Synthetic Biologics, Inc. SYN announced positive top-line results from the first phase IIa study on SYN-004 for protecting gut microbiome from the unintended effects of certain commonly used intravenous beta-lactam antibiotics for the prevention Clostridium difficile (C. difficile) infection and antibiotic-associated diarrhea.
The randomized, multi-center, open-label phase IIa study evaluated the ability of two dose strengths of SYN-004 to degrade residual IV ceftriaxone in the gastro-intestinal (GI) tract in 10 ileostomized participants, without affecting the concentrations of IV ceftriaxone in the bloodstream. Top-line data from the study revealed that both dosage strengths of SYN-004 successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream. Additionally, both dosage strengths of SYN-004 were well tolerated.
Meanwhile, Synthetic Biologics is conducting a second phase IIa study on SYN-004 to evaluate the GI antibiotic degrading effects and safety of the candidate in the presence of proton pump inhibitor, esomeprazole, in participants with functioning ileostomies. Top-line data from the second phase IIa study is expected to mature in the first half of 2016.
Apart from that, the company is conducting a phase IIb proof-of-concept study on SYN-004 to evaluate the effectiveness of SYN-004 to prevent C. difficile infection and C. difficile-associated diarrhea, as well as antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection, who are receiving IV ceftriaxone.
We are pleased with Synthetic Biologics’ progress on its pipeline. As per data provided by IMS Health, in 2012, around 14 million patients in the U.S. received approximately 118 million doses of IV beta-lactam antibiotics that could be inactivated in the GI tract by SYN-004, thus representing bright prospects for the candidate.
Synthetic Biologics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Actelion Ltd. ALIOF and Baxalta Incorporated BXLT. While Anika and Baxalta sport Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).
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