CDI has been recognised as an urgent threat pathogen by the Centers for Disease Control and Prevention in the US and is a common consequence of antibiotic treatment in hospitalised patients. MGB-BP-3 has received Qualified Infectious Disease Product (QIDP) status from the FDA, enabling Fast Track submission and 5 years of extended marketing exclusivity.
In contrast to vancomycin and fidaxomicin, MGB-BP-3 will be eligible to participate in the DISARM programme of prescribing incentives being considered in the United States which will increase patient access to new and innovative treatments.
Dr Miroslav Ravic, CEO of MGB Biopharma, said: “We are delighted to have succeeded in meeting our endpoints in this Phase II trial, which is a significant milestone for MGB Biopharma. This study managed to identify a dose that provides a fine balance between maximal killing effects against C. difficile whilst having a minimal effect on the remaining normal gut flora. This results in a very high initial cure rate and reduction of disease recurrence.
“As the recent COVID-19 pandemic has demonstrated, the world urgently needs new anti-infective treatments so we can be better prepared for new threats. MGB-BP-3 would bring a new, vastly improved paradigm to the treatment of CDI which would reduce the morbidity and mortality caused by this dreadful infection.”
Dr Sarah Hardy, Director, Archangels, said: “Developing new treatments is a key part of the global effort against superbugs. We’re proud to have supported MGB Biopharma to take on this debilitating disease and we look forward to watching its performance in Phase III trials ahead of it being made available to the clinicians who are battling CDI on a daily basis.”
Kerry Sharp, Director, Scottish Investment Bank, said: “This is great news for MGB Biopharma and a significant development in the ongoing global fight against antibiotic-resistant infections. It’s never been more important to support pioneering companies developing new and better medicines with the potential to save lives.”