Acurx Is Vying for Standard of Care in Treating Primary and Recurrent C. diff

On the Heels of a Successful Phase 2a Trial, Acurx is Looking to Post Topline 

Results from a Muti-Center Phase 2b Trial by Mid-Year – The Results Could be Game-Changing

C. diff is a life-threatening bacterial infection that causes diarrhea and colitis, which is the inflammation of the colon. Approximately 600,000 are diagnosed with C. diff each year in the United States and it causes approximately 55 deaths a day. In the elderly population, 1 in 11 individuals over the age of 65 die within the month after being infected. The infection has a high recurrent rate, about 1 in 6 patients who get C. diff will get it again within 2-8 weeks. 

The current treatment for C. diff is vancomycin, an antibiotic that is typically prescribed for serious pathogenic infections. While the drug is safe and has proven successful, the antibiotic has been on the market for 65 years and its effectiveness has been steadily declining as more and more bacteria have become resistant to it, consistent with the path of virtually all other antibiotics over time.  

Understanding the need for a new antibiotic to treat C. diff, Acurx Pharmaceuticals ACXP is developing ibezapolstat, a novel first-in-class antibiotic currently in mid-stage clinical testing. It has been given Fast Track designation by the FDA and has been designated by the FDA as a Qualified Infectious Disease Product (QIDP), which grants priority review by the FDA and provides an additional five years of market exclusivity upon approval. The CDC acknowledges an ”urgent need” for new antibiotics to treat C. diff.

During the Phase 2a clinical trial, 100% of the first 10 patients were clinically cured of C. diff and did not have a recurrent infection within a 28-day period after the end of treatment with no safety concerns. Because of these strong results, the Scientific Advisory Board recommended that the trial be stopped early for success. 

The current standard of care, vancomycin, has an average clinical cure rate of 80% with a 30% chance of recurrent infection. In comparison, ibezapolstat would be a far more suitable drug with a higher success rate if current data holds in late-stage development. Acurx is expecting similarly strong results for their Phase 2b clinical trial. The company is expected to release topline results by mid-2023 if the FDA agrees with the company’s plan for an interim analysis. 

If the trials continue to be a success and ibezapolstat demonstrates statistical noninferiority compared to vancomycin in curing primary C. diff, it could win FDA approval and be used as first line therapy. But of equal, or even greater, importance are the results being shown in preventing recurrence -- the major cause of C. diff morbidity and mortality, and the principal contributor to C. diff’s $4.5 billion annual cost to the US healthcare system.

Being able to reduce or eliminate recurrence would be a game-changing development in treating an infection that affects so many individuals, especially amid rising bacterial resistance to vancomycin. 

Ibezapolstat’s potential game-changing status would be further assured if it scores well in two exploratory endpoints in the current Phase 2b trial – the number of disease-free patients at days 60 and 90 (two time points not included on any product labeled for C. diff.) and if it continues to demonstrate restoration of the healthy microbiome of C. diff patients during the treatment process.

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