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Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is a late-stage biopharmaceutical company specializing in developing innovative antibiotics designed to combat drug-resistant bacterial infections. The company's leading drug candidate, ibezapolstat, is an orally administered antibiotic developed to treat Clostridioides difficile infections (CDI), a serious and life-threatening condition. Acurx is advancing ibezapolstat to Phase 3 clinical trials to establish its efficacy and safety compared to standard treatments such as vancomycin.
Ibezapolstat works by targeting the Gram-Positive Selective Spectrum (GPSS®) and inhibiting the DNA polymerase IIIC enzyme critical for bacterial replication in Gram-positive bacteria. This mechanism not only effectively treats the infection but also preserves the healthy gut microbiome, thus reducing the likelihood of infection recurrence. Acurx’s studies have shown promising results, including a 96% clinical cure rate and excellent microbiome preservation, establishing non-inferiority to vancomycin.
The company has received multiple designations from the FDA, including Qualified Infectious Disease Product (QIDP) and Fast Track status, which highlight the urgent need for new antibiotics to treat CDI. These designations facilitate expedited development and review processes, enabling faster patient access to new treatments.
Recent progress includes the successful completion of a Phase 2b clinical trial, which demonstrated high clinical cure rates and no recurrence of infection in patients treated with ibezapolstat. The company has also reached critical milestones with regulatory agencies, including the FDA and EMA (European Medicines Agency), paving the way for international Phase 3 trials.
Acurx is committed to addressing the growing threat of antibiotic resistance. The company’s R&D pipeline includes additional antibiotics targeting other serious Gram-positive bacterial infections, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and drug-resistant Streptococcus pneumoniae.
Acurx Pharmaceuticals (NASDAQ: ACXP) will release its 2022 Q1 financial results on May 11, 2022, at 8:30 am ET. Following the results, a conference call will be held where CEO David P. Luci and CFO Robert G. Shawah will provide updates. The company is advancing its antibiotic ibezapolstat for treating C. difficile infections, with successful Phase 1 and 2a trials showing 100% clinical cure rates. Ibezapolstat has received FDA designations for streamlined development due to the urgent need for new treatments.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its financial and operational results for Q4 and full year 2021. The company is enrolling in a Phase 2b trial for its lead antibiotic, ibezapolstat, aimed at treating C. difficile infections. The trial compares ibezapolstat's efficacy against vancomycin. R&D expenses for the year decreased to $2.0 million, while general and administrative expenses rose significantly to $10.8 million, primarily due to stock-based compensation and increased professional fees. The net loss for 2021 was $12.7 million, with a loss per share of $(1.49).
Acurx Pharmaceuticals (NASDAQ: ACXP) announced that President & CEO David P. Luci will present at the 2022 Virtual Growth Conference hosted by Maxim Group LLC from March 28-30, 2022. Luci's fireside chat is scheduled for March 28 at 9:30 am ET. This event will feature various sectors, including Biotech and Healthcare. Acurx's lead antibiotic candidate, ibezapolstat, has shown promising results in its Phase 2a trial for C. difficile Infection, with a 100% efficacy in the primary and secondary endpoints. Acurx is currently enrolling for a Phase 2b trial comparing ibezapolstat to vancomycin.
Acurx Pharmaceuticals (NASDAQ: ACXP) will release its financial results for Q4 2021 and fiscal year 2021 on March 17, 2022, at 8:30 AM ET. The company will hold a conference call to discuss the results. Acurx is advancing its Phase 2 clinical trial of ibezapolstat, targeting C. difficile infections. The completed Phase 2a segment showed complete eradication of C. difficile by day three of treatment, with promising data on microbiome health. The ongoing Phase 2b trial will enroll 64 patients, comparing ibezapolstat to vancomycin.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced positive results from its Phase 2a clinical trial of ibezapolstat for treating Clostridioides difficile Infection (CDI), published in Clinical Infectious Diseases. All 10 patients in the trial achieved both primary and secondary efficacy endpoints, demonstrating a 100% Clinical Cure rate at the end of treatment. The trial reports favorable microbiome changes, including beneficial increases in Actinobacteria and Firmicutes. Acurx is now enrolling for a Phase 2b trial comparing ibezapolstat to vancomycin, with the goal of confirming non-inferiority.
Acurx Pharmaceuticals (NASDAQ: ACXP) has enrolled the first patient in its Phase 2b clinical trial of ibezapolstat, targeting Clostridioides difficile infection (CDI). This trial, consisting of 64 patients, aims to demonstrate non-inferiority compared to vancomycin, the current standard treatment. Previous Phase 2a results showed 100% eradication of CDI without recurrence, and favorable effects on the gut microbiome. Ibezapolstat has received FDA's QIDP and Fast Track designations, indicating a potential breakthrough in addressing CDI, which poses significant health risks.
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) reported its financial and operational results for Q3 2021, highlighting 12 clinical trial sites activated for a Phase 2b trial of ibezapolstat targeting C. difficile infection (CDI). The Phase 2a trial indicated a 100% clinical cure rate. Financially, R&D expenses rose to $1.1 million, while SG&A expenses surged to $3.5 million, resulting in a net loss of $4.6 million. As of September 30, 2021, the company has $14.5 million in cash.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced new findings from its Phase 2a trial of ibezapolstat for treating C. difficile infections (CDI), presented at the 9th International C. diff Conference on November 5, 2021. The trial highlighted complete eradication of C. difficile by day three and growth of healthy microbiota. Notably, ibezapolstat therapy increased secondary bile acids, suggesting reduced CDI recurrence risk compared to vancomycin. The upcoming Phase 2b trial will further evaluate pharmacokinetics and microbiome changes as Acurx looks to continue its positive trajectory in CDI treatment.
Acurx Pharmaceuticals (ACXP) announced the presentation of new microbiome data from its Phase 2a trial for C. difficile Infection (CDI) at the 9th Annual International C. diff Conference on November 5, 2021. The study demonstrated a 100% success rate in eliminating CDI infections with no recurrences. The trial, which was terminated early upon recommendation due to positive results, will proceed to Phase 2b, enrolling 64 additional patients. Acurx aims to further evaluate the effectiveness of ibezapolstat compared to vancomycin, focusing on treatment outcomes and microbiome changes.
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced it will release its 2021 third quarter financial results on November 15, 2021, at 8:30 am ET. CEO David P. Luci and CFO Robert G. Shawah will host a conference call to discuss the results and provide a business update. Acurx is developing Ibezapolstat, a novel antibiotic targeting resistant bacterial infections, which has received FDA designations including Fast Track and Qualified Infectious Disease Product for its potential treatment of C. difficile. The company is preparing for a Phase 2b clinical trial.
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