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Perception Neuroscience Reports PCN-101 (R-Ketamine) Demonstrates Tolerability in Phase 1 Single Ascending Dose Study

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February 19, 2021

Perception Neuroscience announced positive data from its first Phase 1 clinical study* demonstrating the safety and tolerability of PCN-101 (R-ketamine).

R-ketamine is a stereoisomer of ketamine that is being developed for therapeutic treatment of psychiatric illnesses such as Treatment Resistant Depression (TRD).

The two-stage study first evaluated the safety, tolerability and pharmacokinetics of single ascending doses of PCN-101** in 58 healthy adult volunteers, administered via intravenous infusion and compared to placebo. In this study, PCN-101 was safe and well-tolerated at all doses up to 150 mg, the highest dose tested. There were no serious adverse events reported. The pharmacokinetics of PCN-101 in plasma were approximately dose-proportional.

The second stage of the study compared the relative safety and tolerability of PCN-101 to that of S-ketamine. The results demonstrated that PCN-101 required substantially higher doses to induce similar perceptual changes than S-ketamine.

“We are excited by the Phase 1 results that support the hypothesis that PCN-101 can be developed as a rapidly acting antidepressant with the potential for at-home use,” said Terence Kelly, PhD, CEO of Perception Neuroscience. “The upcoming Phase 2 proof-of-concept trial in patients with Treatment Resistant Depression is the next important step in demonstrating the full potential of PCN-101.”

Dr. Kelly also announced that Perception has secured additional funding to enable the Phase 2a proof-of-concept study of PCN-101. This study is expected to initiate in the second quarter of 2021. The financing round was led by atai Life Sciences.

“The success of Perception’s Phase 1 clinical study leads us to believe that PCN-101 has the potential to offer a highly differentiated profile from current treatment options,” said Florian Brand, CEO & Co-founder of atai Life Sciences. “We are thrilled by this success, with these results paving the way for our upcoming Phase 2 clinical study. The incredible work of the teams at Perception and atai, combined with the support of our investors, provides progress in our mission of delivering optionality to patients who suffer from Treatment Resistant Depression.”

*Phase 1 Study: This was a Phase 1 single-center, randomized, placebo-controlled, double-blind single ascending dose study of the safety, tolerability and pharmacokinetics of PCN-101 that included a subsequent relative safety comparison of PCN-101 and S-ketamine. Healthy subjects were administered a single 40-minute intravenous infusion of PCN-101 or placebo.

The safety and tolerability assessments included reported adverse events, changes in hematology, serum chemistry, vital signs, ECG, sedation, and the development of dissociative or perceptual changes.

**PCN-101: 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 (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical 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 NDMA receptor and potentially a more favorable safety and tolerability profile.

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