KamTek granted patent for activity of Clofazimine against C. difficile
In a ground breaking discovery, researchers at KamTek observed that Clofazimine had excellent activity against Clostridium difficile, especially against its resistant strains. Further, it had a synergistic effect in combination with metronidazole and demonstrates ability to differentially kill C. difficile, while barely affecting many other ‘friendly’ gut microbes. KamTek has been granted a US patent (US 20170143707 A1) by the US Patent and Trademark Office for this discovery. The title of patent being “Synergistic clofazimine/metronidazole combination for treating Clostridium difficile”.
Another patent (15/831,237) application from KamTek with title “Pharmaceutical compositions containing clofazimine for inhibiting Clostridium difficile activity” has been recently granted as U.S. Patent No. 10,064,860 to KamTek, Inc. in September 2018.
U.S. Centers for Disease Control and Prevention (CDC) has classified C. difficile infections (CDI) as an “Urgent Public Health Threat” and FDA has included C. difficile in its register as “qualifying pathogens” for priority research under Generating Antibiotic Incentives Now (GAIN) Act. KamTek was partially funded by the National Institute of Health under SBIR program for in vivo efficacy studies of Clofazimine against C. difficile associated disease (CDAD) in Hamster Model. It has now drawn ambitious plans to develop new Clofazimine formulation ‘EK101’ for thorough INDA enabling studies on animals, submit these findings for a fast track approval by FDA and commercialize the drug as QIDP for its new indication.