Tampa, FLA. (PRWEB) – July 13, 2021 – Psilera Inc., formerly Psilera Bioscience (“Psilera”), a Florida-based biotechnology company specializing in the clinical development of psychedelics and analogues, has entered a consulting contract with Worldwide Clinical Trials (“Worldwide”) the industry’s leading global, midsized, full-service contract research organization (CRO), to ensure the pre-IND filing of its patent-pending dimethyltryptamine (DMT) patch. This will enable the company to move forward with anticipated Phase 1b clinical trials testing safety and efficacy in humans in 2022.
The scope of work outlines the accrual of generated data and prior clinical results with DMT, a briefing protocol and study synopsis, and a consultative pre-IND meeting with the FDA. The team at Worldwide includes industry leaders in neurology, psychiatry, and regulatory affairs with proven experience in FDA guidance on psychedelic compounds.
“We look forward to working with the impressive team at Worldwide as this brings us another step closer to human trials.” said Dr. Chris Witowski, Co-Founder and CEO of Psilera. “Their expertise is world renowned, and we have no doubt that they will be a crucial partner for us in bringing forth Psilera’s next generation mental health therapies to future patients.”
Psilera has developed a comprehensive intellectual property portfolio including transdermal drug delivery devices. Transdermal administration can deliver drugs directly into the bloodstream and reduce DMT metabolism while providing steady, sub-psychedelic dosages. This innovative drug delivery method combined with DMT’s broad therapeutic potential could lead to a revolutionary new line of psychiatric medicines.
Several preclinical studies have been completed to date with Psilera’s DMT patch and work has begun to file an investigational new drug (IND) with the FDA in Q4 2021.
Psilera Inc. is a psychedelic-based biotechnology company developing its proprietary neuromodulator pipeline to target central nervous system disorders. Psilera leverages research strengths with executives from the pharmaceutical and cannabis industries to repurpose psychoactive natural products like DMT as building blocks for next generation therapies to improve mental health in the areas of mood, cognitive, and substance use disorders.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs 2,000+ professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia-Pacific. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval, and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology, and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit www.worldwide.com.