C Difficile Treatment Shows Positive Results in Phase 2 Study
CRS3123 is a novel, small molecule, antibiotic drug candidate that selectively inhibits 1 form of the bacterial methionyl-tRNA synthetase enzyme and is not affected by resistance to any existing classes of antibiotics.
Positive results have been announced from a phase 2 trial evaluating the safety and efficacy of CRS3123 in adult patients with a primary episode or a first recurrence of clostridioides difficile infection (CDI), biopharmaceutical company Crestone announced in a release.1
C Difficile Treatment Shows Positive Results in Phase 2 Study / Ratchadaporn - stock.adobe.com
Data from the phase 2 trial (NCT04781387) showed that CRS3123 met its primary endpoint of rate of clinical cure at test of cure (TOC) in the intention to treat group. The therapy was also seen to be well tolerated, with no serious adverse events observed during the study. Crestone said it intends to present the data at an upcoming conference.
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CRS3123 is a novel, small molecule, antibiotic drug candidate and has demonstrated narrow spectrum and minimal disruption of normal gut microbiota. The therapy selectively inhibits 1 form of the bacterial methionyl-tRNA synthetase enzyme and is not affected by resistance to any existing classes of antibiotics. It was previously granted Qualified Infectious Disease Product and Fast Track designations by the FDA.2
“Treatment of C. difficile infection remains in urgent need of agents that spare normal gut microbes, so they can reconstitute the microbiome and prevent further recurrences of CDI,” Thomas Louie, principal investigator on the study, said in a release.1 “The findings of this study support CRS3123 as such a candidate for further development.”
The randomized, double-blind, comparator-controlled, multicenter phase 2 study evaluated safety and efficacy of CRS3123 in adult patients with a primary episode or first recurrence of CDI. The study included 100 patients aged 18 or older who tested positive for C. difficile toxin A and/or B antigen via an approved laboratory test.
Participants received either CRS3123 200 mg or 400 mg administered twice daily, or vancomycin 125 mg administered 4 times daily for 10 days. The primary endpoint was defined as the rate of clinical cure at day 12. Key secondary endpoints included rates of recurrence and global cure, time to resolution of diarrhea, and the effect of the therapy on commensal bacteria in the gut.
The study found that the clinical cure rate at the day 12 test-of-cure visit was 97% for patients who received either dose of CRS3123, compared to 93% in the vancomycin group. There were no clinical failures observed. Rates of CDI recurrence were also considerably lower in patients who received CRS3123, with rates of 4% for CRS3123 and 23% for vancomycin at day 40.
Crestone said in the release the National Institute of Allergy and Infectious Diseases (NIAID) exercised an option under an existing agreement to provide $4.5 million in new funding to the company. The money will be used for microbiome analyses, manufacturing process optimization and other phase 2 supporting studies. The initial agreement, announced in 2019, was for a total of up to $17.8 million.3
“We very much appreciate NIAID’s scientific input and the more than $28 million in funding for phase 2 development of CRS3123,” Urs Ochsner, PhD, co-Founder, vice president of R&D and CEO at Crestone, said in a release.1 “With these topline data and further data to come in the next few months, we look forward to discussions with the FDA and prospective development partners and investors about accelerating into pivotal CDI studies with CRS3123.”
READ MORE: Infectious Disease Resource Center
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