Acurx Pharmaceuticals, a clinical-stage biopharmaceutical company at the forefront of developing a groundbreaking class of small molecule antibiotics targeting resilient bacterial infections, unveiled promising efficacy findings today stemming from the Phase 2 clinical trial of ibezapolstat in combatting C. difficile Infection (CDI). In the wake of this announcement, Acurx Pharmaceuticals’ stock has experienced a notable downturn, contrasting with its prior closing price of $5.07.
At the time of this publication, Acurx Pharmaceuticals Inc stock (ACPX) has witnessed a decline.
Acurx Pharmaceuticals Inc
Current Price: $3.59
Change : -1.48
Change (%): (-29.19%)
Source: Tomorrow Events Market Data
The amalgamated results of Phase 2 trials demonstrated an impressive Clinical Cure rate of 96% in CDI patients, encompassing 25 out of 26 participants. This included a 100% cure rate for 10 out of 10 patients in Phase 2a within the Modified Intent to Treat Population, and an impressive 94% for 15 out of 16 patients in Phase 2b within the Per Protocol Population, who achieved Clinical Cure during their treatment with ibezapolstat.
Ibezapolstat proved to be exceptionally well-tolerated, with only three patients experiencing mild adverse events, each judged by the blinded investigator to be linked to the drug. These events were predominantly gastrointestinal in nature and spontaneously resolved without the need for intervention. Notably, there were no instances of drug-related treatment withdrawals or any serious adverse events attributed to the drug.
In the Phase 2b vancomycin control arm, a clinical cure was observed in all 14 patients. Acurx Pharmaceuticals maintains a high level of confidence in the potential of ibezapolstat, backed by the pooled Phase 2 clinical cure rate of 96% and the historical cure rate of vancomycin, which stands at around 81% (Vancocin® Prescribing Information, January 2021). The company anticipates demonstrating the non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, aligning with the FDA’s pertinent Guidance for Industry, as of October 2022.
Acurx Pharmaceuticals’ strides in developing a novel class of antibiotics offer a promising outlook in the battle against challenging bacterial infections. The results from the Phase 2 clinical trial of ibezapolstat signal a potential breakthrough in the treatment of C. difficile Infection, with an impressive 96% Clinical Cure rate. As the company advances towards Phase 3 trials, stakeholders are keenly watching for further developments in this groundbreaking endeavor.