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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) announced promising results for ibezapolstat in a Phase 2a clinical trial targeting Clostridioides difficile infections during the IDWeek 2021 conference. The trial highlighted a 100% eradication rate of C. difficile by day three and showed favorable microbiome effects compared to vancomycin, including growth of beneficial bacteria. The company is advancing to a Phase 2b trial this quarter to compare ibezapolstat with vancomycin, focusing on pharmacokinetics and microbiome changes.
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) announced its participation in the A.G.P. Biotech and Specialty Pharma Conference on October 13, 2021. The event will feature one-on-one virtual investor meetings aimed at discussing the company's innovative antibiotic developments targeting difficult bacterial infections.
The company's pipeline includes candidates for treating Clostridioides difficile, MRSA, VRE, and drug-resistant Streptococcus pneumoniae. For more information, visit www.acurxpharma.com.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced a scientific poster presentation at IDWeek 2021 focusing on its Phase 2a clinical trial of Ibezapolstat for Clostridioides difficile infection (CDI). The trial has shown 100% success in eliminating the infection without recurrence among 10 treated patients, leading to the early termination of the Phase 2a segment. A Phase 2b trial will further investigate Ibezapolstat against vancomycin in 64 patients. CDI is a significant healthcare issue, with annual U.S. infections approaching 600,000 and a mortality rate of about 9.3%.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced its upcoming inclusion in the Russell Microcap Index effective September 20, 2021. This inclusion is based on market-capitalization rankings and style attributes, lasting for one year. The company aims to develop a new class of antibiotics, with its lead candidate, ibezapolstat, targeting C. difficile infections. CEO David P. Luci highlighted that this recognition enhances the company's visibility among investors and reflects progress in their drug development objectives.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced that David P. Luci, President & CEO, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 A.M. ET. This conference will take place from September 13-15, 2021. Investors can access the live presentation via a webcast link provided in the press release. Acurx focuses on developing novel antibiotics for challenging infections, targeting Gram-positive bacteria such as Clostridioides difficile and MRSA.
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) reported its second quarter 2021 results, highlighting significant developments in its antibiotic research. The company received a $500,000 grant from Health Holland for collaboration on DNA pol IIIC inhibitors and filed a provisional patent for ibezapolstat aimed at treating C. difficile Infection (CDI). Financially, Acurx showed a net loss of $4.0 million for the quarter, up from $0.9 million the previous year, with increased administrative expenses of $3.9 million. As of June 30, 2021, the cash balance stood at $17.1 million.
Acurx Pharmaceuticals, a clinical stage biopharmaceutical company focused on innovative antibiotics, will have its President & CEO, David P. Luci, present at the Emerging Growth Conference on August 18, 2021, at 11:15 a.m. Eastern Time. This interactive online event aims to engage current stockholders and the investment community, allowing for potential Q&A. The conference will be webcast live and archived for 30 days on the company's website. Acurx is developing antibiotics targeting hard-to-treat infections, including MRSA and VRE.
Acurx Pharmaceuticals (Nasdaq: ACXP) announced a $500,000 grant from Health Holland to support a collaborative research project with Leiden University Medical Center. This project aims to explore the structure of DNA polymerase C from multi-drug resistant bacteria, enhancing the development of new antibiotics. Acurx will begin a Phase 2b clinical trial for Clostridioides difficile Infection (CDI) in late 2021, following promising results from an earlier trial where 100% of patients achieved primary efficacy endpoints. The research may lead to innovative treatments for serious Gram-positive pathogens.
Acurx Pharmaceuticals (NASDAQ: ACXP) will release its Q2 2021 financial results on August 17, 2021, at 8:30 a.m. ET. A conference call will be hosted by President David P. Luci and CFO Robert G. Shawah to discuss these results and provide a business update. The company is developing ibezapolstat, a novel oral antibiotic for C. difficile infection, which has received FDA designations as a Qualified Infectious Disease Product and Fast Track designation. Acurx plans to enroll in a Phase 2b efficacy study by the end of 2021.
Acurx Pharmaceuticals (NASDAQ: ACXP) filed a provisional patent for ibezapolstat, targeting Clostridioides difficile Infection (CDI) and aiming to improve gut microbiome health. Following a successful Phase 2a trial with a 100% clinical cure rate, Acurx will initiate a Phase 2b trial later this year. The company's approach focuses on dual-action therapy, potentially enhancing patient outcomes and reducing recurrence rates. The announcement reflects Acurx's commitment to protecting its antimicrobial technologies.
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