FDA green lights Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) Psychedelic Drug Trial for Treating Fibromyalgia, After Completing IND Process

December 6, 2021 13:39:38
  • Pharmaceutical company Tryp Therapeutics is advancing research into the ability to treat unmet medical needs by using synthetic psychedelic drug candidates generally regarded as illegal and of no practical value under federal drug standards
  • The company is demonstrating its faith in the potential of psychedelic medicine by advancing its proprietary TRP-8802 psilocybin candidate toward Phase 2a drug trials through the FDA’s Investigational New Drug process
  • The FDA has notified the company that its review of the IND for using TRP-8802 to treat fibromyalgia is complete and a trial planned in conjunction with the University of Michigan may proceed to patient enrollment
  • Tryp is also preparing Phase 2a drug trials for testing TRP-8802 in treating eating disorders at the University of Florida, and for treating phantom limb pain and complex regional pain syndrome
Psychedelic drug medical research firm Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) has received final U.S. Food and Drug Administration (“FDA”) approval to get under way with its planned clinical study of its synthetic psilocybin drug candidate TRP-8802 for treating fibromyalgia. “The upcoming Phase 2a study with the University of Michigan for fibromyalgia represents a significant milestone for Tryp’s clinical programs,” Tryp Chairman and CEO Greg McKee stated in the Dec. 2 announcement (https://ibn.fm/aAqGr). “We are eager to begin enrolling patients in the study next year considering the significant, unmet needs of fibromyalgia patients.” The U-M study involves 25 mg dosing of TRP-8802 and combining that with psychotherapy under the care of trained therapists to “create the proper mindset for the neuroplasticity benefits of psilocybin to take full effect” (https://ibn.fm/yJyY8), helping the patients’ brains adapt and change beneficially so that they can overcome the deleterious effects of fibromyalgia by disrupting “neural connections that have been reported for nociplastic pain indications,” according to the announcement. The fibromyalgia study is the first of several Phase 2a trials Tryp Therapeutics anticipates for its synthetic psilocybin product. The company also plans to test TRP-8802’s efficacy in treating phantom limb pain, complex regional pain syndrome (“CRPS”) and select eating disorders. The company has already filed an Investigational New Drug (“IND”) application with the FDA for treating overeating disorders in conjunction with the University of Florida, similar to the U-M trial for fibromyalgia, but the FDA has requested some modifications to the UF project before the trial can proceed. The company is working with testing partners in the University of California’s educational system to prepare IND filings for the TRP-8802 trials treating phantom limb pain and CRPS. “Compared to other companies in the psychedelic drug development space, we’re going to have these four phase 2a clinical trials, which puts us in pretty rarefied air on top of the fact that we’re working in some therapeutic areas with patients that that really not a lot of other companies are looking at this time,” McKee said in a told Trader TV interview (https://ibn.fm/zjRTE). According to the company, its trial for examining TRP-8802’s effects on fibromyalgia patients will be one of the first of such evaluations of synthetic psilocybin in a Phase 2 study. The U-M study, under the direction of Kevin Boehnke, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center, will enroll 20 fibromyalgia patients for the open label clinical trial. It will establish analytical endpoints related to poor sleep quality, depression, anxiety and other conditions common to fibromyalgia patients. Following completion of the 2a trials, Tryp plans Phase 2b trials using its drug candidate TRP-8803 to more effectively alleviate pain and addiction by using a novel route of administration across the blood-brain barrier that is expected to lead to more precise control over the patient’s psychedelic experience during the treatment. For more information, visit the company’s website at www.TrypTherapeutics.com. 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