Synthetic Biologics, Inc. (SYN) announced the commencement and dosing of the first patient in a randomized, double-blind, placebo-controlled phase Ib study on its oral investigational candidate, SYN-004.
The company is evaluating SYN-004 for the prevention of Clostridium difficile infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients undergoing intravenous (IV) beta-lactam antibiotic therapy.
In the phase Ib study, Synthetic Biologics will evaluate the safety, tolerability and pharmacokinetics of multiple-ascending oral doses of SYN-004 versus placebo in up to 24 healthy volunteers. Top-line data from the phase Ib study should be out in the first quarter of 2015. Additionally, the company intends to commence patient enrollment in a phase II study on SYN-004 in this setting during the same period.
Data from IMS Health and the U.S. Department of Health & Human Services reveal that every year nearly 1.1 million patients in the U.S. suffer from Clostridium difficile infection with 30,000 patients dying from the disease. According to Synthetic Biologics, there are no approved therapies for the protection of the microbiome from the damaging effects of IV antibiotics. Given that approximately 24 million people in America undergo IV antibiotic treatment every year, we believe there is an urgent need for treatments designed to prevent the development of and severe effects from hospital-acquired infections occurring as a result of treatment with IV antibiotics.
Notably, Actelion (ALIOF) has a late-stage candidate, cadazolid, which is being developed for the treatment of Clostridium difficile-associated diarrhea. Results from a phase III study on the candidate should be out in 2016. Cadazolid enjoys Qualified Infectious Disease Product designation in the U.S. along with fast track status.
Synthetic Biologics carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Regado Biosciences, Inc. (RGDO) and The Medicines Company (MDCO). Both carry a Zacks Rank #1 (Strong Buy).
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