C Diff. Prevention Candidate Heads Into Clinic With Ambitious Timetable
This article was originally published in Pharmaceutical Approvals Monthly
Synthetic Biologics thinks it can produce first product to prevent C. difficile infections by protecting microbiome from impact of I.V. beta lactam antibiotics; biotech plans IND in next two months and hopes to produce proof-of-concept data within roughly one year.
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Big Pharma may have abandoned anti-bacterial research some years ago, but biotechs are filling the void. Their approaches range from improving existing drugs to discovering entirely new targets. Yet although a handful in Europe, including recently floated Basilea and private firm Arrow, has attracted recent investor interest, it hasn't been the anti-bacterials per se that have drawn them in. Basilea benefited from its spin-off status; Arrow from a promising anti-viral project and broad portfolio. Despite growing concerns over bacterial resistance, the field needs success stories to draw investors back for good. Even then, the nature of the diseases and therapies under development mean it's likely to remain the domain of smaller firms.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.