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Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) Updating Trial Protocols in Response to FDA Request as Tryp Prepares Synthetic Psilocybin Studies for Eating Disorder, Fibromyalgia Treatment

  • Pharmaceutical company Tryp Therapeutics is investigating the potential of synthetic psychedelic drug candidates to treat unmet medical needs
  • The company is evaluating two drug products labeled TRP-8802 and TRP-8803 for treating fibromyalgia, phantom limb pain, complex regional pain syndrome and select eating disorders
  • The company has filed its first two INDs with the FDA for planned Ph 2a clinical trials relating to fibromyalgia and eating disorder treatments
  • In the wake of changes recommended by the FDA to the eating disorders trial, Tryp is in the process of updating its protocols and patient consent form to meet the FDA’s expectations
  • Tryp anticipates completing preparations for the phantom limb pain and complex regional pain syndrome studies in partnership with investigators in the University of California system

Pioneering psychedelic medicine pharmaceutical company Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) is advancing toward the launch of four Phase 2a studies of its two novel drug candidates, laying the groundwork for clinical trials at the University of Michigan and the University of Florida for treating pain and eating disorders, which includes making some adjustments to one of the trials recently requested by the FDA.

Tryp’s synthetic psilocybin program includes the development of drug candidates TRP-8802 and TRP-8803 for treating fibromyalgia, phantom limb pain, complex regional pain syndrome (“CRPS”) and select eating disorders. Tryp filed an IND with the U.S. Food and Drug Administration in September for treating overeating disorders in Florida, and filed its second IND application earlier this month for fibromyalgia testing in Michigan (https://ibn.fm/fzSc4).

The FDA asked Tryp to change the scope of its eating disorders trial so that the initial Florida investigation can focus on patients with binge eating disorder. Because the company was also planning to recruit patients with a range of overeating disorders including Prader-Willi Syndrome (“PWS”) and hypothalamic obesity disorder resulting from the removal of a brain tumor, the FDA asked the company to break off the hypothalamic obesity disorder testing and file a separate IND for a potential fifth clinical study regarding those patients.

“We appreciate the feedback from the FDA on our clinical activities for binge eating disorder and hypothalamic obesity patients,” Tryp Chairman and CEO Greg McKee stated in a Nov. 18 news release (https://ibn.fm/JzrbX). “We look forward to advancing our synthetic psilocybin programs for the benefit of patients and clinicians alike.”

McKee stated the company would submit a formal response to the FDA within 10 days of the news release outlining changes to the eating disorders clinical trial and its informed consent form, and added that the FDA indicated it would respond to those modifications within 30 days.

McKee told Trader TV that the company is excited to begin dosing patients in the Florida eating disorder study and the Michigan fibromyalgia study as soon as the final steps are taken care of, and that the company is working with educational partners in the University of California system to prepare for the anticipated phantom limb pain and CRPS trial filings (https://ibn.fm/qN79d).

“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.

The clinical trials will use TRP-8802. TRP-8803 will be developed as a proprietary, synthetic psilocybin drug candidate designed to advance the company through Phase 2b clinical trials that evaluate the drug candidate’s ability to penetrate the natural blood-brain barrier to more effectively alleviate pain and addiction, using a novel route of administration that will lead to more precise control over the patient’s psychedelic experience during the treatment.

Tryp plans to administer TRP-8802 in 25 mg oral dosing, and was enthused by the report of Compass Pathways at the recent Wonderland: Miami conference where Compass reported its own success using 25 mg oral dosing of psilocybin in combination with psychotherapy to treat resistant depression, which Tryp regards as validation of its hypothesis (https://ibn.fm/tdtpR).

For more information, visit the company’s website at 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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