STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a $15 million market cap biopharmaceutical company advancing a new class of antibiotics, received positive feedback from the European Medicines Agency (EMA) regarding its lead antibiotic candidate, ibezapolstat. While the stock has declined over 77% in the past year, according to InvestingPro data, it has shown recent momentum with a 9% gain year-to-date. The EMA's Scientific Advice Procedure indicated that Acurx's clinical, non-clinical, and Chemistry Manufacturing and Controls (CMC) data package is sufficient to progress ibezapolstat into Phase 3 trials for Clostridioides difficile Infection (CDI).
This development follows Acurx's successful End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), where the company achieved consensus on the readiness for Phase 3 trials. The EMA's guidance complements the FDA's feedback, providing Acurx with a comprehensive roadmap for its international Phase 3 registration program. The company also plans to seek regulatory advice to initiate clinical trials in Japan, Canada, and the United Kingdom (TADAWUL:4280).
The Phase 3 program will include two pivotal trials designed as non-inferiority studies against vancomycin, a current standard-of-care treatment for CDI. The trials will assess the efficacy of ibezapolstat in achieving clinical cure and its potential impact on reducing CDI recurrence. Analysts maintain optimism about the company's prospects, with price targets ranging from $10 to $12 per share, significantly above current trading levels.
Ibezapolstat, which has been granted FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation, represents a novel class of small molecule antibiotics targeting difficult-to-treat bacterial infections. Its unique mechanism of action involves inhibiting DNA polymerase IIIC, crucial for bacterial DNA replication.
The company's Phase 2 clinical trial data demonstrated a 96% clinical cure rate for ibezapolstat, with a favorable safety profile and no serious drug-related adverse events. The trial also investigated the impact of ibezapolstat on the gut microbiome and bile acid metabolism, suggesting potential advantages over vancomycin in preventing CDI recurrence.
The feedback from EMA is a significant step for Acurx as it prepares for the next phase of ibezapolstat's development and potential marketing authorization in the European Union. The company maintains a healthy current ratio of 1.8 and holds more cash than debt on its balance sheet, positioning it well for the upcoming trials. The information is based on a press release statement from Acurx Pharmaceuticals, Inc.For deeper insights into ACXP's financial health and growth prospects, including additional ProTips and comprehensive analysis, visit InvestingPro, where you'll find detailed Pro Research Reports covering over 1,400 US stocks.
In other recent news, Acurx Pharmaceuticals has been making significant advancements in its clinical trials, particularly for ibezapolstat, a promising treatment for C. difficile infection. The company reported a net loss of $2.8 million for the third quarter of 2024, with cash reserves of $5.8 million. As part of its treasury strategy, Acurx has approved the purchase of up to $1 million in Bitcoin.
The company has also secured a new patent for ibezapolstat, extending its protection until June 2042. Plans are 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 recent developments in the company's ongoing efforts to bring novel treatments for infectious diseases to the market.
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