This production step is one of a series of steps in the project plan to manufacture batches of Tryp’s proprietary formulation of cGMP psilocybin to support the company’s clinical development and for the company’s upcoming clinical trials.
La Jolla, California--(Newsfile Corp. - February 16, 2021) - Tryp Therapeutics (CSE: TRYP) (“Tryp” or the “Company”) a pharmaceutical company focused on identifying and developing clinical-stage compounds for diseases with high unmet medical needs, announced that Albany Molecular Research (“AMRI”) has begun the process of manufacturing the 200g non-GMP demonstration batch of psilocybin. This production step is one of a series of steps in the project plan to manufacture batches of Tryp’s proprietary formulation of cGMP psilocybin to support the company’s clinical development and for the company’s upcoming clinical trials.
“AMRI is proud to support Tryp Therapeutics in their mission to address diseases with highly unmet needs through the rapid development and scale-up of a novel process to advance Psilocybin into human clinical trials,” said Christopher Conway, president, AMRI. “We are leveraging our core expertise in process development and cGMP manufacturing to help progress Tryp’s clinical pipeline.”
Larry Norder, Vice President, Manufacturing states, “We are pleased with the schedule and progress of our proprietary psilocybin development program with our partner, AMRI. In addition to process development for manufacturing psilocybin, AMRI is also managing compliance with regulations inherent with controlled substances. This compliance is mission critical but often not given sufficient priority in drug development programs.”
About Tryp Therapeutics:
Tryp Therapeutics is a pharmaceutical company focused on developing compounds with known activity and/or safety profiles for the treatment of rare diseases and other diseases with high unmet medical needs. Tryp’s psilocybin-for-neuropsychiatric disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States.
In addition to its PFN™ Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for Orphan Drug status.
About AMRI
AMRI, a contract research development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in discovery, development, analytical services, and API and drug product manufacturing. www.amriglobal.com
Contact:
For inquiries, please contact us at:
TRYP Investor Relations
T: 1-833-811-TRYP (8797)
E: investors@tryptherapeutics.com
W: www.tryptherapeutics.com
Forward-Looking Information
Certain information in this news release, including statements relating to the anticipated closing date of the Placement, 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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