Tryp Therapeutics Provides Update on Clinical Hold for Phase 2a Study for Eating Disorders

Rhea-AI Summary

Tryp Therapeutics (CSE:TRYP; OTCQB:TRYPF) announced on November 18, 2021, that it has received feedback from the FDA regarding its IND application for a clinical study in overeating disorders. The FDA requested protocol modifications, which include focusing the initial phase 2a study on binge eating disorder and submitting an IND for a separate phase 2a study for hypothalamic obesity. Tryp plans to respond to the FDA within 10 days, expecting a reply within 30 days. The company aims to advance its psilocybin-based therapies for these specific conditions.

Positive

• FDA feedback received on IND application indicates ongoing regulatory engagement.
• Modifications to focus study on binge eating disorder may enhance clinical relevance.
• Plans for a phase 2a study targeting hypothalamic obesity could expand market potential.

Negative

• Modifications requested by the FDA suggest initial protocol submitted may have deficiencies.

SAN DIEGO, Nov. 18, 2021 /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 that it has received correspondence from the U.S. Food and Drug Administration ("FDA") related to the Company's Investigational New Drug ("IND") application for a clinical study in overeating disorders.

The FDA has requested certain changes to the protocol of the upcoming study, and Tryp will be modifying the protocol to incorporate all of the FDA's requests.  The primary changes include the following:

• Focusing enrollment of the initial phase 2a study on patients with binge eating disorder
• Submitting an IND for a separate phase 2a study to evaluate the use of synthetic psilocybin for patients with hypothalamic obesity

Tryp expects to submit a formal response to the FDA within the next 10 days outlining the modifications to the protocol and informed consent form for the study to comply with the requests.  The FDA has indicated that it will then respond to the modifications within 30 days.

Commenting on the development, Greg McKee, Chairman and CEO of Tryp, stated, "We appreciate the feedback from the FDA on our clinical activities for binge eating disorder and hypothalamic obesity patients.  We look forward to advancing our synthetic psilocybin programs for the benefit of patients and clinicians alike."

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds 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 as a new class of drug for the treatment of chronic pain and other indications. The Company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and overeating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and route of administration to improve the patient experience.  For more information, please visit www.tryptherapeutics.com.

Investor Relations:
Joseph Green
Edison Group
investors@tryptherapeutics.com

Media Relations:
Abby Berger
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 including, but not limited to, the expected timing for providing a response to the FDA. 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.

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SOURCE Tryp Therapeutics

FAQ

What updates did Tryp Therapeutics provide regarding its IND application for overeating disorders?

Tryp Therapeutics announced that the FDA requested changes to its IND application, focusing the initial phase 2a study on binge eating disorder and adding a new study for hypothalamic obesity.

What is the timeline for Tryp's response to the FDA?

Tryp expects to submit a formal response to the FDA within the next 10 days, with the FDA indicating they will respond within 30 days.

How does the FDA's request affect Tryp's clinical trials?

The FDA's request for protocol modifications may delay the start of the clinical trials but aims to improve the study's focus and relevance.

What is the significance of the phase 2a study in Tryp's development pipeline?

The phase 2a study is crucial as it evaluates the effectiveness of synthetic psilocybin in treating binge eating disorder, which could lead to advancements in their psilocybin-based therapies.