Development is progressing well
Our compound MCB3681 is a small-molecule antibacterial of a new class. It is targeted at the intravenous therapy of severe CDI—the first to undergo clinical development and pursue regulatory approval in the United States and Europe.
In pre-clinical studies, MCB3681 has demonstrated remarkable Gram-positive antimicrobial activity. It was particularly effective against C. diff clinical isolates (N = 335), regardless of both their virulence—including hypervirulent NAP1—and their resistance to other antibacterials. We detected no cross-resistance to any established class of antibacterials. (See our Downloads and Links section for further details.)
Due to its narrow Gram-positive spectrum and favorable impact on the commensal flora, MCB3681 has the potential to target C. diff bacteria selectively and provide a cure for severely ill CDI patients.
At present we are preparing a Phase 2 study for intravenous administration of MCB3837 to patients diagnosed with severe CDI. The study is planned to start in the second half of 2016.
European authorities are considering similar supportive measures to accelerate the development of antibiotics addressing unmet medical needs.
*GAIN is short for Generating Antibiotics Incentives Now. The GAIN Act forms part of the Food and Drug Administration Safety and Innovation Act, FDASIA.