BOULDER, Colo.--(BUSINESS WIRE)--Crestone, Inc. today announced a grant award from the National Institutes of Health for the preclinical evaluation of its antibiotic candidate CRS3123 to treat infections caused by Helicobacter pylori. CRS3123 is also entering a phase 2 clinical study for treatment of Clostridioides difficile infections under a separate NIH contract with Crestone.
H. pylori is a bacterium known to be present in the stomachs of more than half the people in the world. Complications associated with H. pylori infection occur in about 10% of people and include gastritis, ulcers or stomach cancer. In fact, the pathogen causes over half a million stomach cancers worldwide per year and has become increasingly resistant to treatment with antibiotics, particularly in China and Japan. The WHO has classified H. pylori as a class I carcinogen and recently listed drug-resistant H. pylori as a priority pathogen.
Under this grant from NIH, Crestone’s drug candidate CRS3123 will be tested for pharmacokinetic properties and efficacy in an established preclinical model of H. pylori infection of the stomach. CRS3123 will be compared to standard triple or quadruple drug therapy, with or without the addition of proton pump inhibitor to reduce stomach acid.
“Potent antibiotics with a novel mode of action and a good safety profile are sorely needed to augment the armamentarium of H. pylori drugs, and CRS3123 has already demonstrated excellent potency against this pathogen, including drug-resistant strains,” said Urs Ochsner, PhD, co-Founder and Vice President of R&D at Crestone.
Funding for these preclinical studies will be provided entirely by NIH’s National Institute of Allergy and Infectious Diseases under Grant No. R43AI149820.
CRS3123 is a novel small molecule that selectively inhibits methionyl-tRNA synthetase and is not affected by resistance to any existing classes of antibiotics. As a protein synthesis inhibitor, CRS3123 also inhibits the production of toxins, which are the key virulence factors of pathogens such as C. difficile and H. pylori. CRS3123 has already been evaluated in Phase 1 trials to determine its safety and tolerability in healthy subjects following single or multiple oral doses. A Phase 2 clinical trial to evaluate the safety and efficacy of CRS3123 in patients with C. difficile infection has been funded through a multi-year contract from NIH and is in the start-up phase.
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 Clostridioides difficile infection (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.