STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a biopharmaceutical company specializing in the development of new antibiotics, has announced the scheduling of an End of Phase 2 (EOP2) meeting with the FDA for late April 2024. This meeting will focus on the Phase 3 development plan for ibezapolstat, a treatment for C. difficile Infection (CDI). The company confirmed the submission of a pre-meeting briefing document to the FDA as required.
The EOP2 meeting follows the successful completion of the Phase 2 clinical trial for ibezapolstat and will provide Acurx with the opportunity to discuss the design and readiness of their Phase 3 program, which includes international clinical study sites. The FDA previously granted ibezapolstat Fast-Track and Qualified Infectious Disease Product (QIDP) designations, recognizing the need for new treatments for CDI.
Additionally, the European Medicines Agency (EMA) granted Small and Medium-sized Enterprise (SME) status to Acurx on February 15, 2024. This designation allows the company to benefit from fee reductions and support from the EMA for clinical trials and EU Marketing Authorization.
The Phase 2 clinical trial for ibezapolstat demonstrated a 96% cure rate in patients with CDI, indicating potential non-inferiority to the standard treatment, vancomycin. The trial also suggested ibezapolstat may reduce the likelihood of CDI recurrence compared to vancomycin, based on observed changes in bile acid metabolism and gut microbiota.
Ibezapolstat, a novel antibiotic, is the first in a new class of DNA polymerase IIIC inhibitors. It has been shown to maintain a healthy gut microbiome during treatment, which may contribute to its effectiveness against CDI.
The development of ibezapolstat is part of Acurx's broader strategy to create a new class of antibiotics targeting difficult-to-treat bacterial infections. The company's approach focuses on inhibiting DNA replication in Gram-positive bacteria, which includes pathogens like MRSA and VRE, in addition to CDI.
This news is based on a press release statement from Acurx Pharmaceuticals, Inc.
InvestingPro Insights
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), while advancing its clinical programs, presents a mixed financial landscape according to the latest data from InvestingPro. The company's market capitalization stands at a modest $44.75 million, reflecting the size and speculative nature of this biopharmaceutical venture. Despite the challenges often faced by companies in this sector, Acurx has managed to maintain a cash position that exceeds its debt, an important indicator of financial health and stability. This is particularly pertinent for investors considering the long and capital-intensive road to bringing new drugs to market.
Investors following ACXP have observed a significant return of 11.3% over the last week, potentially driven by positive sentiment surrounding its upcoming FDA meeting. However, it's worth noting that the stock has experienced volatility, with a 16.02% decrease over the last month, which may reflect the inherent risks associated with clinical-stage biopharmaceutical companies.
Furthermore, the company's stock price is currently trading at a high Price / Book multiple of 11.37, which could suggest that the market has high expectations for the company's asset value and future growth. This optimism may be tempered by the fact that analysts do not anticipate the company will be profitable this year, underlining the speculative nature of investing in ACXP at this stage of its development.
For those looking to delve deeper into Acurx Pharmaceuticals' financials and future prospects, there are additional InvestingPro Tips available. These tips provide a comprehensive analysis of the company's performance and outlook, including its liquidity position and profitability metrics. Interested investors can find a total of 11 more InvestingPro Tips on https://www.investing.com/pro/ACXP, and can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.