Acurx Pharmaceuticals, LLC (“Acurx” or the “Company”), a privately held, clinical stage biopharmaceutical company developing new antibiotics for difficult-to-treat bacterial infections, announced on July 27th, 2020 that a Phase 2 clinical trial of the Company’s lead antibiotic product candidate is in progress. In this trial, orally-administered ibezapolstat given 450 mg twice daily for 10 days will be evaluated for the treatment of patients with CDI. FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track status to ibezapolstat for patients with CDI.
Up to 6 study centers in the U.S. will participate in the first segment (Segment 2A) of the trial. Additional information about the trial, including eligibility criteria, can be found at www.clinicaltrials.gov (Study identifier: NCT04247542). This Phase 2, multicenter, open-label single-arm segment (Segment 2A) will be followed by a double-blind, randomized, active-controlled segment (Segment 2B), and is designed to evaluate both clinical cure and sustained clinical cure, safety, and pharmacokinetics. All patients in both segments will have stool samples tested for ibezapolstat concentrations and microbiome effects. Pharmacokinetic testing for systemic exposure will be performed on blood samples in Segment 2A. All of the first 6 patients enrolled in the trial have met the study’s primary endpoint, Clinical Cure at end of treatment. All patients who have reached the 30-day follow-up milestone, no recurrence of CDI, have achieved Sustained Clinical Cure, the study’s secondary endpoint. Ibezapolstat has been well-tolerated in all patients to date. After the first 10 patients have completed treatment, the study’s Trial Oversight Committee will assess the ibezapolstat safety profile in relationship to treatment outcomes and will advise the company on any recommended trial modifications which could include early termination of Phase 2A and acceleration of the double-blind Segment 2B.
Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx, stated “With today’s heightened awareness of antimicrobial resistance, even more so in the current Covid-19 environment, and the need for new classes of antibiotics to fight this global crisis, we are very excited to advance ibezapolstat to this stage of clinical development.” He further stated, “This is a significant value-creating development milestone for our Company. We believe this now clinically validated target of inhibition of bacterial DNA pol IIIC will pave the way forward for our pipeline of new oral/I.V. antibiotics in pre-clinical development to treat other Gram-positive life-threatening infections in skin/skin structure, community acquired pneumonia, bone & joint and bacteremia. This will include pathogens resistant to currently available antibiotics, and classified as priority pathogens by the WHO, CDC and FDA, all of whom emphasize the need for new classes of antibiotics to prepare for the next global infectious disease threat.”
Additionally, the U.S. Center for Diseases Control recently issued its 2019 update on antimicrobial resistance https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf and reaffirmed that CDI remains an URGENT threat causing at least 12,800 deaths in 2017, highlighting the need for new antibiotics, particularly those with a novel mechanism of action. It further reported that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year and more than 35,000 people die as a result, nearly twice as many annual deaths than previously reported by CDC in 2013. These deaths are attributed to antimicrobial-resistant pathogens including Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains), which are the targets of Company’s second antibiotic candidate currently in preclinical development.
About the Phase 2 Clinical Trial. In Segment 2A of this trial, up to 20 subjects with diarrhea caused by C. difficile will be treated with ibezapolstat 450 mg orally for 10 days and evaluated for clinical cure. All cured subjects will be followed for sustained clinical cure at 28 ± 2 days. In Segment 2B, approximately 64 additional subjects with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and followed for 28 ± 2 days for recurrence. The two treatments will be identical in appearance, dosing times, and number of capsules administered to maintain the blind. Subjects in both segments will be evaluated for clinical and sustained clinical cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles.
Additional information about the trial, including eligibility criteria can be found at: www.clinicaltrials.gov (Study identifier: NCT04247542).
About ibezapolstat, FDA QIDP and Fast Track Designation. In June 2018, FDA granted Qualified Infectious Disease Product (QIDP) designation to ibezapolstat as an oral treatment for patients with CDI. In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI.
FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Acurx acquired ibezapolstat from GLSynthesis, Inc. in February 2018.
FDA’s QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by FDA. Further, if ultimately approved by the FDA, ibezapolstat is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity. Ibezapolstat is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with CDI. Acurx is planning to advance ibezapolstat into a Phase 2 clinical trial in first quarter 2020. The CDC (Centers for Disease Control & Prevention) has designated Clostridium difficile bacteria as an urgent threat highlighting the need for new antibiotics to treat CDI.