11th Nov 2015 10:58
LONDON (Alliance News) - Biopharmaceutical company Motif Bio PLC on Wednesday said it has received written advice in relation to the phase 3 clinical development programme for its antibiotic designed to fight multi-drug-resistant bacteria.
The advice from a Scientific Advice Meeting with the Medicines Evaluation Board in Utrecht, in the Netherlands confirmed two phase 3 clinical trials and microbiological data from the planned surveillance studies into the drug will be acceptable as registration studies in the European Union regulatory process for the treatment.
"With MEB acceptance of our proposal for two Phase III clinical trials for iclaprim, Motif remains firmly on track to meet its goal of completing the two ABSSSI trials in 2017, and submitting a Marketing Authorisation Approval in Europe," said Chief Medical Officer David Huang.
Motif shares were down 0.9% to 58.00 pence on Wednesday.
By Sam Unsted; [email protected]; @SamUAtAlliance
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