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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 announced the FDA's acceptance of its Interim Analysis Plan for an Independent Data Monitoring Committee (IDMC) to evaluate clinical outcomes in its Phase 2b clinical trial of ibezapolstat for treating Clostridioides difficile Infection (CDI) upon reaching 36 patient enrollments. This follows a successful Phase 2a trial, which demonstrated a 100% clinical cure rate. The Company will present findings at ECCMID 2023, including a poster on ibezapolstat's novel pharmacologic properties. The Phase 2b trial is a randomized, double-blind study comparing ibezapolstat to vancomycin, aiming to enroll 64 patients and assess anti-recurrence effects. Ibezapolstat has received QIDP and Fast Track designations from the FDA, highlighting its potential in an urgent therapeutic area. The Company also plans to share updates on its antibiotic pipeline at ECCMID.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its Q4 and full-year 2022 financial and operational results on March 16, 2023. The Company continues its Phase 2b clinical trial for ibezapolstat, with 25 patients enrolled and an interim data review expected mid-2023. Acurx's cash position decreased to $9.1 million from $13.0 million year-over-year. R&D expenses increased to $4.8 million for 2022, attributed to trial costs. The net loss narrowed to $12.1 million in 2022 from $12.7 million in 2021. The Company awaits a decision on an $11.3 million non-dilutive grant in April 2023.
Acurx Pharmaceuticals (NASDAQ: ACXP) will discuss its financial results for Q4 2022 and full-year 2022 on March 16, 2023, at 8:00 a.m. ET. The call, led by CEO David P. Luci and CFO Robert G. Shawah, follows the successful completion of the Phase 2a trial of ibezapolstat, a new antibiotic for treating Clostridioides difficile infection (CDI). The trial showed 100% infection cure at the end of treatment. The subsequent Phase 2b trial is currently enrolling patients to compare ibezapolstat with vancomycin. This segment will further analyze pharmacokinetics and microbiome changes, potentially reducing CDI recurrence risk.
Acurx Pharmaceuticals (NASDAQ: ACXP) has announced its participation in the Emerging Growth Conference on January 25, 2023. The event will feature a live, interactive session with President & CEO David P. Luci, allowing shareholders and the investment community to engage directly. The session is scheduled from 9:40 am to 10:10 am Eastern Time. Attendees can submit questions beforehand or ask live during the event. An archived version will be available post-event on EmergingGrowth.com. Acurx focuses on developing innovative antibiotics targeting challenging bacterial infections.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its financial results for Q3 2022, with a net loss of $3.5 million ($0.32 per diluted share), a decrease from a $4.6 million loss in Q3 2021. Cash reserves declined to $10.6 million from $13.0 million at the end of 2021. Increased R&D expenses reached $1.6 million, attributed to Phase 2b trial costs. General and administrative expenses fell to $2.0 million, down from $3.5 million a year prior. The company is expanding its C. difficile Infection clinical trial to 30 sites and presented favorable data on ibezapolstat at recent conferences.
Acurx Pharmaceuticals (NASDAQ: ACXP) will release its 2022 Q3 financial results on November 14, 2022, at 8:30 am ET. The company is focused on developing ibezapolstat, an innovative antibiotic targeting difficult-to-treat bacterial infections, particularly C. difficile. Acurx completed Phase 1 and Phase 2a clinical trials with promising results, including 100% clinical cure rates. The FDA has granted ibezapolstat 'QIDP' and 'Fast Track' designations. Acurx will host a conference call to discuss the financial results and provide a business update following the release.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported significant findings regarding ibezapolstat, an antibiotic targeting C. difficile infections. Data from a recent trial showed that ibezapolstat preserves beneficial gut bacteria while effectively treating C. difficile infection (CDI). The Phase 2b trial is currently enrolling up to 64 patients to compare ibezapolstat's efficacy against vancomycin. Notably, ibezapolstat has received FDA QIDP and Fast Track Designations, emphasizing its potential importance in combating CDI.
Acurx Pharmaceuticals (NASDAQ: ACXP) announced its participation in the IDWeek 2022 Conference, presenting new data on ibezapolstat, an antibiotic targeting C. difficile infections (CDI). Key presentations include an oral update and a poster on ibezapolstat’s selective action against gut microbiota, emphasizing its clinical trial success. The Phase 2a trial showed 100% clinical cure rates in CDI patients. The company is currently enrolling in a Phase 2b trial comparing ibezapolstat to vancomycin.
Acurx Pharmaceuticals (NASDAQ: ACXP) reported financial and operational results for Q2 2022, highlighting ongoing enrollment in its Phase 2b clinical trial for C. difficile Infection (CDI) and the addition of clinical sites due to slower enrollment. The company raised $4.225 million from a registered direct offering and has $9.1 million in cash as of June 30, 2022. R&D expenses increased to $0.9 million, while G&A expenses decreased to $1.7 million. The net loss was $2.6 million, a reduction from $4.0 million in Q2 2021. A conference call is scheduled for August 16, 2022.
Acurx Pharmaceuticals (NASDAQ: ACXP) will release its Q2 2022 financial results on August 16, 2022, at 8:30 am ET. CEO David P. Luci and CFO Robert G. Shawah will host a call to discuss the results and provide a business update.
The company is developing Ibezapolstat, a new antibiotic targeting C. difficile infections, with promising Phase 2a trial results showing 100% clinical cure. Ibezapolstat has received FDA designations as a QIDP and Fast Track product.
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