FDA grants QIDP and Fast Track designations to MCB3837

Morphochem’s novel intravenous antibacterial to treat C. difficile infections.

Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, the QIDP designation provides certain incentives for the development of new antibacterial drug products, such as priority review and additional five years of marketing exclusivity granted at the time of marketing approval. The Fast Track designation enables more frequent interactions with the FDA, often leading to earlier drug approval and access for patients.

“After the FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837,” says Thomas Kapsner, Morphochem’s Chief Executive Officer. “These designations will help us to expedite the development of this promising IV compound for the many severely ill CDI patients who cannot be treated orally. By providing an effective IV therapy, we aim to improve the prospects and quality of life of these patients.”

Morphochem is planning to initiate a proof-of-concept Phase II clinical trial of MCB3837/3681 in severe CDI patients in H2 2016.