atai Life Sciences N.V. (NASDAQ: ATAI) Announce Q3 2021 Results And Initiation of PCN’101 Study In TRD

atai Life Sciences N.V. (NASDAQ: ATAI) has announced its Q3 2021 financial results for the quarter ending September 30, 2021, and offered a corporate update.

atai developing treatment-resistant depression therapies 

Following the company’s IPO in June, it has witnessed considerable momentum. Currently, atai has 11 therapeutics programs under development, and it is on course to attain its mission of treating mental health disorders.

CEO and Co-Founder Florian Brand said, “In response to the heterogeneity of the mental health patient population, we are developing a pharmacologically diverse array of treatments. We intend to support these treatments with innovative digital therapeutics and robust insights from our multi-modal data approach. Our ultimate goal is to tailor our treatments to individual patient needs by using a diverse set of biomarkers. We anticipate further growth of our drug development pipeline and our enabling technologies through our ‘buy and build’ approach and will remain highly active in business development.”

Positive COMPASS results  and initiation of PCN-101 study 

The company announced encouraging COMPASS results from the phase 2b doses controlled study of COMP360 psilocybin therapy in treatment-resistant depression. The study met the primary endpoint with a 6.6 point reduction in the MADRS total score from baseline to three weeks.  Also, in September, Perception Neuroscience commenced Phase 2 study of PCN-101 evaluating safety, doses response, action duration, and efficacy in TRD patients. PCN101 is a parenteral R-Ketamine formulation under development as a rapid-acting antidepressant.

Florian said, “We recently initiated two new clinical trials: a Phase 2a trial with PCN-101 (R-ketamine) for treatment-resistant depression and a Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In terms of clinical readouts, just last week we saw positive Phase 2b data from COMPASS Pathways, the first company we funded to rigorously research the potential of psychedelics. This clinical trial demonstrated the rapid onset of effect, large effect size, and durability of COMP360 (a proprietary synthetic formulation of psilocybin) in treatment-resistant depression. We expect another important clinical readout before the end of the year for RL-007 in cognitive impairment associated with schizophrenia.”