Atai Life Sciences: FDA Grants Investigational New Drug to PCN-101 R-ketamine Program
12 January 2022 - 11:55PM
Dow Jones News
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)
Copyright (c) 2022 Dow Jones & Company, Inc.
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