The FDA has designated Morphochem’s MCB3837 as a Qualified Infectious Disease Product (QIDP) and simultaneously put the antibiotic on its regulatory fast-track program. The regulatory rulings give Morphochem the opportunity to liaise more frequently with the FDA at a time when it is gearing up for the start of a Phase II trial.
Morphochem is developing MCB3837 as an intravenous treatment for Clostridium difficile infections (CDI). The asset, a small molecule that is converted into the active substance MCB3681 in the body, has come through three Phase I trials and various preclinical tests to date, resulting in a data set the FDA saw as sufficiently compelling to designate MCB3837 as a QIDP and immediately put it on its fast track. QIDP status makes a product eligible for the fast track, but only some drugs receive both statuses at the same time.
The simultaneous regulatory boosts come at an important moment in the 20-year history of Munich, Germany-based Morphochem. Last month, the FDA accepted an IND for MCB3837, setting Morphochem up to start a proof-of-concept trial in severe CDI patients before the end of the year. Morphochem is hoping the Phase II trial will add to evidence that MCB3837 is a safe, tolerable treatment that acts against C. difficile pathogens without affecting Gram-negative species of bacteria. In preclinical, Morphochem saw no cross-resistance to existing types of antibacterials.
The FDA’s willingness to grant MCB3837 regulatory privileges is testament to the problems CDIs are posing to the healthcare system. The U.S. Centers for Disease Control and Prevention (CDC) estimates that in 2011 the U.S. saw 500,000 C. difficile infections. Of these patients, 29,000 are thought to have died with a month of being infected. With no intravenous treatment approved for use in this patient population, the FDA is open to accelerating MCB3837’s path to market, provided Morphochem can deliver the necessary data.
Morphochem is hoping the FDA won’t be the only organization interested in its data. Last month the company revealed it had retained Torreya Partners to support its partnering efforts. Landing a deal would mark a milestone in the long, somewhat convoluted history of Morphochem. Having set up shop in 1996, Morphochem bought U.S.-based Small Molecule Therapeutics four years later for its screening tools. At that time, Morphochem wasn’t focused on antibiotics. In 2006, Morphochem was itself bought by Intercell spinout Biovertis.
Now, Morphochem exists as a fully owned subsidiary of Biovertis, a Vienna, Austria-based company that is bankrolled by TVM Capital.
- read the release
Merck faces FDA delay for C. diff antibody amid trial data concerns
Merck lines up for a quick approval with its C. diff therapy
Roche gets FDA green light for quick C. difficile test
Scientists take a step closer to developing vaccine against C. difficile