- Tryp just announced FDA confirmation for its IND application filed in November 2021
- The confirmation allows the company to proceed with its Phase 2a study on the effectiveness of psilocybin-assisted therapy among patients with fibromyalgia
- This clinical study will be one of the first to evaluate synthetic psilocybin for fibromyalgia in a Phase 2 study
- It is set to commence in 2022 and will involve 20 fibromyalgia patients
Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) just announced that it would be proceeding with its upcoming Phase 2a fibromyalgia study, following a confirmation from the U.S. Food and Drug Administration (“FDA”) (https://nnw.fm/I7rB0).
Tryp submitted an Investigational New Drug (“IND”) application in November 2021 for its lead drug candidate, TRP-8802, to investigate the safety and preliminary effectiveness of psilocybin-assisted therapy among patients living with fibromyalgia (https://nnw.fm/7NOrl). The Phase 2a study, conducted in collaboration with Kevin Boehnke, Ph.D. from the University of Michigan, is set to kick off in 2022.
This study will enroll 20 fibromyalgia patients and include a variety of secondary and exploratory endpoints, considering the high prevalence of co-morbidities such as poor sleep quality, anxiety, depression, and other conditions that patients living with fibromyalgia deal with every day.
“The upcoming Phase 2a study with the University of Michigan for fibromyalgia represents a significant milestone for Tryp’s clinical programs. We are eager to begin enrolling patients in the study next year considering the significant, unmet needs of fibromyalgia patients,” noted Greg McKee, the Chairman and Chief Executive Officer (“CEO”) of Tryp Therapeutics.
This clinical study will be among the first evaluations of synthetic psilocybin for fibromyalgia in a Phase 2 study. It is projected that the administration of psilocybin will increase neuroplasticity and address disrupted neural connections associated with nociplastic pain indications.
Most importantly, this study will work towards shaking up the clinical thinking on how to deal with such neurological conditions while laying down the foundation for Tryp’s further studies using their novel, trademarked drug candidates.
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://nnw.fm/TRYPF
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