By Michael Dabaie

 

Atai Life Sciences N.V. said the U.S. Food and Drug Administration gave investigational new drug clearance to conduct a clinical drug-drug interaction study of PCN-101, or R-ketamine.

The clinical-stage biopharmaceutical company focused on mental health disorders plans to initiate the study early this year through its platform company Perception Neuroscience.

The DDI trial will complement an existing Phase 2a trial in treatment-resistant depression recently initiated in Europe.

The company said PCN-101 could offer a differentiated profile to currently available antidepressants and address patient needs including the potential of rapid action and anti-suicidal effect.

"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 Chief Executive Florian Brand.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

January 12, 2022 07:40 ET (12:40 GMT)

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