BOULDER, Colo.--(BUSINESS WIRE)--Crestone, Inc. today announced the first patient has been enrolled in a Phase 2 clinical trial of CRS3123 for the treatment of Clostridioides difficile infection (CDI). CRS3123 is a novel small molecule antibiotic drug candidate that has demonstrated narrow spectrum and minimal disruption of normal gut microbiota in preclinical and Phase 1 studies. The company also announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to CRS3123 for the treatment of CDI.
About the Phase 2 Study
“We are delighted to begin enrolling patients to test this promising novel antibiotic. In addition to its narrow spectrum, CRS3123 also blocks the production of the disease-causing toxins and the formation of spores associated with recurrence,” said Dr. Jon Bruss, Chief Medical Advisor to Crestone, Inc.
The Phase 2, randomized, double-blind, comparator-controlled, multicenter study will evaluate safety and efficacy of two dosages of CRS3123 (200 mg and 400 mg) administered twice-daily compared with vancomycin 125 mg administered four times daily in approximately 100 adults 18 or older diagnosed with a primary episode or first recurrence of CDI. The duration of treatment for all study treatment arms is 10 days. Patients with clinically documented CDI will be enrolled at up to 30 sites in the U.S and Canada. The primary endpoint will be rate of clinical cure at day 12. Secondary and exploratory endpoints include rates of recurrence and global cure, time to resolution of diarrhea and the effect of CRS3123 on commensal bacteria in the gut.
Dr. Tom Louie of University of Calgary, Canada, is lead investigator for this study. The study will also be supported by epidemiology and toxin testing at University of Leeds, England. This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93019C00056 for up to $20 million.
About QIDP and Fast Track Designations
The GAIN Act of 2012 created the QIDP program to incent innovation for the most serious infectious diseases, including CDI. During clinical development of CRS3123, QIDP designation will facilitate and accelerate FDA interactions through FDA’s Fast Track and Priority Review programs. Upon FDA approval, QIDP status will also provide an extra five years market exclusivity under the Hatch Waxman Amendments to the Food, Drug and Cosmetic Act.
“We believe CRS3123 is a good example of the kind of innovation the GAIN Act sought to encourage,” said Urs Ochsner, PhD, co-Founder, Vice President of R&D and CEO at Crestone. “CDI patients desperately need improved therapy options in order to reduce the serious problem of CDI recurrence. We appreciate the ways FDA’s QIDP and Fast Track programs will help us to accelerate toward approval of CRS3123,” said Dr. Ochsner.
About C. difficile Infection
CDI is the most common hospital-acquired infection in the U.S. It is the leading cause of antibiotic-associated diarrhea among hospitalized patients and in recent years has become much 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%. Once CDI recurs, it is more likely to recur again and again even after further treatment, leading to substantially increased morbidity and mortality.
CRS3123 represents a novel class of antibiotic and is not affected by resistance to any existing classes of antibiotics. It is a small molecule that selectively inhibits one form of the bacterial methionyl-tRNA synthetase enzyme. This target is not present in human cells, nor in other important bacterial species that are part of the normal microbiota of the gut. As a protein synthesis inhibitor, CRS3123 inhibits C. difficile toxin production and spore formation. In Phase 1 trials in healthy subjects following single or multiple oral doses, CRS3123 was generally safe and well tolerated with no significant treatment-emergent adverse events reported. It also showed minimal perturbation of normal intestinal microbiota in Phase 1.
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. Its pipeline includes antibacterial agents to treat CDI, resistant Gram-positive infections such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), and chronic infections such as nontuberculous mycobacterial (NTM) disease.
Crestone, Inc. enrolls first patient in Phase 2 clinical trial for novel antibiotic CRS3123 to treat C. difficile infections. Also, FDA grants CRS3123 ‘Qualified Infectious Disease Product’ (QIDP) and ‘Fast Track’ designations.
July 1, 2020. Crestone, Inc. Secures NIH Funding for Development Through Phase 1 of Novel Antibiotic Candidate CRS0540, A Novel Inhibitor of DNA Replication in Gram-positive Pathogens.
May 29, 2020. Crestone, Inc. receives $250,000 Grant from State of Colorado Advanced Industries Accelerator program
April 27, 2020. Crestone, Inc. Secures NIH Funding for Preclinical Development of Novel Antibiotic CRS3123 to Treat H. pylori Infections.