Combating worldwide bacterial resistance
The company is currently focusing on 505(b)(2) new dosage form product development of traditional antibiotics using our formulation and process expertise for site-specific delivery of drugs to bacteria locations.
Find an area of unmet need for antibiotics
Product development and proof of concept in animal model
According to Good Manufacturing Practice (GMP)
Conduct Phase 1 human clinical study and license out to commercial partners
Completed Pre-IND package of Metronidazole 505(b)(2) product for Clostridium difficile Infection and confirmed with the FDA on our study plan.
Received Qualified Infectious Disease Product (QIDP) designation for Metronidazole 505(b)(2) product, qualifying additional 5-year exclusivity.
Successfully completed in-vivo proof of concept studies of Metronidazole colon-targeting in canine model by imaging and pharmacokinetic studies.
US patent 10,588,864 entitled “Pharmaceutical Compositions for Colon-Specific Delivery”.
Up Next - Manufacture
GMP manufacturing in preparation for Fall 2020 and Phase 1 clinical study in preparation for Spring 2021.