Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) just announced its submission of an Investigational New Drug (“IND”) application to the United States Food and Drug Administration (“FDA”) for its TRP-88802 clinical candidate. This application follows the commencement of Tryp’s Phase 2a clinical trial that explores psilocybin-assisted therapy’s safety and preliminary effectiveness among individuals dealing with fibromyalgia.
While making the announcement, Greg McKee, the Chairman and Chief Executive Officer of Tryp, noted, “We have been working diligently to complete this IND submission and are eager to initiate what will be one of the first evaluations of psilocybin to treat fibromyalgia in a Phase 2 study,” (https://ibn.fm/KVqCt).
This trial is being conducted in collaboration with the University of Michigan, spearheaded by Kevin Boehnke, Ph.D. from the university. It will involve 20 fibromyalgia patients and include various exploratory endpoints, particularly given the high prevalence of co-morbidities that include, but are not limited to anxiety, depression, and poor sleep quality.
Since its inception, Tryp has aimed to lead the next wave of psychedelic drug development, pushing beyond mental health. Its focus on psilocybin-based treatments for chronic pain and other indications has proven useful and highly effective. With this specific study, the company seeks to offer a more effective fibromyalgia solution than those that are currently available in the market today. It also aims to provide a long lasting solution with fewer side effects, ultimately affording patients better treatment for their condition.
“Many fibromyalgia patients find insufficient relief from the currently available, FDA-approved treatments for the disease due to their limited efficacy and significant side effects. We have an opportunity with Tryp to conduct a Phase 2a study that evaluates the safety and clinical utility of psilocybin for fibromyalgia as we target the origins of the disease rather than simply treating patient symptoms,” noted Dr. Boehnke.
Research has shown that the administration of psilocybin increases neuroplasticity while also addressing disrupted neural connections that are typically associated with fibromyalgia and other nociplastic pain indications. This Phase 2a study will seek to capitalize on that, starting with the administration of TRP-8802, coupled with psychotherapy. The study is expected to commence in 2022, subject to a favorable review of the IND by the FDA.
“Through our close collaboration with Dr. Boehnke and other experts in the space, we have an appreciation of the limitations of current treatments for this disease and a determination to develop a more effective therapy for the millions of patients suffering from fibromyalgia,” noted Mr. McKee.
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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