STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) recently presented scientific findings at the IDWeek 2024 Conference, showcasing favorable outcomes from a Phase 2 trial of its drug candidate ibezapolstat, intended for the treatment of C. difficile Infection (CDI). The trial compared ibezapolstat to vancomycin, a standard CDI treatment, and indicated a comparable safety profile and clinical cure rates, with additional benefits observed in the gut microbiome of patients treated with ibezapolstat.
The Phase 2b study demonstrated that ibezapolstat-treated patients exhibited an increased proportion of beneficial gut bacteria and a higher ratio of secondary to primary bile acids compared to those treated with vancomycin. These results suggest a potential anti-recurrence effect of ibezapolstat in CDI patients. Dr. Kevin Garey, one of the principal investigators, highlighted that the preservation of beneficial bacteria and the favorable bile acid profile could provide resistance against C. difficile recolonization.
Acurx is moving forward with preparations for international Phase 3 clinical trials and plans to seek regulatory guidance for initiating trials in the European Union, followed by the United Kingdom, Japan, and Canada. The company has already reached an agreement with the FDA on key elements of the Phase 3 trials, including study design and patient population.
The Phase 2 clinical trial, conducted across 28 U.S. sites, reported a 96% clinical cure rate in patients treated with ibezapolstat. No recurrences were observed in patients who were followed for three months post-treatment. These promising results support the company's anticipation of confirming ibezapolstat's efficacy in the upcoming Phase 3 studies.
Ibezapolstat has received QIDP and Fast-Track Designation from the FDA, recognizing the urgency in developing new treatments for CDI, which is considered an urgent threat by the CDC. The drug candidate functions by inhibiting DNA polymerase IIIC, essential for bacterial DNA replication, and is the first in a new class of small molecule antibiotics being developed by Acurx.
The information presented is based on a press release statement from Acurx Pharmaceuticals, Inc.
In other recent news, Acurx Pharmaceuticals has reported significant developments with its antibiotic candidate, ibezapolstat. The company has announced positive research findings, including the drug's beneficial impact on the gut microbiome and its promising activity against Anthrax strains. This has led to the planning of an Anthrax bioterrorism development program and the progression to international Phase 3 clinical trials for ibezapolstat.
The company has also revealed financial results for the second quarter of 2024, reporting a net loss of $4.1 million and a cash reserve of $6.4 million. Despite the net loss, Acurx is actively seeking partnerships and non-dilutive funding options to finance the estimated $50 million cost of the Phase 3 trials. The company expects its funds to last until mid-2025 or mid-2026.
Acurx Pharmaceuticals is also preparing for regulatory submissions in the European Union, the United Kingdom, Japan, and Canada for ibezapolstat. The antibiotic has received FDA QIDP and Fast-Track Designation, highlighting its potential against C. difficile Infection (CDI), considered an urgent threat by the CDC. These are the recent developments in Acurx Pharmaceuticals' growth trajectory.
InvestingPro Insights
As Acurx Pharmaceuticals (NASDAQ: ACXP) advances its promising ibezapolstat drug candidate, investors should consider some key financial metrics and insights from InvestingPro.
The company's market capitalization stands at $32.65 million, reflecting its current valuation in the biotech sector. An InvestingPro Tip indicates that ACXP holds more cash than debt on its balance sheet, which could provide financial flexibility as it moves forward with Phase 3 clinical trials. This strong liquidity position is further supported by another InvestingPro Tip noting that the company's liquid assets exceed short-term obligations.
However, it's important to note that ACXP is not currently profitable, with an adjusted operating income of -$16.73 million over the last twelve months as of Q2 2023. This aligns with the early-stage nature of the company's drug development process and the significant investments required for clinical trials.
The stock's performance has been challenging, with a one-year price total return of -61.2% as of the latest data. This decline may reflect the inherent risks and uncertainties in biotech drug development, as well as broader market conditions.
Investors considering ACXP should be aware that analysts do not anticipate the company to be profitable this year, according to another InvestingPro Tip. This is not unusual for biotech companies in the clinical trial phase, but it underscores the speculative nature of the investment.
For those interested in a deeper analysis, InvestingPro offers additional tips and insights, with 8 more tips available for ACXP on the platform. These could provide valuable context for understanding the company's financial health and market position as it progresses through this critical phase of drug development.
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