TRYP THERAPEUTICS ANNOUNCES RESULTS OF FIRST PATIENT DOSED IN ITS PHASE II CLINICAL TRIAL FOR THE TREATMENT OF BINGE EATING DISORDER

Rhea-AI Summary

Tryp Therapeutics (CSE: TRYP; OTCQB: TRYPF) announced initial positive results from its Phase II S.T.O.P. trial, aimed at treating Binge Eating Disorder (BED) with psilocybin-based compound TRP-8802. The first patient dosed showed significant behavioral improvements, including reduced anxiety and weight loss over four weeks after therapy. No drug-related adverse events were reported. The company plans to further investigate TRP-8803, a more advanced formulation intended for BED and other neuropsychiatric disorders. The interim CEO expressed optimism about the results and future studies.

Positive

• Initial patient showed reduced anxiety and improved self-image after treatment.
• Significant weight loss observed after four weeks.
• No drug-related adverse events reported during the study.
• Potential for TRP-8803 to enhance treatment efficacy in future trials.

Negative

• None.

Initial data readout supports the potential effectiveness of psilocybin and psilocybin-related compounds for the treatment of Binge Eating Disorder

SAN DIEGO, June 9, 2022 /PRNewswire/ -- Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) ("Tryp" or the "Company"), a clinical-stage biotechnology company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today the initial data readout for the first patient dosed in its Phase II S.T.O.P. (Study of the Treatment of Overeating utilizing Psilocybin) trial. In collaboration with the University of Florida. The STOP trial is evaluating TRP-8802 in patients with Binge Eating Disorder ("BED"). and represents the first use of psilocybin in conjunction with psychotherapy as a therapeutic intervention in patients with BED.

Beginning immediately following the post-dosing integration session with the trial's psychotherapists and persisting throughout the four-week time period post-dosing, the first patient in the STOP trial exhibited reduced overall anxiety; reduced anxiety around food; reduced compulsion to overeat; and improved self-image and confidence. These positive changes in behavior translated to significant weight loss at four weeks. The observed behavioral improvements are consistent with those described in other clinical studies examining the clinical benefit of psilocybin as a therapeutic intervention in neuro-psychiatric disorders. In addition, it is important to note there were no drug-related adverse events observed during the 4-week period following dosing of TRP-8802. Pursuant to the STOP trial protocol, patients will be monitored for an additional eight weeks post-dosing,

Jim Gilligan, Tryp's Interim CEO and Chief Scientific Officer, stated, "While we are mindful to not draw too many conclusions from the first patient at four weeks, we are excited with the results to date and look forward to the potential replication of these results in additional patients. Based on our understanding of psychotherapy in BED patients and our discussions with our colleagues at the University of Florida, we believe that the improvements witnessed in this patient following a single intervention with TRP-8802 in combination with tailored psychotherapy are on par with what might be possible in 12 months of extensive psychotherapy alone."

TRP-8802 is the predecessor to Tryp's lead psilocybin-based drug candidate, TRP-8803. TRP-8803 includes a unique formulation and delivery system and is designed to enhance the positive effects of psilocybin and psilocybin-related compounds, while markedly reducing the limitations of psilocybin dosed through other routes of administration. In combination with psychotherapy, TRP-8803 is intended to serve as a treatment for certain neuropsychiatric disorders including BED. Tryp is utilizing TRP-8802 to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders in early-stage trials. If initial efficacy is shown, TRP-8803 will be studied in future trials.

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 in the United States; treatments to date have not been effective.

About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology 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 II trial for the treatment of binge eating disorder at the University of Florida and recently announced an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP-8802 for fibromyalgia. TRP-8803 is a proprietary psilocybin-based product that uses a novel formulation and route of administration to potentially improve efficacy, safety 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:
Francesca DeMauro/ Anu Kher
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.

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SOURCE Tryp Therapeutics

FAQ

What are the initial results of Tryp Therapeutics' Phase II clinical trial for BED?

The initial results indicate significant behavioral improvements, including reduced anxiety, compulsion to overeat, and notable weight loss in the first patient dosed with TRP-8802.

What is the purpose of the S.T.O.P. trial conducted by Tryp Therapeutics?

The S.T.O.P. trial is designed to evaluate the effectiveness of psilocybin (TRP-8802) in treating Binge Eating Disorder in conjunction with psychotherapy.

What is the next step for Tryp Therapeutics following the trial?

Based on the initial positive results, Tryp intends to proceed with further studies of TRP-8803, which utilizes a unique formulation aimed at enhancing treatment effects.

What does the data indicate about the safety of TRP-8802?

No drug-related adverse events were observed during the four-week follow-up period after dosing TRP-8802.