Phase IIa Clinical Trial for a Novel Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

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MGB Biophamra propose conducting a Phase IIa study to confirm the safety, tolerability and efficacy of MGB-BP-3 in patients with Clostridium difficile-associated diarrhoea (CDAD). The US CDC has designated C. difficile as an urgent threat, as it affects almost half a million people annually in the US alone, with a high annual mortality rate of around 30,000. The incidence of CDAD in the EU is estimated to be similar to the US, although there are no collective data. The major unmet medical need of current CDAD therapy is the very high recurrence rate after initial treatment and the low cure rate caused by the hypervirulent ribotype BI/NAP1/027. MGB-BP-3 has shown overwhelmingly superior bactericidal activity over vancomycin against all C. difficile strains investigated in all preclinical tests performed, including this hypervirulent ribotype. GlobalData reports that the market size for the treatment of CDAD is estimated to grow to over $1 bn in the US alone, making MGB-BP-3 a potentially multibillion dollar drug. At our PIND meeting with the FDA we proposed an integrated, fast track clinical development plan for MGB-BP-3. The FDA supported this and accepted our Phase II study design. The proposed Phase IIa study will select the dose/schedule with the best tolerability and efficacy for the randomised, comparative Phase IIb study against vancomycin in CDAD patients with the BI/NAP1/027 ribotype. The FDA has agreed that we only need to conduct one pivotal Phase III study for NDA filing. MGB-BP-3 has the potential of being the new standard of care for CDAD, on successful completion of clinical development.