Debra Borchardt
Atai Life Sciences (Nasdaq: ATAI) released positive results from the Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine), but Atai might need 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, four-period crossover study assessed the safety, tolerability, and pharmacokinetic profile of 60 milligrams, 90 milligrams, and 120 milligrams of PCN-101 delivered subcutaneously as compared to 60 milligrams 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 analysis indicated that 120 milligrams of PCN-101 delivered subcutaneously resulted in an approximate doubling of drug exposure while maintaining approximately the same maximum concentration as the 60-milligram IV dose. It was generally well-tolerated with no serious adverse events reported.
At the 60-milligram IV dose, rates of sedation and dissociation were consistent with prior studies of PCN-101 at this dose-level. Encouragingly, at the highest subcutaneous dose, rates of sedation and dissociation were each 14%.
Spravato Comparisons
It’s unavoidable that studies of this nature will be compared to Spravato, which is an FDA-approved nasal spray for treatment-resistant depression with esketamine, a ketamine derivative, as its active ingredient.
“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%, respectively, in prior studies.,” Atai said. “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.”
In the last line of the press release, however, Atai said 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.
