PCN-101, a ketamine-based candidate for treatment-resistant depression being developed by Atai’s Perception Neuroscience, fell short in a Phase II trial.
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Perception Neuroscience, a subsidiary of atai Life Sciences, released data Friday that showed PCN-101, its ketamine-based candidate developed for treatment-resistant depression, fell short of expectations in Phase II.
atai’s stock fell over 40% Friday morning following the announcement.
PCN-101 demonstrated an overall positive safety profile and signals of efficacy at the two-week mark. Despite this, it did not meet the primary endpoint, defined as a statistically significant change from baseline in participants’ MADRS (Montgomery-Åsberg Depression Rating Scale) score at 24 hours compared to placebo.
The Phase IIa study included 102 patients who had previously failed at least two rounds of antidepressants. The trial included three arms, and patients received a single IV dose of either placebo or 30 mg or 60 mg of PCN-101 in addition to their existing treatment regimens.
PCN-101 was developed jointly by both Perception and Otsuka Pharmaceutical, a partnership that was forged in March of 2021.
PCN-101 is also known as R-Ketamine and was developed to be used in place of Spravato (S-ketamine), which has previously been approved by the FDA.
Spravato’s side effects include dissociation and significant sedation, and it is designed to only be administered to patients in a clinical setting.
atai had high hopes for the candidate. Just one month prior to these data, Srinivas Rao, co-founder and CSO of atai, told BioSpace that due to promising Phase I data, he believed PCN-101 had the potential to be an effective at-home treatment for treatment-resistant depression that “could be significant for patients, physicians and payers.”
atai has been largely considered a leader in psychedelic-based therapies for some time. Even so, 2022 was a tumultuous year for the company.
In its Q2 report, atai announced plans to drop three of its psychedelic-based candidates, leaving eight clinical-stage compounds in its pipeline. This was expected to buy it about a year of cash flow.
As for PCN-101, atai stated it would “further evaluate the...data in more detail over the next weeks and will work with [Perception] to explore next steps.” These next steps include seeking strategic partnership options, atai added, hinting at a new collaboration in the works.
