Tryp Therapeutics Initiates Enrollment for Binge Eating Disorder Study in Partnership with University of Florida

Rhea-AI Summary

Tryp Therapeutics has initiated its Phase 2 clinical trial for TRP-8802, the first FDA and DEA-approved study focusing on binge eating disorder. Conducted at the University of Florida, the open-label trial will enroll up to ten patients to evaluate the safety and effectiveness of psilocybin-assisted therapy. This milestone highlights the potential of psilocybin-based treatments in addressing the unmet needs of those suffering from eating disorders, with the aim to create healthier eating behaviors through neuroplasticity.

Positive

• First FDA and DEA-approved Phase 2 study for psilocybin targeting binge eating disorders.
• Initial patient enrollment marks a significant milestone for Tryp Therapeutics.
• Potential to develop innovative treatments for an increasing number of Americans suffering from eating disorders.

Negative

• None.

Phase 2 study is the first approved by the FDA and DEA to test psychedelic therapies in the area of binge eating disorders

SAN DIEGO, March 23, 2022 /PRNewswire/ -- Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) ("Tryp" or the "Company"), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today the first patient enrolled to evaluate its clinical candidate, TRP-8802, in a clinical trial. The study will investigate the safety and preliminary effectiveness of psilocybin-assisted therapy among patients with binge eating disorders in collaboration with the University of Florida.

Conducted in Gainesville, Florida, the open-label trial will target a group of up to ten patients. Dr. Jennifer Miller, a Professor of Pediatric Endocrinology at University of Florida who specializes in the care and treatment of individuals with a variety of eating disorders, including binge eating and hypothalamic-induced obesity, will serve as Principal Investigator of the trial.

"Initiation of patient enrollment is a significant milestone for the Company, which to our knowledge will be the first evaluation of psilocybin to treat binge eating in a Phase 2 study," stated Jim Gilligan, Interim Chief Executive Officer of Tryp Therapeutics. "The key objective of this clinical trial is to confirm that the neuroplasticity attributes of psilocybin will help create healthy neural connections that address the unhealthy eating behaviors of patients with binge eating disorders. In addition to evaluating the effectiveness of psilocybin in this patient population, the results will help guide future clinical studies using Tryp's proprietary psilocybin-related molecule (TRP-8803) for our targeted indications."

"Psilocybin-based drugs, including TRP-8802 and TRP-8803, have the potential to be life-changing treatments for binge eating adults. As the number of Americans suffering from eating disorders increases and current treatment paradigms fail to provide the necessary relief, a new, fast-acting, effective solution is imperative. Enrollment of the first patient into our S.T.O.P (Study of the Treatment of Overeating utilizing Psilocybin) trial for binge eating disorder further reflects our commitment to go beyond the current standard of care and meet the needs of those suffering from eating disorders," stated Dr. Jennifer Miller. "We hope this treatment paradigm will allow patients to live a normal, fulfilling life."

About Binge Eating Disorder (BED)

• BED is characterized by recurring episodes of eating large quantities of food and feeling unable to stop.
• Nearly 30% of people seeking weight loss treatments show signs of BED.
• Up to 3.5% of females and 2.0% of males will develop BED at some point in their lives - nearly 4 million women and 2 million men; treatments to date have not been effective.

About TRP-8802

• TRP-8802 is a non-proprietary 25 mg oral capsule of synthetic psilocybin.
• Using TRP-8802 for Phase 2a studies allows Tryp to quickly initiate clinical trials to generate initial data while they concurrently develop an improved, proprietary formulation and delivery system for psilocybin-related molecules for target indications like BED.

About Tryp Therapeutics
Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-related molecules, including TRP-8803, for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp's Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin-related molecules as a new class of drug for the treatment of binge eating, chronic pain, and other indications. The Company has begun enrolling patients in its Phase 2 trial for the treatment of binge eating disorder at the University of Florida and recently announced an upcoming Phase 2a clinical trial with the University of Michigan to evaluate its drug products for fibromyalgia. TRP-8803 is a proprietary psilocybin-based product that uses a novel formulation and route of administration to improve both efficacy and the patient experience. For more information, please visit www.tryptherapeutics.com.

Investor Relations:
Jim Gilligan, Interim CEO
Tryp Therapeutics
jgilligan@tryptherapeutics.com 

Media Relations:
Annie Graf
KCSA Strategic Communications
tryp@kcsa.com 

Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans," "targets," "expects" or "does not expect," "is expected," "an opportunity exists," "is positioned," "estimates," "intends," "assumes," "anticipates" or "does not anticipate" or "believes," or variations of such words and phrases or state that certain actions, events or results "may," "could," "would," "might," "will" or "will be taken," "occur" or "be achieved." In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the "Risk Factors" section of Tryp's final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

View original content to download multimedia:https://www.prnewswire.com/news-releases/tryp-therapeutics-initiates-enrollment-for-binge-eating-disorder-study-in-partnership-with-university-of-florida-301508507.html

SOURCE Tryp Therapeutics

FAQ

What is the focus of Tryp Therapeutics' Phase 2 clinical trial for TRP-8802?

The trial focuses on the safety and preliminary effectiveness of psilocybin-assisted therapy for binge eating disorders.

Where is the Phase 2 trial for TRP-8802 being conducted?

The trial is being conducted at the University of Florida in Gainesville, Florida.

What is the potential impact of psilocybin-based treatments according to Tryp Therapeutics?

Psilocybin-based treatments could be life-changing solutions for adults suffering from binge eating disorders.

When did Tryp Therapeutics initiate patient enrollment for the binge eating disorder study?

Patient enrollment for the study was initiated on March 23, 2022.

What role does Dr. Jennifer Miller play in the clinical trial?

Dr. Jennifer Miller is the Principal Investigator for the trial, specializing in treating eating disorders.