Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Early last week, Synthetic Biologics, Inc.’s (SYN) announced positive results from the first safety and tolerability review in a randomized, double-blind, placebo-controlled phase Ia 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 Ia study, one dose of SYN-004 (increasing dose levels by cohort) is being studied in 24 healthy volunteers in three cohorts, in comparison with placebo.
Based on these results, Synthetic Biologics intends to advance SYN-004 to a multiple-ascending dose placebo-controlled phase Ib study in healthy volunteers who will receive increasing doses of SYN-004 over several days. Patient enrollment in this study is expected to begin by year end. Top-line data from the study should be out in the first quarter of 2015.
Meanwhile, Synthetic Biologics is working toward the development of its pipeline. The company intends to initiate a phase II study on SYN-010 during the first half of 2015 for the treatment of constipation-predominant irritable bowel syndrome.
We note that 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 the company, there are no approved therapies for the protection of the microbiome from damaging effects of IV antibiotics.
Actelion (ALIOF) is developing cadazolid 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 Amgen Inc. (AMGN) and The Medicines Co. (MDCO). Both carry a Zacks Rank #1 (Strong Buy).
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