FDA grants QIDP and fast track designation for Morphochem’s CDI treatment

25 July 2016 (Last Updated July 25th, 2016 18:30)

The US Food and Drug Administration (FDA) has designated German-based pharmaceutical company Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) to treat Clostridium difficile infection (CDI).

The US Food and Drug Administration (FDA) has designated German-based pharmaceutical company Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) to treat Clostridium difficile infection (CDI).

The FDA has additionally granted fast track designation to the compound’s development programme for the treatment of CDI.

MCB3837 is a water-soluble, injectable small-molecule prodrug of the active substance MCB3681, which is an antibacterial being developed for the IV treatment of CDI, a serious and life-threatening disease.

Clostridium difficile (C. difficile) is a gram-positive bacterium that results in serious gastrointestinal infections.

The bacterium produces toxins that cause inflammation of the colon and severe diarrhoea, and in some cases the disease can be fatal.

Morphochem chief executive officer Dr Thomas Kapsner said: “After the US FDA’s acceptance of Morphochem’s IND in June, we are glad to have now received both QIDP and Fast Track designation for MCB3837.

"By providing an effective IV therapy, we aim to improve the prospects and quality of life of these patients."

“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.”

The QIDP designation, obtained under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, offers certain incentives for the development of new antibacterial drug products.

The German pharmaceutical company intends to begin a proof-of-concept Phase II clinical trial of MCB3837/3681 in patients suffering from severe CDI in the second half of this year.


Image: Drumstick-shaped C. difficile bacilli seen through scanning electron microscopy. Photo: courtesy of CDC / Lois S. Wiggs.