Synthetic Biologics Inc (NYSEMKT:SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, announced that experimental results supporting the proposed therapeutic mode-of-action of SYN-010 in irritable bowel syndrome with constipation (IBS-C) were presented today in a poster at the American College of Gastroenterology (ACG) Annual Meeting in Honolulu, HI. The research was sponsored by Synthetic Biologics and performed at Cedars-Sinai under the direction of Mark Pimentel, M.D., FRCP©, Director of Cedars-Sinai Medical Center’s (CSMC) GI Motility Program and Laboratory, and Chairman of Synthetic Biologics’ IBS-C Clinical Advisory Board.
“The presentation at the ACG Annual Meeting highlighted the therapeutic potential of SYN-010 for IBS-C,” stated Jeffrey Riley, Chief Executive Officer for Synthetic Biologics. “As we continue to move our IBS-C program through two ongoing Phase 2 clinical trials, this research, along with SYN-010’s novel modified-release formulation of the widely prescribed lovastatin lactone, provides a strong body of support for SYN-010’s efficacy in reducing methane levels in the gut. We continue to expect topline results from the first Phase 2 clinical trial of SYN-010 during the fourth quarter of 2015, and topline results from the second Phase 2 clinical trial during the first half of 2016.”
Synthetic Biologics’ proprietary SYN-010 is a modified-release formulation of the lactone form of lovastatin that is intended to reduce methane production by certain microorganisms (M. smithii) in the gut while minimizing disruption to the microbiome. Methane produced by M. smithii is perceived as the underlying cause of pain, bloating, and constipation associated with IBS-C, and published reports have associated higher intestinal methane production with increased constipation severity in IBS-C patients. SYN-010 is intended to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the major cause of IBS-C, not just the symptoms.
The CSMC poster, entitled “Lovastatin Lactone Inhibits Methane Production in Human Stool Homogenates,” included data from studies comparing the effects of different statins and statin forms (lactone vs. beta-hydroxyacid) on methane production by stool homogenates from five female donors with high levels of breath methane. Dr. Pimentel concluded that, of the various statins examined, lovastatin lactone was the only effective inhibitor of methane production in the stool homogenates, significantly inhibiting methane levels by -65% compared to the control stool.
“This lovastatin data suggests that SYN-010 has therapeutic potential to diminish the production of methane in the gut, thereby treating the cause of IBS-C, not just the symptoms,” said Dr. Mark Pimentel.
Synthetic Biologics anticipates a 505(b)(2) regulatory pathway for SYN-010 which is designed to reduce the impact of methane producing organisms on IBS-C. An extensive portfolio of granted use patents and pending applications for SYN-010 has been licensed by CSMC to Synthetic Biomics, Inc., a subsidiary of Synthetic Biologics, Inc. CSMC also holds a minority equity interest in Synthetic Biomics. (Original Source)
Shares of Synthetic Biologics opened today at $2.47 and are currently trading down at $2.43. SYN has a 1-year high of $4.32 and a 1-year low of $1.36. The stock’s 50-day moving average is $2.55 and its 200-day moving average is $2.54.
On the ratings front, Synthetic Biologics has been the subject of a number of recent research reports. In a report issued on October 12, RBC analyst Adnan Butt initiated coverage with a Buy rating on SYN and a price target of $8, which implies an upside of 223.9% from current levels. Separately, on October 8, BTIG’s Tim Chiang reiterated a Buy rating on the stock and has a price target of $5.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Adnan Butt and Tim Chiang have a total average return of -6.0% and 15.5% respectively. Butt has a success rate of 47.0% and is ranked #3500 out of 3793 analysts, while Chiang has a success rate of 69.4% and is ranked #421.
Synthetic Biologics Inc is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases.