Tryp Therapeutics Breaks New Grounds in Investigational Drugs

Congress established the Breakthrough Therapy designation in July 2012, allowing biotechnology and pharmaceutical companies to accelerate the examination of investigational medications.

FREMONT, CA: Congress established the Breakthrough Therapy designation in July 2012, which allows biotechnology and pharmaceutical companies to accelerate the examination of investigational medications that may have treatment advantages over current therapies for difficult-to-treat diseases. Gazyva, a drug used in conjunction with chlorambucil for patients with chronic lymphocytic leukemia, became the first breakthrough therapy approved by the FDA in November 2013. Numerous medications have received the designation since then, with several achieving commercialization. The rising market of psychedelics, where businesses like Tryp Therapeutics are trying to offer relief for patients with chronic pain by designing evidence-based innovation in areas where today's approved drugs and therapies are ineffective, remains underrepresented on the FDA breakthrough therapy list and could make waves soon. COMPASS Pathways Plc, Mind Medicine Inc., ATAI Life Sciences N.V., and Cybin Inc. are among a small group of impressive organizations that are progressing or have already sophisticated psychedelic treatments into Phase 2 of the FDA clinical trial process.

Opportunity Beyond Mental Illness

Many psychedelics firms are relying on data (historical, contemporary, and anecdotal) that suggests psychedelics can help with mental illnesses and ailments. To mention a few mental illness targets, these indicators include post-traumatic stress disorder ("PTSD"), anxiety, attention deficit-hyperactivity disorder ("ADHD"), and several types of depression. These indications, notably depression, are attracting a lot of attention since they represent numerous people who want more effective medication or therapy with fewer adverse side effects than presently available.

While depression is a hot topic among psychedelic firms, Tryp Therapeutics is confident that psilocybin may be used to address a variety of other unmet needs, including chronic pain and certain eating disorders. As part of Tryp's Psilocybin-for-Neuropsychiatric Disorders, or PFN, program, the San Diego-based business has established an experienced management team and a group of world-class advisers to give their experience in researching new medication candidates for chronic pain and eating disorders. For its Phase 2a clinical studies, Tryp uses its TRP-8802 product, a conventional oral form of synthetic psilocybin, to prove its efficacy throughout many indications.