Tampa, FLA. – July 13, 2021 – Psilera Inc., a Florida-based biotechnology company, has entered a consulting contract with Worldwide Clinical Trials to ensure the pre-IND filing of its patent-pending dimethyltryptamine (DMT) patch. This collaboration aims to move forward with anticipated Phase 1b clinical trials testing safety and efficacy in humans in 2022.
The scope of work includes 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. Worldwide's team, known for its expertise in neurology, psychiatry, and regulatory affairs, will play a crucial role in this process.
Dr. Chris Witowski, Co-Founder and CEO of Psilera, expressed enthusiasm about the partnership, highlighting Worldwide's renowned expertise and its importance in advancing Psilera's next-generation mental health therapies.
Psilera has developed a comprehensive intellectual property portfolio, including transdermal drug delivery devices. This innovative method allows for the direct delivery of drugs into the bloodstream, reducing DMT metabolism and providing steady, sub-psychedelic dosages. This approach, combined with DMT's broad therapeutic potential, could lead to a revolutionary new line of psychiatric medicines.
Several preclinical studies have been completed with Psilera’s DMT patch, and efforts are underway to file an investigational new drug (IND) with the FDA in Q4 2021.
Psilera Inc. focuses on developing its proprietary neuromodulator pipeline to target central nervous system disorders, leveraging research strengths from the pharmaceutical and cannabis industries. Worldwide Clinical Trials, with over 2,000 professionals globally, is committed to advancing medical science and changing the experience of CROs for the better.
