- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
MGB Biopharma and FDA discuss MGB-BP-3 regulatory strategy
9 May 2016 • Author: Victoria White, Digital Content Producer
MGB Biopharma has held a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of MGB-BP-3 in the US.
MGB Biopharma presented available Phase I and preclinical data together with a proposal for the further clinical development of oral MGB-BP-3 in Clostridium difficile infections (CDI). Following this positive meeting, MGB Biopharma are now in the process of obtaining a designation of Qualified Infections Disease Product (QIDP) status for MGB-BP-3, and are starting to prepare for the clinical Phase II study.
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 the antibiotic is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of infectious hospital-acquired diarrhoea in developed countries.
Successful completion of the clinical Phase I study confirmed MGB-BP-3 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.
Commenting on the meeting, Dr Miroslav Ravic, CEO of MGB Biopharma, said, “We are extremely pleased with the support we have received from the FDA with regards to our plans to further progress the clinical development of oral MGB-BP-3. We are now planning to initiate a Phase II clinical trial and investigate the safety and efficacy of MGB-BP-3 in patients with CDI, caused by the most virulent ribotype of C. difficile known as C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.”
Dr Ravic added, “Our discussions with the FDA have provided clear guidelines on the development path we need to take to bring our truly novel antibiotic MGB-BP-3 to market in the shortest possible time. In parallel with our clinical development activities we are now evaluating partnering and funding sources for this exciting opportunity, which we believe will offer a clearly differentiated treatment option for patients with life threatening infections caused by resistant Clostridium difficile.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics