Acurx Pharmaceuticals, Inc. · NASDAQ:ACXP
Acurx Pharmaceuticals — ESCMID 2024, Barcelona
13 slides from Acurx Pharmaceuticals's conference presentation, Apr 20, 2024
Slide 1: Efficacy and safety of ibezapolstat compared with vancomycin for C. difficile infection
Efficacy and safety of ibezapolstat compared with vancomycin for the treatment of Clostridioides difficile infection: a phase 2, randomized, double-blind study Kevin W. Garey, M Jahangir Alam, Khurshida Begum, Jacob McPherson, Taryn A. Eubank, Michael H. Silverman for the Ibezapolstat Phase 2 Invest
Slide 2: Ibezapolstat (IBZ; ACX362E)
Ibezapolstat (IBZ; ACX362E) ACX-362 dGTP • Ibezapolstat: small-molecule inhibitor of DNA pol IIIC enzyme based upon competitive inhibition of dGTP (guanosine analog) • DNA pol IIIC: essential for replication of low G+C content Gram-positive bacteria (Firmicutes) • Novel mechanism of action GPSS™ (Gr
Slide 3: IBZ Clinical Trial Update
IBZ Clinical Trial Update Garey et al. J Antimicrob Chemother 2020; Garey et al. Clin Infect Dis 2022
Slide 4: IBZ PH2b Objectives
IBZ PH2b Objectives • Evaluate IBZ vs. Vanco in patients with CDI for • Efficacy* • Initial cure, sustained clinical cure, microbiologic eradication, time to resolution of diarrhea • Safety* • Pharmacokinetics and fecal concentrations • Fecal microbiome effects *Focus of this presentation
Slide 5: Phase 2b Study design
Phase 2b Study design Patients followed daily for 12 days + follow-up Patients with mild/moderate CDI diagnosed using an EIA free toxin kit Outcome Measures Ibezapolstat 450 mg BID X 10 days Initial clinical cure (day 12 evaluation) Sustained clinical cure (day 38) Extended clinical cure (3 months)
Slide 6: Consort Diagram
Consort Diagram The trial was originally designed to be a non-inferiority (NI) trial and Patients was discontinued early due to enrolled (n=32) success. Decision made in consultation with medical and scientific advisors and statisticians based on observed IBZ (n=18) VAN (n=14) aggregate blinded data
Slide 7: Results: Demographics and Baseline Information
Results: Demographics and Baseline Information Demographics Baseline Ribotypes IBZ VAN P value Ribotype N N 16 14 F027 5 Age, years 64±13 62±10 0.57 F106 4 Female 13 (81%) 11 (79%) 0.85 F002 3 White 16 (100%) 13 (93%) 0.27 F014-020 3 Hispanic or Latino 11 (69%) 11 (79%) 0.54 F116 1 Charlson Comorbid
Slide 8: Initial, Sustained, and Extended Clinical Cure
Initial, Sustained, and Extended Clinical Cure Initial Clinical Cure Sustained Clinical Cure 100% 100% 90% 90% 80% 80% 70% 70% 60% 60% Percent (%) 50% 100% 50% 94% 94% 86% 40% 40% 30% 30% 20% 20% 10% 10% 0% 0% IBZ (n=16) VAN (n=14) IBZ (n=16) VAN (n=14) VAN Sustained Clinical Failure (n=2): RT 116 a
Slide 9: Microbiologic Eradication
Microbiologic Eradication 80% 73% 71% 70% IBZ VAN 60% 50% 40% IBZ: RT 106 VAN: RT Other VAN RT 027 VAN RT 106 VAN RT Other 30% 20% 10% 7% 8% 7% 7% 7% 0% 0% 0% 0% 0% 0% Baseline (15,14) Day 3 (15,13) Day 5 (16,14) Day 8 (11,14) Day 10 (15, 14) Day 12 (16, 13) IBZ: One patient with positive C. diffici
Slide 10: IBZ as effective as VAN for Time to Resolution of Diarrhea
IBZ as effective as VAN for Time to Resolution of Diarrhea Average Bristol score per day Cumulative incidence of UBM resolution UBM: unformed bowel movement Time to resolution of diarrhea defined as the time from onset of treatment to the first formed bowel movement not followed within the next 24 h
Slide 11: Safety
Safety IBZ VAN Drug-related Serious Adverse 0 0 Events Drug-related treatment 0 0 withdrawals Moderate adverse event, possibly 0 Headache (n=1) related Mild adverse event, possibly GERD (n=2) 0 related Nausea (n=1) All adverse events resolved without treatment
Slide 12: Discussion and Conclusions
Discussion and Conclusions • IBZ had a clinically comparable cure rates, TTRD, and safety profile to oral vancomycin. • More patients given vancomycin had persistently positive C. difficile cultured • Phase 2 experience (Ph2a+Ph2b): Of 26 CDI patients enrolled during IBZ phase 2 trials, 25 of 26 exp
Slide 13: Acknowledgements
Acknowledgements The Garey Lab Faculty GareyLab Funding M Jahangir Alam NIAID R01AI139261 Eugenie Basseres NIAID T32AI141349 Khurshida Begum NIAID PO1AI152999 Kevin W Garey Acurx Pharmaceuticals Anne J Gonzales-Luna Merck Pharmaceuticals Chenlin Hu Paratek Pharmaceuticals Jinhee Jo Seres Health Tary