SAN DIEGO Tryp Therapeutics (CSE:TRYP; OTCQB:TRYPF), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs through accelerated regulatory pathways, announced today an agreement with Calvert Labs to design and execute exploratory studies related to Tryp’s Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program.
Calvert Labs, an Altasciences company, has a proven track record of executing FDA-approved studies across a broad range of therapeutic indications. The studies will focus on generating toxicology and blood exposure level data for Tryp’s proprietary, psilocybin-based formulation, TRP-8803, while strengthening Tryp’s intellectual property portfolio for the drug product. The completion of these studies will also provide regulatory support for the Company’s novel methods for the formulation, delivery, and dosing of its products in future clinical studies.
Under the terms of the agreement, Calvert Labs will perform preclinical bridging studies required for TRP-8803 prior to initiating clinical studies with the novel drug product. Tryp will subsequently work with Altasciences to perform Clinical Pharmacology studies in healthy, volunteer patients with TRP-8803. These studies will enable the use of TRP-8803 in Tryp’s planned Phase 2b clinical trials for chronic pain and eating disorder indications.
As part of the studies, Tryp has also entered into an agreement with Gad Consulting Services to advise on certain aspects of the studies performed by Calvert Labs. Gad Consulting Services is an internationally recognized toxicology consulting practice serving the pharmaceutical industry in the areas of preclinical and early clinical evaluation, safety assessment, and risk assessment.
“This partnership marks an important milestone for us as we continue to build momentum towards our Phase 2b clinical studies with our proprietary TRP-8803 formulation,” said Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp Therapeutics. “Calvert Labs and Gad Consulting Services are ideally suited to perform these important studies given their international expertise in toxicology. Our work with these organizations and with Altasciences will accelerate our time into the clinic with TRP-8803.”
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.
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