Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) stock may present an investment opportunity that is too good to ignore. That assessment is more than warranted; it's justified, based on results from its Phase 2b clinical trial of its lead antibiotic candidate, ibezapolstat, for treating patients with Clostridioides difficile Infection (C. difficile, CDI). The data is more than compelling; it puts the target ACXP aims for, front-line treatment designation, in its crosshairs. And plenty supports hitting the bullseye.
Specifically, data showed that ACXP's ibezapolstat outperformed the standard of care, vancomycin, with a 94% eradication rate of fecal C. difficile at Day 3, compared to 71% for vancomycin. That's not all. Ibezapolstat preserved key gut bacterial species, believed to prevent CDI recurrence, a result vancomycin has been unable to duplicate in the Phase 2b trial as well as its known data since approval for CDI in 1986. And there could be more excellent news to come.
Further analyses of Phase 2b trial data were released on January 18, 2024, and the scientific poster is on the company website at www.acurxpharma.com. These data were presented at the Gulf Coast Consortia AMR Conference. In addition to that, the Company will announce extended clinical cure data 94 days out, which is a first in clinical history for patients treated for CDI with an antibiotic, as well as an upcoming announcement of the company’s FDA submission to finalize the Phase 3 clinical trial with the FDA.
Phase 2 Trial Data Supports Front-Line Designation
The Phase 2 clinical trial included an open-label segment (Phase 2a) and a double-blind, randomized, active-controlled segment (Phase 2b), with ibezapolstat demonstrating a 96% clinical cure rate across both phases, with well-tolerated adverse events. Notably, both trials were discontinued early due to success, and more importantly, the data earned increased ACXP's confidence about demonstrating non-inferiority to vancomycin in Phase 3 trials. There's more to appreciate.
The trial results support ongoing scientific investigations into ibezapolstat's anti-CDI recurrence effects, emphasizing its unique mechanism of action that doesn't target native gut bacteria. That differentiation is an advantage that appears to be unmatched by any known C. difficile treatment, supporting ACXP's intent to advance ibezapolstat into Phase 3 trials, with expectations for the drug to prove its potential front-line worth as a comprehensive solution with clinical comparability, microbiome health, safety, and cost for CDI patients.
Designated as a Fast Track drug by the FDA, that could happen sooner rather than later. If so, that will be more than great news for patients; it can be for ACXP investors, too, noting the drug will target the $1 billion-plus US CDI market as well as potential revenues from European, UK, Canadian and Japanese markets, where the company is also seeking a pathway toward fast approvals.
Keep in mind that ACXP is presenting compelling data at the right time. The Centers for Disease Control and Prevention (CDC) has labeled C. difficile as an urgent threat, underscoring the critical need for new antibiotics to address the challenges associated with the infection, which is a significant medical issue in various healthcare settings, including hospitals, long-term care facilities, and the broader community. Estimates included in a 2020 New England Journal of Medicine report indicate that C. difficile causes approximately 500,000 infections annually in the United States, leading to around 20,000 deaths yearly. Worse, the recurrence rate for CDI, with the currently employed antibiotics, is estimated to be between 20% and 40% among approximately 150,000 treated patients.
Outperforming Standard Of Care, Vancomycin
Acurx Pharmaceuticals aims to cure this pressing disease and is well on its way to doing so, noting that ibezapolstat is doing more than showing promising results in clinical trials; it's outperforming the current standard of care in critical areas. That led to both arms of the Phase 2 clinical trial of ibezapolstat being discontinued due to successful outcomes, a decision made in consultation with independent medical, scientific advisors, and statisticians based on blinded data analysis and considering factors like trial site maintenance costs and COVID-19-related enrollment challenges.
The Independent Data Monitoring Committee (IDMC) review, originally planned for the Phase 2b trial, was not required due to the trial's actual performance, but there was unanimous consensus at the IDMC that early discontinuation of the Phase 2b trial was most appropriate. Thus, the early termination can expedite ibezapolstat's progression to Phase 3 clinical trials, which, as noted, could be fueled by being a Qualified Infectious Disease Product (QIDP), Fast Tracked by the FDA, and presenting clinical cure rates for the primary efficacy endpoint of ibezapolstat's clinical activity in treating CDI.
The latter is a powerful contribution. In the Phase 2 clinical trial, evaluations included pharmacokinetics (PK), microbiome changes, and testing for anti-recurrence microbiome properties. Phase 2a data revealed complete colonic C. difficile eradication by day three of ibezapolstat treatment, along with observed overgrowth of healthy gut microbiota, Actinobacteria, and Firmicute phyla species during and after therapy. Emerging data suggested increased secondary bile acids during and after ibezapolstat therapy, correlating with colonization resistance against C. difficile. The decrease in primary bile acids and a favorable increase in the secondary-to-primary bile acids ratio indicated potential for reducing CDI recurrence compared to vancomycin. That's a benefit that's taken nearly five decades to show.
And more may come. Remember, ibezapolstat is the first of a new class of DNA polymerase IIIC inhibitors under development by ACXP to treat bacterial infections. In other words, as a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial, pipeline indications could swell as more data posts.
A Compelling Value Proposition
If so, the value proposition presented at current prices could be an investment gift that keeps on giving.
And keep in mind that while ACXP has an ATM to raise capital to fund its planned Phase 3 trial, it may not need to. Partnership interest, and the competitive interest from it, could be intense, noting that pharma companies like Pfizer (NYSE: PFE), Sanofi (NYSE: SNY), and others may be interested in recouping clinical trial losses from their failed attempts at bringing an effective C. difficile drug to market.
That's speculative. However, knowing that big pharma companies now prefer to acquire drugs once they are de-risked rather than develop them, ACXP's chance to partner is certainly a value driver to keep in mind. If they do, ACXP's roughly $50 million market cap could surge, a presumption based on past peer valuations that skyrocketed after entering Phase 3 trials. Considering that ACXP is positioned better than ever independently, could score near-term partnership interest, and, as importantly, may have the drug to earn front-line designation to treat a multi-billion dollar C. difficile patient market, it's timely to suggest that history repeating to the benefit of ACXP may be more than likely in 2024- it's probable.
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