BOULDER, Colo.–(BUSINESS WIRE)–Crestone, Inc., today announced a Contract Award from the National Institutes of Health focused on the Phase 2 clinical development of its small molecule drug candidate, CRS3123, for the treatment of Clostridioides difficile infections (CDI). Under this contract, the safety and efficacy of CRS3123 will be evaluated for the first time in patients with CDI.
CDI is the most common hospital-acquired infection in the U.S. with an estimated 500,000 cases per year, which are associated with 29,000 deaths within 30 days of diagnosis. CDI is the leading cause of antibiotic-associated diarrhea among hospitalized patients and is becoming more prevalent in the community, including in younger patients. Currently, most patients are treated with suboptimal, broad-spectrum antibiotics that prevent healthy gut microbiota from recovering, contributing to CDI recurrence rates of 20-40%.
The Phase 2 trial will be randomized and double-blinded and will include three ten-day treatment arms of twice-daily doses of 200 mg or 400 mg CRS3123 compared to vancomycin 125 mg four times per day. Patients with clinically documented CDI will be enrolled at approximately 30 sites in the U.S. The primary endpoints will be clinical cure rate and time to resolution of symptoms. Secondary and exploratory endpoints include recurrence rate, global cure rate and the effect of CRS3123 on commensal bacteria in the gut.
“We are excited to initiate the Phase 2 trial of CRS3123, a narrow-spectrum agent that is highly selective for the target pathogen with minimal disruption of healthy gastrointestinal microbiota. In addition to its antibacterial action, CRS3123 blocks the production of the disease-causing toxins and the formation of spores associated with recurrence,” said Urs Ochsner, co-Founder and Vice President of R&D at Crestone, who will serve as the Principal Investigator on the study.
Funding for this trial will be provided entirely by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) under Contract No. 75N93019C00056 for a total of up to $17.8 million including the base period and subsequent option periods.
CRS3123 is a novel small molecule that selectively inhibits methionyl-tRNA synthetase of C. difficile and is not affected by resistance to any existing classes of antibiotics. As a protein synthesis inhibitor, CRS3123 also inhibits C. difficile toxin production and spore formation. CRS3123 has been evaluated in Phase 1 trials to determine its safety and tolerability in healthy subjects following single or multiple oral doses. CRS3123 was generally safe and well tolerated with no significant treatment-emergent adverse events reported and showed minimal perturbation of normal intestinal microbiota.
About Crestone, Inc.
Boulder, Colorado-based Crestone, Inc. is a clinical stage biopharmaceutical company focused on inventing and developing novel mechanism of action small molecule drugs for serious bacterial infections including CDI, resistant Gram-positive infections such as MRSA and VRE, and nontuberculous mycobacteria (NTM).