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• Acurx is proud to sponsor this inaugural Scientific Symposium of the Peggy Lillis Foundation (PLF) for C. Diff Education & Advocacy
• An update of ibezapolstat Ph2b clinical and microbiome results was presented
• Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)
• Acurx continues preparation to submit requests for regulatory guidance to initiate clinical trials in the European Union to be followed by Japan, Canada and the United Kingdom
• Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA

STATEN ISLAND, N.Y., Nov. 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced its support and participation in the Inaugural Peggy Lillis Foundation (virtual) Scientific Symposium, held on Friday, November 15, 2024.

Acurx's Executive Chairman, Bob DeLuccia, delivered opening remarks for the symposium聽which assembled experts and thought leaders from around the world to present state-of-the art updates regarding C difficile Infection and therapeutic options. Topics covered included epidemiology, bacterial physiology, risk factors for infections, and new and emerging treatment modalities. The Symposium also included testimonials from patients who survived聽CDI.

Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, Principal Investigator for microbiology and microbiome aspects of the聽ibezapolstat聽clinical聽trial聽program, and聽Acurx聽Scientific聽Advisory聽Board聽member, delivered a presentation entitled:听"Ibezapolstat Preserves Key Clostridium Leptum Species: Microbiome Results from the Phase 2, Randomized, Double-Blind Study."

According to Dr. Garey: "In contrast to聽patients dosed with vancomycin, ibezapolstat has consistently shown in the phase 1 and 2 studies that it promotes the growth of beneficial Actinobacteria important for short chain fatty acid production and Clostridiales important for bile acid homeostasis. At the same time, it does not promote the overgrowth of potentially harmful Proteobacteria." He further added: "Ibezapolstat showed a favorable secondary to primary ratio of bile acids which is linked to a lower recurrence rate of CDI. I'm excited to see this new antibiotic advance to phase 3 clinical trials for the treatment of acute C. difficile Infection, particularly considering the favorable effects on bile acid homeostasis, which could lead to a reduction in CDI recurrence, a current unmet medical need with currently marketed antibiotics."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "As a leader in the field with the first new class of antibiotics in decades now preparing to enter Ph3 international trials for the treatment of acute CDI and reduction of recurrence, we are very excited to have sponsored this event to support the PLF and to present an update on ibezapolsat's Ph2b data, particularly during November being CDC-designated as Cdiff Awareness month."聽Dr. Garey's presentation is available on the Acurx Pharmaceuticals website at .

Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of聽颁.听诲颈蹿蹿颈肠颈濒别听Infection.聽Agreement聽with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada.

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an聽EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population consistent with EMA requirements. This will聽result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

础产辞耻迟听the Peggy Lillis Foundation 聽
The Peggy Lillis Foundation (PFL) is building a nationwide C. DIFF (Clostridioides difficile) awareness movement by educating the public, empowering advocates and shaping public policy. Currently, PLF is going beyond its early beginnings as a patient advocacy group to raise awareness of Cdiff, but now is building a broader foundation by uniting researchers, clinicians, and the medical community, along with all advocates to share groundbreaking research findings, foster collaboration and ultimately enhance cdiff patient outcomes.
For more information about聽PLF please visit:

础产辞耻迟听the聽Ibezapolstat Phase 2聽Clinical聽Trial
The聽completed multicenter,聽open-label聽single-arm聽segment聽(Phase聽2a)聽study聽was聽followed by聽a聽double-blind,聽randomized,聽active-controlled,聽non-inferiority,聽segment聽(Phase 2b)聽at 28 US clinical trial sites which together comprise the Phase 2 clinical trial.
(). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment, 10 patients with diarrhea caused by C. difficile聽were treated with聽ibezapolstat聽450聽mg聽orally, twice聽daily聽for聽10聽days.聽All聽patients were聽followed聽for recurrence聽for聽28卤聽2聽days.聽Per聽protocol,聽after聽10聽patients of聽the聽projected聽20聽Phase聽2a patients completed treatment (100% cured infection at End of Treatment).

In聽the聽Phase聽2b聽trial聽segment, which聽was聽discontinued聽due聽to聽success, 32聽patients聽with聽CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 卤 2 days聽following聽the聽end聽of聽treatment聽for聽recurrence聽of聽CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.聽The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat.聽Ibezapolstat聽was聽well-tolerated,聽with聽three聽patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events,聽or聽other聽safety聽findings聽of聽concern.聽In聽the聽Phase聽2b聽vancomycin聽control聽arm,聽14聽out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin庐 Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially聽overgrowth聽of聽healthy聽gut聽microbiota聽Actinobacteria聽and聽Firmicute聽phylum聽species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile.聽A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence聽of聽infection.聽In聽the聽vancomycin聽control聽arm聽of聽the聽trial,聽7聽of聽7聽patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 卤 2 days post EOT (ECC56) and 84 卤 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection.聽Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

础产辞耻迟听滨产别锄补辫辞濒蝉迟补迟
Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS庐) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development聽by聽Acurx to聽treat聽bacterial聽infections.聽Ibezapolstat's聽unique spectrum聽of聽activity, which聽includes聽颁.听诲颈蹿蹿颈肠颈濒别听but聽spares聽other Firmicutes聽and聽the聽important聽Actinobacteria聽phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019,聽FDA聽granted "Fast聽Track"聽designation聽to聽ibezapolstat聽for聽the聽treatment of聽patients聽with CDI. The CDC has designated C. difficile聽as an urgent threat highlighting the need for new antibiotics to treat CDI.

础产辞耻迟听颁濒辞蝉迟谤颈诲颈辞颈诲别蝉听诲颈蹿蹿颈肠颈濒别听滨苍蹿别肠迟颈辞苍听(颁顿滨)
According聽to聽the聽2017聽Update聽(published聽February聽2018)聽of聽the聽Clinical Practice聽Guidelines for聽颁.听诲颈蹿蹿颈肠颈濒别听Infection聽by聽the聽Infectious聽Diseases聽Society聽of聽America聽(IDSA) and聽Society聽or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community.聽C. difficile聽is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile聽approaches 500,000聽infections聽annually聽in聽the聽U.S.聽and聽is聽associated聽with聽approximately聽20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

础产辞耻迟听the聽Microbiome聽in聽颁.听诲颈蹿蹿颈肠颈濒别 滨苍蹿别肠迟颈辞苍听(颁顿滨) and Bile Acid Metabolism
C. difficile聽can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the聽C. difficile聽can thrive and cause an infection. After colonization聽with 颁.听诲颈蹿蹿颈肠颈濒别,聽the聽organism聽produces and聽releases聽the聽main聽virulence聽factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8,聽200;聽doi:10.3390/microorganisms8020200.)聽TcdA聽and聽TcdB聽are聽exotoxins聽that聽bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.聽Bile聽acids perform聽many聽functional聽roles聽in聽the聽GI聽tract, with聽one聽of聽the聽most聽important聽being maintenance of a healthy microbiome by inhibiting C. difficile聽growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of聽C. difficile聽spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile聽sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported聽(CID,聽2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

础产辞耻迟听Acurx Pharmaceuticals,聽Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum聽(GPSS庐)聽that聽blocks聽the聽active聽site聽of聽the聽Gram-positive聽specific bacterial聽enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial聽cell聽death. Its聽R&D聽pipeline includes聽antibiotic聽product candidates聽that聽target Gram- positive聽bacteria,聽including 颁濒辞蝉迟谤颈诲颈辞颈诲别蝉听诲颈蹿蹿颈肠颈濒别,听尘别迟丑颈肠颈濒濒颈苍-谤别蝉颈蝉迟补苍迟听厂迟补辫丑测濒辞肠辞肠肠耻蝉听补耻谤别耻蝉 (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit .

Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects,"聽and聽similar expressions,聽constitute聽forward-looking聽statements聽within聽the聽meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2023, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and聽Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

Investor Contact:
Acurx Pharmaceuticals, Inc.
David聽P.聽Luci, President & CEO
Tel: 917-533-1469
贰尘补颈濒:听davidluci@acurxpharma.com

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SOURCE Acurx Pharmaceuticals, Inc.