Monopar Therapeutics Inc. announced completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer (OPC). This is an indication for which there is currently no FDA-approved preventative or treatment. The interim analysis included the first approximately 50% of the total planned patients to be enrolled.

It was conducted by an independent Data Safety Monitoring Board (DSMB), which informed the Company that the trial did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. The DSMB also reported that there were no safety concerns attributed to Validive. Based on not meeting the pre-specified efficacy threshold, Monopar announced that it will be discontinuing the study along with the active development of Validive.

Monopar also noted that it has sufficient funds to support its currently planned activities further beyond the first quarter of 2024.