Atai Life Sciences (NASDAQ: ATAI) announced results from Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). The small study seemed to deliver positive results, but it also looks as if Atai needs a partner before moving forward with the drug.
The study enrolled 16 healthy volunteers, each into one of four sequences of administration. The Phase 1 open-label, 4-period crossover study assessed the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101 delivered intravenously.
The study was designed to inform dosing regimens with the goal of creating an at-home use of ketamine versus going to a clinic for an IV treatment.
Positive Results
Atai said in its statement that the pharmacokinetic (PK) analysis indicated that 120mg of PCN-101 delivered SQ resulted in an approximate doubling of drug exposure (AUC) while maintaining approximately the same maximum concentration (Cmax) as the 60mg IV dose. It was generally well-tolerated with no serious adverse events reported.
At the 60mg IV dose, rates of sedation and dissociation were consistent with prior studies of PCN-101 at this dose-level. Encouragingly, at the highest SQ dose of 120mg, rates of sedation (defined as MOAA/S1 score <5) and dissociation (defined as CADSS2 total score >4 and change from baseline >0) were each 14%.
Spravato Comparisons
Atai said, “While recognizing the limitations of this small bridging study and cross-trial comparisons, this safety and tolerability profile compares favorably to that of Spravato, for which rates of sedation and dissociation have been reported to be in the ranges of 50-61% and 61-69%3, respectively, in prior studies. In addition, rates of sedation and dissociation were similar to those seen in the placebo arms of both the prior Phase 2 study of PCN-101 and the Spravato clinical trials in depression. Collectively, we believe these data support the concept of at-home use of PCN-101 in future studies.”
It was the last line of the press release that stood out with Atai saying it continues to work with Perception Neuroscience to explore strategic partnership options. This indicated to investors that the company wasn’t able to support funding the study program.
Investors weren’t happy with this news. The stock opened at $1.77 on Tuesday when the results were announced, but closed down at $1.75. Trading was active with 1.3 million shares, one of the largest days since mid-July. (Full Story)