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atai Life Sciences announces FDA Investigational New Drug (IND) Clearance for PCN-101 R-ketamine Program
• Enables expansion of PCN-101 clinical development to the U.S. • atai plans to initiate clinical drug-drug interaction (DDI) study in early 2022 to assess
About this update from Ataibeckley Inc.
[{"type":"text","content":"• Enables expansion of PCN-101 clinical development to the U.S. • atai plans to initiate clinical drug-drug interaction (DDI) study in early 2022 to assess pharmacokinetics of PCN-101 when used concurrently with other drugs • DDI trial will complement existing Phase 2a trial in treatment-resistant depression (TRD) recently initiated in Europe NEW YORK, Jan. 12, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the U.S. Food and Drug Administration (FDA) has given Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). atai plans to initiate the study early this year through its platform company Perception Neuroscience. The unique properties of PCN-101 could offer a differentiated profile to currently available antidepressants and address key patient needs, including the potential of rapid action and anti-suicidal effect. Rapid onset of action is particularly important in this patient population, but frontline selective serotonin reuptake inhibitors (SSRIs) can take up to 12 weeks before providing maximal benefit, while suicidality affects as much as 30% of treatment-resistant depression (TRD) patients at least once during their lifetime.1-3 In preclinical animal models of depressive behavior, R-ketamine has demonstrated the potential to offer longer durability and a potentially more favorable safety and tolerability profile than S-ketamine, which could enable the potential for at-home use.4,5 In addition, a third-party, open-label study observed a rapid, durable antidepressant response and limited dissociative side effects in patients with TRD after a single intravenous dose of another formulation of R-ketamine.6 “We see great promise in PCN-101 as a potentially rapid-acting anti-depressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use,” said Florian Brand, CEO and Co-Founder of atai Life Sciences. “With today’s IND clearance, we are excited to continue assessing the therapeutic potential of PCN-101 in the U.S., where, like elsewhere in the world, many patients struggle with treatment-resistant depression and desperately need innovative therapeutic options.” “TRD represents a large percenta...