In our latest Trade To Black Podcast, TDR Founder Shadd Dales and lead financial writer Benjamin A. Smith interview the founder of Apeiron Investment Group, Christian Angermayer. Aperion has deep a portfolio of early-stages companies in various industries, with atai Life Sciences N.V. (NASDAQ: ATAI) and COMPASS Pathways plc (NASDAQ: CMPS) being its crowing jewels in the psychedelics. Christian gives his perspective on the latest readout on Phase 2a trial compound PCN-101, which recently moved atai’s stock price, and gave his updated outlook on atai’s drug pipeline for 2023.
Atai Life Sciences subsidiary, Perception Neuroscience, is developing PCN-101 (R-ketamine) for the treatment of treatment-resistant depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, acting on the same receptors as ketamine in the brain to produce a similar effect.
Pre-clinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NMDA receptor and potentially a more favorable safety and tolerability profile.
On January 6, results from the Phase 2a clinical trial were announced. While PCN-101 was generally well-tolerated with rates of sedation and dissociation comparable to placebo, certain primary and secondary endpoints fell short of expectations. In this podcast, Christian Angermayer provides additional context on what he deems a “mixed” result.
While the market reacted to the headline, the purposes of a Phase 2a trial is to evaluate an effective dosing range and safety of a new drug or drug combination for a particular indication. Thus, variability of these small-scale patient results is not uncommon. The follow-on Phase IIb study (assuming there is a follow-on) will provide better confirmation of the drug’s true efficacy, as it will involve more patients at an optimized dosage. From there, greater conclusions about the drug’s effectiveness can be made.
As well, Christian explains how atai Life Sciences maintains a deep drug development portfolio able to withstand readout variability along the way. As at the end of September 30, 2022, the company ended their fiscal third quarter with quarter with $304M in cash, which combined with the non-dilutive funding facility from Hercules, provides a financial runway into 2025.
To view our previous atai Life Sciences focused interview with Christian Angermayer, click here.