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GLASGOW, Scotland, Jan. 27, 2021 /PRNewswire/ MGB Biopharma , a biopharmaceutical company developing MGB-BP-3, a novel antibacterial, for the treatment of Clostridioides difficile (CDI), today announces the successful completion of its End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA), an important milestone for the company and its lead product. The EOP2 Meeting is a formal step at which companies seek confirmation that their product is considered safe to proceed to broader clinical studies, and to explore any additional studies that may be required before entering into Phase 3. At the meeting, the US FDA confirmed that the design and the endpoints of our two prospective Phase 3 studies were appropriate. The Phase 3 studies, which are expected to recruit approximately 900 patients, will include superiority of MGB-BP-3 against vancomycin in the critical measure of sustained clinical response as one of their endpoints.

Glasgow cityUnited kingdomMiroslav ravicThomas louieChris wardhaughSylvie berrebiCitigate dewe rogersonScottish investment bankCenters for diseaseUniversity of albertaCumming school of medicineDrug administrationUniversity of strathclydeSyndicate roomArchangel investorsSustained cure