- Tryp Therapeutics recently announced new agreements with Calvert Labs and Gad Consulting Services, the second in a series of upcoming bridging studies aimed at facilitating the advancement of TRP-8803 into Phase 2b clinical trials
- Calvert Labs will design and execute the exploratory studies, while Gad Consulting Services will advise on certain aspects of the studies Calvert Labs shall perform
- TRP-8803 and TRP-8802 are psilocybin-based products being evaluated under Tryp’s PFN program
- Tryp intends to use TRP-8802 in the Phase 2a clinical trials, while TRP-8803 will be used in Phase 2b clinical trials and beyond
The San Diego-based pharmaceutical company, Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF), has amply prepared for its Phase 2 clinical trials by leveraging high quality collaborations. For the Phase 2a studies, the company will work with the University of Michigan, the University of Florida, and Clinlogix, and to facilitate the advancement of TRP-8803 into Phase 2b clinical trials for chronic pain and eating disorders, respectfully. Tryp announced on July 7, a partnership with the University of Michigan as part of a series of upcoming bridging studies (https://ibn.fm/r71NY).
A little over a month later, Tryp announced on August 10 new agreements with Calvert Labs, an Altasciences company and preclinical contact research organization (“CRO”), and Gad Consulting Services (https://ibn.fm/X59p6) that constitute the second batch of the upcoming bridging studies.
As part of the agreement with Calvert Labs, the CRO will design and execute exploratory preclinical studies required for Tryp’s proprietary, psilocybin-based compound, TRP-8803, before initiating clinical studies with the novel drug product. The preclinical studies will entail generating toxicology and blood exposure level data for the flagship product.
Later, Tryp will work with Altasciences to perform clinical pharmacology studies in healthy, volunteer patients with TRP-8803, thus enabling the use of TRP-8803 in the planned Phase 2b clinical trials for chronic pain and eating disorder indications.
On its part, Gad Consulting Services, an internationally acclaimed toxicology consultant serving the pharmaceutical industry in the areas of preclinical and early clinical evaluation, safety assessment, and risk assessment, will advise on certain aspects of the studies Calvert Labs shall perform.
“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 Tryp Therapeutics President and Chief Science Officer Jim Gilligan, Ph.D. “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.”
The TRP-8803, along with TRP-8802, are the flagship psilocybin-based products for Tryp’s Psilocybin-for-Neuropsychiatric Disorders (“PFN”) program, which targets eating disorders such as binge eating disorder, hypothalamic obesity, and others, as well as chronic pain conditions, including fibromyalgia, phantom limb pain, complex regional pain syndrome, and others (https://ibn.fm/ESRgw).
Tryp intends to proceed directly into a Phase 2 clinical trial by leveraging preclinical and clinical data for the active pharmaceutical ingredients in TRP-8802 and TRP-8803. It has divvied up the Phase 2 clinical trials into Phase 2a and Phase 2b. Phase 2a trials will assess the efficacy and safety of TRP-8802, which is an oral form of the psilocybin-based compound, while Phase 2b trials will involve the use of TRP-8803, a formulation with a novel method of administration. Tryp will also use TRP-8803 for Phase 3 trials.
The bridging studies are expected to build momentum as the company gears towards these Phase 2b trials, in addition to helping strengthen Tryp’s intellectual property (“IP”) for the TRP-8803 drug product. Based on the July 7 announcement, more bridging studies could still be in the works.
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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