New York, New York--(Newsfile Corp. - February 7, 2023) - Soulstring Media Group, Llc., a market research, aggregator, and digital media production and management company specializing in creating and syndicating content from publicly traded and private companies, announced today that it had published an in-depth interview with Acurx Pharmaceuticals (NASDAQ: ACXP) President and CEO, Mr. David Luci. The interview discusses ACXP's ongoing Phase 2b trial utilizing ibezapolstat to treat C. difficile and why he believes his company is positioned to deliver a front-line treatment for the debilitating disease. To view the entire interview, along with disclosures and disclaimers, please follow this link:
Acurx Pharmaceuticals intends to develop a potential new class of antibiotics to treat serious or life-threatening infections, an opportunity resulting from a public health crisis that has been highlighted repeatedly by regulatory agencies worldwide.
Regulatory bodies such as the CDC and WHO suggest the world may be entering a "post-antibiotics" era where simple bacterial infections can become life-threatening. Responding to what it believes is a global need, Acurx is advancing two studies that, if FDA approved, would serve different ends of treating patients with C. difficile, including multiple-recurrent patients with C .difficile and as a front-line therapy in patients with mild or moderate C difficile.
Commenting on his Ibezapolstat and his Phase 2b trial, Mr. Luci said in the interview, "Our ibezapolstat is new to treating patients with C difficile infection. We think it can emerge as a candidate for front-line therapy for several reasons, including its currently holding a 100% cure rate based on existing data in Ph2a and its cure rate is durable with no reinfections. There is science behind these data. For the first time we have seen, we are actually testing some patients in the Ph2b trial for up to 90 days after end of treatment to demonstrate the cure rate is in fact quite durable.
We are seeing a restored microbiome 3-5 days after the start of treatment with our drug making durable cures more likely. We are also seeing a healthy concentration of secondary bile acids in cured patients compared to the oral vancomycin standard of care from historical data. This is a scientific marker for low risk of reinfection and related high likelihood of a durable cure. These data are available on our website as presented at several scientific conferences in 2022. Further, we're seeing over 100 times the concentration of our drug needed to kill the C difficile bacteria reaching the site of the infection, making it unlikely for a treatment failure."
Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.
The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat. The Phase 2a trial demonstrated 100% clinical cure and 100% sustained clinical cure in patients with C. difficile Infection (CDI), along with beneficial microbiome changes during treatment including overgrowth of Actinobacteria and Firmicutes phylum species while on therapy and new findings which demonstrate potentially beneficial effects on bile acid metabolism. Acurx is currently enrolling patients in its Phase 2b 64-patient, randomized (1-to-1), non-inferiority, double-blind trial of oral ibezapolstat compared to oral vancomycin, a standard of care to treat CDI.
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, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).
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