MGB Biopharma has announced promising phase IIa clinical trial update for oral formulation MGB-BP-3, a potent oral bactericidal antibiotic targeting Clostridium Difficile-Associated Diarrhoea (CDAD), with – as it said in a press release – a completely novel mode of action.
MGB Biopharma’s ongoing Phase IIa trial is assessing the safety, tolerability and efficacy of incremental doses of MGB-BP-3 in patients with CDAD, with the cure rate assessed after completion of 10-day therapy and at follow-up of up to 8 weeks. In addition to its primary endpoints the study will also assess the impact of MGB-BP-3 on the microbiome.
Headline results from all three cohorts are anticipated in early 2020, the company said.
Furthermore, it said that, to date, MGB-BP-3 is the only antibiotic that has the killing power, combined with the speed of action, to eradicate C. difficile within the first few hours of exposure, helping to prevent the bacteria evading therapy via sporulation. Importantly, MGB-BP-3 has very strong bactericidal activity against the BI/NAP1/027 strain, the most virulent strain of C. difficile, which is largely resistant to current therapy.
CDAD is a serious and life-threatening infection of the large intestine and is the most frequent cause of diarrhoea in hospitals and care homes. In the US alone there are almost half a million cases every year leading to around 30,000 deaths per annum.
Dr Miroslav Ravic, CEO of MGB Biopharma, said: “We are delighted to have completed the first of three patient cohorts in our Phase IIa study. As this is an open-label study, we are able to see how the drug performs on an ongoing basis and are encouraged by what we have seen so far. Given its unique properties, we remain confident that MGB-BP-3 could represent a new paradigm for the treatment of CDAD, a potentially life-threatening infection.”