Tryp Therapeutics (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, has received approval from Australia’s Human Research Ethics Committee (“HREC”) to commence a groundbreaking phase 1 clinical trial of TRP-8803 (IV-infused psilocin) in healthy human volunteers. According to the announcement, this is a “significant milestone” in Tryp’s clinical trial program for TRP-8803. This study is focused on identifying optimal blood levels of psilocin needed to achieve the targeted psychedelic state. The trial will be conducted at the CMAX Phase 1 unit in Adelaide, Australia and will gather information that is critical to advancement of TRP-8803 into future phase 2 studies. Tryp’s TRP-8803 provides a proprietary formulation of psilocin that is administered by IV infusion.
According to the company, the formulation is designed to enhance the positive effects of psilocybin and psilocybin-related compounds while reducing the limitations of psilocybin dosed through other routes of administration. Benefits of TRP-8803 could include faster onset, less patient variability in terms of drug blood levels and significantly shorter overall duration of treatment. “HREC’s approval is a pivotal moment in advancing our TRP-8803 program,” said Tryp Therapeutics chief scientific officer Jim Gilligan, PhD, in the press release. “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.”
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About Tryp Therapeutics Inc.
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 has 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 benefit has been 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 about the company, please visit www.TrypTherapeutics.com.
NOTE TO INVESTORS: The latest news and updates relating to TRYPF are available in the company’s newsroom at https://ibn.fm/TRYPF
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