ACXP - Acurx Is Vying for Standard of Care in Treating Primary and Recurrent C. diff
(NewsDirect)
By Faith Ashmore, Benzinga
C. diff is alife-threatening bacterial infection that causes diarrhea and colitis,which is the inflammation of the colon. Approximately 600,000 are diagnosed with C. diff each year in the United States and it causes approximately 55deaths a day. In the elderly population, 1 in 11 individuals over the age of 65 die within the month afterbeing infected. The infection has a high recurrent rate, about 1 in 6patients who get C. diff will get it again within 2-8 weeks.
The current treatmentfor C. diff is vancomycin, an antibiotic that is typicallyprescribed for serious pathogenic infections. While the drug is safeand has proven successful, the antibiotic has been on the market for65 years and its effectiveness has been steadily declining as more andmore bacteria have become resistant to it, consistent with the path ofvirtually all other antibiotics over time.
Understanding the needfor a new antibiotic to treat C. diff, Acurx Pharmaceuticals ( Nasdaq: ACXP ) isdeveloping ibezapolstat, a novel first-in-class antibiotic currentlyin mid-stage clinical testing. It has been given Fast Trackdesignation by the FDA and has been designated by the FDA as aQualified Infectious Disease Product (QIDP), which grants priorityreview by the FDA and provides an additional five years of marketexclusivity upon approval. The CDC acknowledges an ”urgent need”for new antibiotics to treat C. diff.
During the Phase 2a clinical trial, 100% of the first 10patients were clinically cured of C. diff and did not have arecurrent infection within a 28-day period after the end of treatmentwith no safety concerns. Because of these strong results, theScientific Advisory Board recommended that the trial be stopped earlyfor success.
The currentstandard of care, vancomycin, has an average clinical cure rate of 80%with a 30% chance of recurrent infection. In comparison, ibezapolstatwould be a far more suitable drug with a higher success rate ifcurrent data holds in late-stage development. Acurx is expectingsimilarly strong results for their Phase 2b clinical trial. Thecompany is expected to release topline results by mid-2023 if the FDAagrees with the company’s plan for an interim analysis.
If the trials continueto be a success and ibezapolstat demonstrates statisticalnoninferiority compared to vancomycin in curing primary C. diff, itcould win FDA approval and be used as first line therapy. But ofequal, or even greater, importance are the results being shown inpreventing recurrence -- the major cause of C. diff morbidity andmortality, and the principal contributor to C. diff’s $4.5 billionannual cost to the US healthcare system.
Being able to reduce or eliminate recurrence would be agame-changing development in treating an infection that affects somany individuals, especially amid rising bacterial resistance tovancomycin.
Ibezapolstat’spotential game-changing status would be further assured if it scoreswell in two exploratory endpoints in the current Phase 2b trial –the number of disease-free patients at days 60 and 90 (two time pointsnot included on any product labeled for C. diff.) and if it continuesto demonstrate restoration of the healthy microbiome of C. diffpatients during the treatment process.
Click here for moreinformation about Acurx.
About Acurx Pharmaceuticals,Inc .
Acurx Pharmaceuticals is a clinical stagebiopharmaceutical company focused on developing an entirely new classof antibiotics for difficult to treat infections. The Company'sapproach is to develop antibiotic candidates that target the DNApolymerase IIIC enzyme and its R&D pipeline includes antibioticproduct candidates that target Gram-positive bacteria, includingClostridioides difficile, methicillin-resistant Staphylococcus aureus(MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistantStreptococcus pneumoniae (DRSP). To learn more about AcurxPharmaceuticals and its product pipeline, please visit www.acurxpharma.com
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