Acurx Pharmaceuticals, Inc. · NASDAQ:ACXP
Acurx Pharmaceuticals — IDWeek 2019
13 slides from Acurx Pharmaceuticals's conference presentation, 2019
Slide 1: Phase 1 Study of ACX-362E Administered Orally to Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Determine the Safety, Pharmacokinetics, Food, and Fecal Microbiome Effects of ACX-362E Administered Orally to Healthy Subjects Kevin W. Garey, PharmD, MS, FASHP Professor and Chair Dept of Pharmacy Pr
Slide 2: Acknowledgements
Acknowledgements • Funding provided by Acurx Pharmaceuticals
Slide 3: ACX-362E
ACX-362E Acurx Pharmaceuticals ACX-362 dGTP • Small-molecule inhibitor of DNA Pol IIIC enzyme based upon competitive inhibition of dGTP • DNA Pol IIIC • essential for replication of low G+C content Gram-positive bacteria • Pol IIIC active-site domain incorporates a unique pocket which renders it spe
Slide 4: ACX-362E has in vitro/in vivo activity against Clostridioides difficile
ACX-362E has in vitro/ in vivo activity against Clostridioides difficile In vitro susceptibility against 96 clinical isolates Effectiveness in a Syrian hamster model 362E MTX VAN FDX MIC 0.5-8 0.25 - >32 0.5-16 0.03- >8 range MIC50 2 0.5 1 0.5 MIC90 4 4 4 2 MTZ; metronidazole; VAN: vancomycin; FDX:
Slide 5: ACX-362E: First in human, phase I clinical trial
ACX-362E: First in human, phase I clinical trial • Primary: To determine safety of ACX-362E in both single- and multiple-dose administration to healthy subjects • Secondary: To determine, in both single- and multiple-dose administration: • Systemic pharmacokinetics (PK) of ACX-362E; • Fecal PK of AC
Slide 6: Randomized, placebo controlled, 3-part study design
Randomized, placebo controlled, 3-part study design Part 1 Part 2 Part 3 Multiple, ascending dose Design Single-ascending dose Food effect crossover (MAD) Treatment days 1 dose 1 dose 10 days (20 doses) Dose cohort 150, 300, 600, 900 mg 300 300, 450 mg N 6/cohort 8 6 Vancomycin (n=6) Comparator (n=)
Slide 7: Safety
Safety Proportion of subjects with any adverse event (AE) in each Description of adverse events from MAD study* study period Number of DOSE (mg BID x 10 D) AE DESCRIPTION INTENSITY SCALE Single ascending dose Food effect Multiple ascending dose events 300 COUGH 1 MILD (GRADE 1) CYSTITIS-NON ACX-362E
Slide 8: Plasma Pharmacokinetics
Plasma Pharmacokinetics Single ascending dose Multiday ascending dose Food effect (ACX-362E 300 mg) Day 1 Day 6 Day 10
Slide 9: Stool pharmacokinetics
Stool pharmacokinetics Multiday ascending dose Single ascending dose Food effect (ACX-362E 300 mg)
Slide 10: Metagenomics: Differential abundance & beta diversity
Metagenomics: Differential abundance & beta diversity Day 0 Day 5 Day 10 P=0.2 P=0.006 P=0.70 P=1.0 P=0.70 P=1.0 P=0.006 P=0.66 P=1.0
Slide 11: Microbiome analysis (qPCR): Microbiota levels belonging to different taxonomic groups
Microbiome analysis (qPCR): Microbiota levels belonging to different taxonomic groups Bacteroides C. leptum Enterobacteriaceae Prevotella C. coccoides Eubacteria
Slide 12: Conclusions: ACX-362E Phase I Clinical Trial
Conclusions: ACX-362E Phase I Clinical Trial • No safety signals observed • AEs were well tolerated, similar to placebo, and transitory • Ideal pharmacokinetics for a C. difficile antibiotic • Low systemic concentrations below 1 ug/mL • Fecal levels several fold higher than the MIC of C. difficile (
Slide 13: Acknowledgements
Acknowledgements Acurx Pharmaceuticals Michael H Silverman, MD; Acurx Pharmaceuticals LLC, White Plains, NY, USA Anne Gonzales-Luna, PharmD; Univ of Houston College of Pharmacy, Houston, TX, USA M Jahangir Alam, PhD; Univ of Houston College of Pharmacy, Houston, TX, USA Khurshida Begum, PhD; Univ of