Synthetic Biologics Inc (NYSEMKT:SYN) confirmed plans to initiate a Phase 2b/3 adaptive pivotal trial for SYN-010, the Company’s modified-release reformulation of lovastatin lactone designed to reduce methane production by certain microorganisms (M. smithii) in the gut to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company anticipates initiating this trial by the end of the first quarter of 2017.
In accordance with collaborative discussions with the FDA, key components of the SYN-010 Phase 2b/3 adaptive pivotal trial will include:
- A 12-week, multi-center, double-blind, placebo-controlled, adaptive design clinical trial
- A study population of approximately 840 adult subjects diagnosed with IBS-C
- Evaluation of efficacy and safety of two dose strengths of SYN-010 (21 mg and 42 mg) compared to placebo
- Conducted in approximately 150 clinical sites in North America
- Study subjects will be randomized in a 1:1:1 ratio, receiving either 21 mg of SYN-010, 42 mg of SYN-010, or placebo
- Enrollment is open to all IBS-C patients; breath-methane will be measured at baseline to ensure a comparable ratio of high-to-low breath methane IBS-C patients in each treatment arm
- An interim futility analysis may be conducted when approximately 50% of patients in each dosing arm have completed treatment
“We are pleased with the direction that we received from the FDA on the clinical trial design for SYN-010,” said Jeffrey Riley, President and Chief Executive Officer. “With a clear path forward for SYN-010’s clinical development, we are one step closer to achieving our goal of providing patients with a novel, potentially best-in-class therapy that directly targets a cause of IBS-C, thereby alleviating symptoms and preventing their recurrence.”
Consistent with FDA written guidance, the primary objective for this study is to determine the efficacy of SYN-010, measured as an improvement from baseline in the percentage of overall weekly responders during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses compared to placebo. Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, bowel movement frequency and stool consistency. Exploratory outcomes include Adequate Relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.
Synthetic Biologics also recently announced the achievement of the primary endpoint from its Phase 2b proof-of-concept clinical trial of SYN-004 (ribaxamase). Preliminary analysis of the data demonstrated a statistically significant reduction in both C. difficile infection (CDI) (p-value=0.045; relative risk reduction of 71.4%) and new colonization by vancomycin-resistant enterococci (VRE) (p-value=0.0002) for patients receiving ribaxamase compared to placebo.
Shares of Synthetic Biologics are up nearly 7% to $0.88 in after-hours trading. SYN has a 1-year high of $2.74 and a 1-year low of $0.73. The stock’s 50-day moving average is $0.84 and its 200-day moving average is $1.40.
On the ratings front, FBR analyst Edward White reiterated a Buy rating on SYN, with a price target of $6.00, in a report issued on January 11. The current price target implies an upside of 641% from current levels. According to TipRanks.com, White has a yearly average loss of 15.2%, a 18% success rate, and is ranked #4271 out of 4350 analysts.
Synthetic Biologics, Inc. is a clinical stage company, which develops therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. Its products portfolio includes SYN-004 and SYN-010. 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 and antibiotic-associated diarrhea. 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.