The positive DSMB recommendation follows the successful completion of the third cohort and is based on encouraging top-line safety data demonstrating that CMND-100 was well tolerated with no serious adverse events reported. These results reinforce the favorable safety and tolerability profile observed in previous cohorts.
As a result, the Company will now proceed to the fourth cohort of the trial and will increase the tested dose of its proprietary drug candidate CMND-100 to 160mg.
The Phase I/IIa clinical trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100, the Company's proprietary non-hallucinogenic MEAI-based oral drug candidate, in patients with moderate to severe AUD.
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