ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection

Summary

Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E \[ibezapolstat\] in patients with C. difficile infection (CDI).

Timeline

Start

2020-03-06

Primary completion

2023-10-03

Completion

2023-11-15

Publications

• Background Xu WC, Silverman MH, Yu XY, Wright G, Brown N. Discovery and development of DNA polymerase IIIC inhibitors to treat Gram-positive infections. Bioorg Med Chem. 2019 Aug 1;27(15):3209-3217. doi: 10.1016/j.bmc.2019.06.017. Epub 2019 Jun 11.
• Background Dvoskin S, Xu WC, Brown NC, Yanachkov IB, Yanachkova M, Wright GE. A novel agent effective against Clostridium difficile infection. Antimicrob Agents Chemother. 2012 Mar;56(3):1624-6. doi: 10.1128/AAC.06097-11. Epub 2011 Dec 27.
• Background Garey KW, Begum K, Lancaster C, Gonzales-Luna A, Bui D, Mercier J, Seng Yue C, Ducharme MP, Hu M, Vince B, Silverman MH, Alam MJ, Kankam M. A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects. J Antimicrob Chemother. 2020 Dec 1;75(12):3635-3643. doi: 10.1093/jac/dkaa364.
• Results Garey KW, McPherson J, Dinh AQ, Hu C, Jo J, Wang W, Lancaster CK, Gonzales-Luna AJ, Loveall C, Begum K, Jahangir Alam M, Silverman MH, Hanson BM. Efficacy, Safety, Pharmacokinetics, and Microbiome Changes of Ibezapolstat in Adults with Clostridioides difficile Infection: A Phase 2a Multicenter Clinical Trial. Clin Infect Dis. 2022 Sep 30;75(7):1164-1170. doi: 10.1093/cid/ciac096.
• Results Eubank TA, Alam MJ, Begum K, McPherson JK, Jo J, Silverman MH, and Garey KW. A phase 2b, randomized double-blind study of ibezapolstat compared with vancomycin for the treatment of C. difficile infection: clinical and microbiome evaluation. Poster session presented at: IDWeek 2024; 2024 October 16-19; Los Angeles, CA.
• Results Garey KW, Alam MJ, Begum K, McPherson JK, Eubank TA, Jo J, and Silverman MH. Microbiome Results from the phase 2, randomized, double-blind study of ibezapolstat compared with vancomycin for the treatment of Clostridioides difficile infection. Slide presentation at: 8th International Clostridioides difficile Symposium; 2024 September 17-19; Bled, Slovenia.
• Eubank TA, Jo J, Alam MJ, Begum K, McPherson JK, Le TM, Horvath TD, Haidacher SJ, Poggio EC, Lin R, Yue CS, Ducharme MP, Koudssi G, Mercier J, Alder JD, Silverman MH, Garey KW; Ibezapolstat Phase 2 Investigator Group. Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomised, double-blind, active-controlled, multicentre study. Lancet Microbe. 2025 Aug;6(8):101126. doi: 10.1016/j.lanmic.2025.101126. Epub 2025 Jun 11.

Drugs

Indications