MNPR - Monopar stock crashes ~50% as Validive program gets axed after trial failure

2023-03-28 05:57:36 ET

Monopar Therapeutics' ( NASDAQ: MNPR ) is discontinuing the active development of Validive after the drug did not meet the required efficacy to prevent severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) in a phase 2b/3 trial called VOICE.

SOM is condition in which inflammation and ulcers develop in the mouth. It is usually a complication of radiation therapy and chemotherapy.

The company said an interim analysis included about 50% of the total planned patients.

An independent Data Safety Monitoring Board (DSMB) conducted the analysis and told the company that the study did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo.

Monopar said it will discontinue the trial and the active development of Validive.

The company noted that it has sufficient funds to support its activities beyond Q1 2024.

"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 Monopar's CEO Chandler Robinson.

In November 2022, the company had reported data from an ongoing phase 1b trial of camsirubicin in patients with advanced soft tissue sarcoma.

MNPR -49.31% to $1.47 premarket March 28

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