STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a biopharmaceutical company specializing in the development of new antibiotics, has reached a significant milestone in the advancement of its lead drug candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI). Following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company is preparing to enter international Phase 3 clinical trials.
The FDA has agreed on the key elements for the upcoming Phase 3 trials, which will include protocol design, patient population, primary and secondary endpoints, and the size of the registration safety database. These trials aim to determine whether ibezapolstat can achieve clinical cure and reduce recurrence of CDI compared to the standard-of-care vancomycin.
The Phase 3 trials will involve an estimated 450 subjects in a Modified Intent-To-Treat (mITT) population, randomized in a 1:1 ratio to either ibezapolstat or vancomycin, consistent with EMA requirements. If non-inferiority to vancomycin is demonstrated, further analysis will test for superiority.
Robert J. DeLuccia, Executive Chairman of Acurx, expressed satisfaction with the FDA's support and the company's readiness to initiate the first international Phase 3 trial. The company also has a complete development plan for filing a New Drug Application and subsequent Marketing Authorizations in other countries.
The Phase 2 clinical trial of ibezapolstat included a multicenter, open-label single-arm segment (Phase 2a), followed by a double-blind, randomized, active-controlled, non-inferiority segment (Phase 2b) at 28 U.S. clinical trial sites. The Phase 2 trials showed a 96% clinical cure rate for ibezapolstat, and the drug was well-tolerated with no serious adverse events.
Acurx Pharmaceuticals has also been granted SME designation by the European Medicines Agency (EMA), which provides fee incentives and support for EU Marketing Authorization. The company is preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan, and Canada.
Ibezapolstat is a novel, orally administered antibiotic and the first in a new class of DNA polymerase IIIC inhibitors. It has been designated as a Qualified Infectious Disease Product (QIDP) by the FDA and received Fast Track designation for the treatment of CDI.
This article is based on a press release statement, and the information provided is subject to verification through independent sources.
InvestingPro Insights
As Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) gears up for its international Phase 3 clinical trials, the financial landscape of the company presents a mixed bag of insights. According to InvestingPro data, ACXP boasts a market capitalization of $33.07 million, indicative of its small-cap status in the biopharmaceutical sector. The company's stock has shown a significant return over the last month, with a 27.83% price total return, highlighting investor optimism potentially spurred by the recent FDA developments and the progression of ibezapolstat. This is further reflected in the stock's one-week price total return of 7.73%.
However, the financial metrics also paint a picture of caution. The company holds a negative P/E ratio of -1.78, adjusted to -2.27 for the last twelve months as of Q4 2023, underlining that ACXP is not currently profitable. This aligns with one of the InvestingPro Tips that analysts do not anticipate the company will be profitable this year. Additionally, the stock is trading at a high Price / Book multiple of 7.09, which can be a concern for value-oriented investors.
For those closely monitoring Acurx Pharmaceuticals, the InvestingPro platform offers further insights. There are additional InvestingPro Tips available, such as the company's ability to manage its cash reserves effectively, holding more cash than debt, and its liquid assets exceeding short-term obligations. To explore these and other in-depth analytics, interested readers can visit InvestingPro's dedicated ACXP page. For a more comprehensive experience, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With a total of 10 InvestingPro Tips listed, investors can gain a nuanced understanding of Acurx's financial health and investment potential.
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