PsyBio Therapeutics Corp. (TSXV: PSYB / OTCQB: PSYBF), an intellectual property driven biotechnology company focused upon discovery and development of novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announces that it has received government sanctioned, formal written approval to manufacture PsyBio’s proprietary biosynthetic tryptamines.
“PsyBio has worked diligently to achieve formal written approval to allow full scale manufacturing of its proprietary biosynthetic tryptamines, including our lead compound PsyBio-11142, which is the penultimate step in moving that first psycho-targeted therapeutic candidate into human clinical trials with the goal to potentially improve mental and neurological health. This approval has taken over two years to achieve and stands as a critically important milestone that was necessary in order to move forward. This authorization paves the way towards PsyBio conducting its first clinical trial utilizing biosynthetic tryptamines and is expected to further our understanding of these molecules as therapeutic agents.”
Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer and Chief Scientific Officer.
The authorization allows PsyBio to initiate the manufacturing process leading to the production of a sufficient quantity biosynthetic tryptamine for testing and human clinical trials. This announcement demonstrates PsyBio’s commitment to scientific advancements.
“PsyBio has demonstrated the dedication and due diligence that led to this first of its kind authorization to produce biosynthetic tryptamines through our proprietary process. This approval further demonstrates our leadership within the industry as we continue to develop biosynthetic psycho-targeted therapeutic candidates,” stated Evan Levine, PsyBio’s Chief Executive Officer. “With this approval, PsyBio will further establish its leadership role as a premier biotechnology company with its first compound advancing towards clinical phase, human trial evaluation.”
About PsyBio Therapeutics Corp.
PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.