Monopar Therapeutics Shelves Development Of Validive For Radiation Therapy-Related Complication

Monopar Therapeutics Inc MNPR completed 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 for oropharyngeal cancer (OPC).
The interim analysis included the first approximately 50% of the total planned patients to be enrolled.
The independent Data Safety Monitoring Board (DSMB) informed that the trial did not meet the pre-defined threshold for the 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.
Monopar will be discontinuing the study along with the active development of Validive.
"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 to advance our Phase 1b camsirubicin clinical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes," said Chandler Robinson, CEO.
Monopar's Cash, cash equivalents, and short-term investments of $13.1 million are sufficient to provide a cash runway into Q1 of 2024.
Last month, the company opened enrollment for the fifth dose level cohort in the open-label Phase 1b camsirubicin Maximum Tolerated Dose trial for advanced soft tissue sarcoma, a diverse type of cancer that typically develops in the body's connective tissue.
Price Action: MNPR shares are down 52% at $1.43 on the last check Tuesday.

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