Synthetic Biologics Inc (NYSEMKT:SYN) announced this morning that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application which covers the use of the active agent of SYN-010, the Company’s proprietary, modified-release formulation of lovastatin lactone, for the treatment of constipation. Upon issuance, this patent will strengthen the intellectual property estate covering the use of SYN-010 for the treatment of IBS-C until at least 2034, affording the Company an extended term for commercialization.
U.S. Patent Application No. 14/776,465, which is owned by Cedars-Sinai Medical Center (CSMC) and exclusively licensed to Synthetic Biologics, is based on innovative research led by Mark Pimentel, M.D., FRCP(C), Program Director of CSMC’s Medically Associated Science and Technology (MAST) Program and Chairman of Synthetic Biologics’ IBS-C Clinical Advisory Board, which correlates methane production in the gut by certain microorganisms (M. smithii) with symptoms commonly associated with IBS-C.
The allowance of this new patent expands the SYN-010 intellectual property portfolio to approximately 55 issued U.S. and foreign patents. In addition, there are approximately 25 U.S. and foreign patents pending, which upon issuance should further strengthen the intellectual property position surrounding SYN-010.
“Once issued, this patent will extend the protection around the use of SYN-010 to treat IBS-C by an additional eleven years and significantly strengthens the opportunity to build long-term value for our shareholders,” said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “We remain focused on the continued clinical advancement of SYN-010 and are encouraged that we are making excellent progress in providing patients with a novel, potentially best-in-class therapy that directly targets an underlying cause of the symptoms associated with IBS-C.”
Previously announced results from Phase 2 clinical trials conducted by Synthetic Biologics demonstrated SYN-010 significantly reduced abdominal pain and bloating while also improving stool frequency and quality of life scores without severe adverse events in IBS-C patients. Following collaborative discussions with the U.S. Food and Drug Administration (FDA), the Company announced the approval of a Phase 2b/3 adaptive design pivotal trial intended to further evaluate the efficacy and safety of SYN-010.
Shares of Synthetic Biologics are up nearly 3% to $0.65 in pre-market trading Tuesday. SYN has a 1-year high of $1.94 and a 1-year low of $0.41. The stock’s 50-day moving average is $0.60 and its 200-day moving average is $0.70.
On the ratings front, William Blair analyst Y Katherine Xu reiterated a Buy rating on SYN, in a report issued on March 3. According to TipRanks.com, Xu has a yearly average return of 14.2%, a 49% success rate, and is ranked #662 out of 4596 analysts.
Synthetic Biologics, Inc. is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. Its product portfolio includes SYN-010 and SYN-004. The SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation. The SYN-004, which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance.