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Our Focus

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.

Our Pipeline

Identify

Find an area of unmet need for antibiotics

Study

Product development and proof of concept in animal model

Manufacture

According to Good Manufacturing Practice (GMP)

Clinical

Conduct Phase 1 human clinical study and license out to commercial partners

Our Timeline

Pre-IND

March 2017

Completed Pre-IND package of Metronidazole 505(b)(2) product for Clostridium difficile Infection and confirmed with the FDA on our study plan.

Market Exclusivity

February 2018

Received Qualified Infectious Disease Product (QIDP) designation for Metronidazole 505(b)(2) product, qualifying additional 5-year exclusivity.

Canine Model

October 2019

Successfully completed in-vivo proof of concept studies of Metronidazole colon-targeting in canine model by imaging and pharmacokinetic studies.

Patent Granted

March 2020

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.

Fall 2020

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