Glasgow, Scotland, 28th January 2019 – MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces today that the US Food and Drug Administration (FDA) has granted the tablet presentation of MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP), and Fast Track designation for the Treatment of Clostridium difficile-associated Diarrhoea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.
MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of cases of infectious hospital-acquired diarrhoea in developed countries.
Successful completion of the clinical Phase I study of MGB-BP-3 confirmed the compound was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora. MGB has initiated a Phase IIa clinical study for MGB-BP-3 to investigate the safety, tolerability and efficacy in patients with CDAD.
While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.
The QIDP designation program was established by the U.S. Congress in 2012 as part of the Generating Antibiotic Incentives Now (GAIN) Act in order to provide incentives to drug manufacturers to develop new antibiotics for serious, antibiotic-resistant, bacterial and fungal infections. QIDP also paves the way for FDA to apply greater regulatory flexibility in the case of high unmet medical need for serious, life-threatening infections. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.