STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a clinical-stage biopharmaceutical company with a market capitalization of $12.67 million, is gearing up for international Phase 3 clinical trials of its lead candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI). According to InvestingPro data, despite the stock trading near its 52-week low at $0.75, analysts maintain price targets between $10-12, suggesting significant potential upside. The company has recently received positive feedback from the U.S. Food and Drug Administration (FDA) and is awaiting final advice from the European Medicines Agency (EMA) for the upcoming trials.
The FDA has provided Acurx with written confirmation regarding the acceptability of its Chemistry Manufacturing and Controls (CMC) plan and data package for Phase 3 readiness. Similarly, the company has initiated the Scientific Advice procedure with the EMA and expects to receive written advice in the next few weeks. These communications follow a successful End of Phase 2 meeting with the FDA, where key elements for the Phase 3 trials were agreed upon, including protocol design, patient population, and endpoints.
The planned Phase 3 trials will be non-inferiority studies comparing ibezapolstat to the standard-of-care vancomycin. An estimated 450 subjects will be enrolled and randomized to determine the clinical cure of CDI after a 10-day oral treatment and assess the potential effect on reducing CDI recurrence.
Acurx is also discussing pediatric development plans for ibezapolstat with health authorities in both the U.S. and EU, as required by regulatory standards. Additionally, the company is preparing to seek regulatory guidance to initiate clinical trials in Japan, Canada, and the United Kingdom (TADAWUL:4280).
The Phase 2 clinical trials of ibezapolstat have shown promising results, with a 96% clinical cure rate observed in patients with CDI, and a favorable safety profile with no serious drug-related adverse events reported. While InvestingPro analysis indicates the company maintains a healthy balance sheet with more cash than debt, investors should note that the company is not yet profitable, with a return on assets of -250.15%. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro's detailed research reports, available for over 1,400 US stocks. The drug has been granted FDA QIDP and Fast-Track Designation, and Acurx has received SME designation by the EMA.
Ibezapolstat, a novel DNA polymerase IIIC inhibitor, aims to treat bacterial infections while maintaining a healthy gut microbiome. It has shown the potential to alter bile acid metabolism, which may reduce the likelihood of CDI recurrence. With the stock showing a beta of -1.85, InvestingPro data suggests ACXP often moves counter to broader market trends, potentially offering portfolio diversification benefits.
This update is based on information provided in a press release statement from Acurx Pharmaceuticals.
In other recent news, Acurx Pharmaceuticals has reported a net loss of $2.8 million for the third quarter of 2024, with cash reserves of $5.8 million. The company has also decided to diversify its treasury strategy, approving the purchase of up to $1 million in Bitcoin to serve as a treasury reserve asset. This move comes as part of a broader diversification strategy and does not signify a shift away from their primary pharmaceutical endeavors. In terms of recent developments, Acurx Pharmaceuticals has been making significant strides in clinical trials, particularly for ibezapolstat, a promising treatment for C. difficile infection. The company also secured a new patent for ibezapolstat, extending its protection until June 2042. Plans are also underway for Acurx to begin regulatory discussions with the European Medicines Agency in late 2024 or early 2025. The company is also advancing a stool sample-based diagnostic tool for predicting C. difficile reinfection risk. In terms of future trials, Acurx is preparing for Phase III trials for ibezapolstat, which are planned to include 150 sites and 900 patients. These are the latest developments in the company's ongoing efforts to bring novel treatments for infectious diseases to the market.
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