance and use of TRP-8803 in conjunction with psychotherapy.

Orally administered psychedelics have been widely introduced for use in treating depression, PTSD, OCD and other conditions, including 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 disorders and chronic pain to improve the likelihood of success for TRP-8803, with the additional goal of providing value to indications beyond those that Tryp is currently pursuing.