Acurx Pharmaceuticals Inc (NASDAQ: ACXP) (FRA: 3ZO0) surged considerably on Mar. 10 following the announcement of a new clinical trial program for its lead drug, ibezapolstat.
Shares climbed by more than 29 per cent during regular trading hours, opening at US$2.09, hitting a high of US$2.99 and closing at US$2.53. They last closed at US$1.96, building on previous momentum from last week when stock was trading for US$1.35.
Investors rallied behind the news, which highlights progress in combating recurrent Clostridioides difficile infection (CDI). This stubborn bacterial issue causes severe diarrhea and affects over 500,000 Americans yearly. It is a high-unmet-need area due to a lack of efficacious treatments.
This development underscores the urgent need for innovative antibiotics amid growing antimicrobial resistance, where overuse of existing drugs fuels superbugs.
Study specifics and Ibezapolstat’s importance
Acurx has launched a pilot trial targeting patients with multiply-recurrent CDI. This is defined as at least three episodes in the past 12 months after standard antibiotic treatments like vancomycin or fidaxomicin have failed.
The study enrolls up to 20 participants and tests ibezapolstat’s ability to both cure the infection and prevent recurrence using a single agent rather than traditional multi-step regimens with unfavourable success rates. It could potentially become a game-changer in antibiotic therapy.
Ibezapolstat works as a new kind of antibiotic that blocks a specific enzyme (called DNA polymerase IIIC) needed by harmful Gram-positive bacteria like C. difficile to copy their DNA and multiply, essentially. Unlike broad-spectrum antibiotics that disrupt the microbiome and raise recurrence risks to 17 to 40 per cent, this drug promotes beneficial bacteria regrowth and adjusts bile acids for better gut defence, as explained by Acurx.
The trial will commence by the end of this month with the first patient expected to be dosed in Q4. It will pave the way for a larger Phase 3 study. Acurx aims for FDA approval, emphasizing ibezapolstat’s edge over other options requiring therapeutics for both treatment and prevention.
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
Building momentum in a challenging sector
This program — a small, exploratory, open-label pilot trial — extends Acurx’s Phase 2 successes where ibezapolstat achieved a 96 per cent clinical cure rate and 100 per cent sustained cure with no recurrences in 26 patients.
Founded in 2017 and based in New York, Acurx focuses on antibiotics for tough infections. For ibezapolstat, the biopharma operator holds FDA Fast Track and Qualified Infectious Disease Product designations.
The broader antibiotics sector grapples with resistance driven by inappropriate prescribing. Furthermore, CDI ranks as an urgent CDC threat, with global cases rising due to overuse across human and animal health.
Acurx’s work addresses this by developing targeted therapies, potentially reducing reliance on last-resort drugs and curbing resistance spread.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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