Result of interim analysis of phase IIb/III VOICE trial evaluating Validive for severe oral mucositis.- Monopar Therapeutics.
Monopar Therapeutics Inc. announced completion of a pre-specified interim analysis for its Validive Phase IIb/III 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.
“We are very grateful to the patients and investigators who participated in the VOICE trial. The Phase IIb/III VOICE trial was intended to further evaluate a novel treatment for SOM following the promising signals observed in a prior randomized, double-blinded Phase II study with OPC patients. While we are disappointed with the outcome of this study, we are now focused on re-deploying the financial and human resources previously dedicated to Validive in order to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
Monopar also noted that it has sufficient funds to support its currently planned activities further beyond the first quarter of 2024.
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