FDA grants QIDP, Fast Track Designations to MCB3837
Morphochem, a clinical-stage pharmaceutical company, has announced that the FDA has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI). At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.
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 U.S. FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837,” said Thomas Kapsner, M.D., 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.
MCB3837 is a water-soluble injectable small-molecule prodrug of the active substance MCB3681, which is being developed for the IV treatment of CDI. Three phase I clinical studies have proved MCB3837/MCB3681 to be safe and tolerable. In preclinical studies, MCB3681 demonstrated remarkable Gram-positive antimicrobial activity against C. difficile pathogens including the highly virulent BI/NAP1/027 strain, with no cross-resistance to any established class of antibacterial.
In a multiple-dose phase Ib study with healthy volunteers, high fecal concentrations of MCB3681 were observed resulting in a pronounced effect on clostridia and other Gram-positive species while sparing Gram-negative species, including the bacteroides that protect the intestine against colonization with harmful pathogens potentially causing gastrointestinal infections. Due to this strong pharmacodynamic effect in humans, its narrow Gram-positive spectrum, and its favorable impact on the commensal flora, MCB3681 has the potential to target C. difficile pathogens selectively and effectively.