Mira Pharmaceuticals Launches Phase 1 Trial of Oral Ketamir-2 for Chemotherapy-Induced Neuropathic Pain
Mira Pharmaceuticals Inc. has announced the initiation of the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The company has also selected chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for its planned Phase 2a trial. The Phase 1 study is randomized, double-blind, and placebo-controlled, assessing the safety, tolerability, and pharmacokinetics of Ketamir-2. No serious or dose-limiting adverse events have been observed to date, and no clinically significant safety concerns have been reported. Results from the comprehensive pharmacokinetic analyses will be presented following unblinding. Ketamir-2 is a novel oral analog of ketamine developed to address limitations of current therapies and is being considered for further development in CIPN due to the lack of FDA-approved treatments for this condition.
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