KELOWNA BC / ACCESSWIRE / January 8, 2024 / Tryp Therapeutics, Inc. ("Tryp" or the "Company") (CSE:TRYP)(OTCQB:TRYPF), a pioneering clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs,today announced a significant milestone in its clinical trial program for TRP-8803 (IV-infused psilocin). The Company has received approval from the Human Research Ethics Committee (HREC) in Australia to commence the groundbreaking Phase 1 clinical trial of TRP-8803 in healthy human volunteers. This study is designed to determine the optimal blood levels of psilocin needed to achieve the targeted psychedelic state.
The trial, titled "A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of a Single Intravenous (IV) Infusion of TRP-8803 (psilocin) in Healthy Adult Participants," is set to be performed at the CMAX Phase 1 unit in Adelaide, Australia. This study is designed to provide a major advance in psychedelic medicine by aiming to optimize the doses and infusion rates of IV-administered psilocin to achieve targeted blood levels of psilocin. Uniquely, the study will also collect real-time electroencephalogram (EEG) data from all nine human volunteers to monitor changes in EEG patterns associated with the psychedelic state, providing invaluable insights into the correlation between psilocin levels and the depth and duration of the psychedelic experience. This information is critical to advancement of TRP-8803 into future Phase 2 studies.
Jim Gilligan, Ph.D., Tryp's Chief Scientific Officer, shared his enthusiasm regarding the achievement:
"HREC's approval is a pivotal moment in advancing our TRP-8803 program. The PK/PD results from this study will for the first time provide the data to correlate the circulating blood levels of psilocin required to achieve the psychedelic state. Further, the EEG data will assist our understanding between blood levels of psilocin and the depth and duration of the psychedelic experience. Achieving the three predetermined targets of psilocin blood levels in this study and confirming their safety will serve as the basis for dose selection in our planned Phase 2 studies with TRP-8803. Our anticipated receipt of 43.5% of the study costs back in cash via Australia's R&D rebate program will significantly reduce the cost of the study and validates our recently announced plan to redomicile to Australia and list on the Australian Securities Exchange."
TRP-8803 provides a proprietary formulation of psilocin administered by IV infusion. This innovative approach is designed to enhance the positive effects of psilocybin and psilocybin-related compounds while markedly reducing the limitations of psilocybin dosed through other routes of administration. TRP-8803 is anticipated to have faster onset, less patient variability in terms of drug blood levels, and significantly shorter overall duration of treatment. In combination with psychotherapy, TRP-8803 is intended to serve as a treatment for certain neuropsychiatric disorders where efficacy using oral psilocybin has already been demonstrated, but with significantly more commercial feasibility.
Update on TRP-8802 for Abdominal Pain Related to Irritable Bowel Syndrome (IBS)
In parallel, the Company is making strides with its TRP-8802 (oral psilocybin) clinical trial in irritable bowel syndrome (IBS) patients, which is being conducted in partnership with Massachusetts General Hospital (MGH). Following the recent Institutional Review Board (IRB) approval, the study titled "A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Oral Psilocybin (TRP-8802) Administration in Concert with Psychotherapy Among Adult Patients with Irritable Bowel Syndrome" is nearing commencement with patient dosing expected in the first half of 2024.
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp's lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company also recently announced commencement of patient dosing in a Phase 2a clinical trial for the treatment of fibromyalgia in collaboration with the University of Michigan and is preparing to initiate a Phase 2a clinical trial in collaboration with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel syndrome. Each of the studies is utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response is demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety, and patient experience. For more information, please visit www.tryptherapeutics.com.
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Certain information in this news release, including statements relating to the anticipated closing date of the Private Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater 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 the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
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SOURCE: Tryp Therapeutics
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