Monopar Therapeutics’ (NASDAQ:MNPR) is discontinuing the energetic improvement of Validive after the drug didn’t meet the required efficacy to forestall extreme oral mucositis (SOM) in sufferers present process chemoradiotherapy (CRT) in a section 2b/3 trial referred to as VOICE.
SOM is situation wherein irritation and ulcers develop within the mouth. It’s normally a complication of radiation remedy and chemotherapy.
The corporate stated an interim evaluation included about 50% of the whole deliberate sufferers.
An unbiased Information Security Monitoring Board (DSMB) carried out the evaluation and instructed the corporate that the research didn’t meet the pre-defined threshold for efficacy of a 15% absolute distinction in SOM prevention between Validive and placebo.
Monopar stated it’s going to discontinue the trial and the energetic improvement of Validive.
The corporate famous that it has adequate funds to assist its actions past Q1 2024.
“Whereas we’re dissatisfied with the result of this research, we are actually targeted on re-deploying the monetary and human assets beforehand devoted to Validive as a way to advance our Section 1b camsirubicin medical trial and our MNPR-101 radiopharmaceutical program partnered with NorthStar Medical Radioisotopes,” said Monopar’s CEO Chandler Robinson.
In November 2022, the corporate had reported knowledge from an ongoing section 1b trial of camsirubicin in sufferers with superior smooth tissue sarcoma.
MNPR -49.31% to $1.47 premarket March 28
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