Synthetic Biologics cans phase 2 IBS trial deemed likely to fail

Synthetic Biologics and Cedars-Sinai Medical Center are pulling the plug on a phase 2b study in irritable bowel syndrome because it’s unlikely to hit its primary objective. Cedars-Sinai, the sponsor, will do a “comprehensive review” of the data and publish the findings.

The study tested two dose levels of SYN-010, a modified version of lovastatin lactone, against placebo in patients who had irritable bowel syndrome with constipation (IBS-C). The goal of the 12-week study was to boost the number of complete spontaneous bowel movements patients had on average per week.

An interim futility analysis deemed the study unlikely to meet this goal by the time it finished enrolling, the company said in a statement Friday.

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Synthetic Biologics had sought to provide a new option for patients who rely on prescription and over-the-counter laxatives to manage their symptoms but do not have a drug to address the root cause of IBS-C.

"We are grateful to the patients and Cedars-Sinai who supported this clinical trial. Although the results were disappointing for SYN-010, we remain committed to the development of new life changing medications for GI diseases," Synthetic Biologics CEO Steven Shallcross said in the statement.

"Looking forward, we remain focused on working with our clinical development partners to advance the planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) patients, and to advance the clinical development program for SYN-020 intestinal alkaline phosphatase (IAP) in multiple potential indications,” Shallcross added.

The company is developing ribaxamase to ward off Clostridium difficile infections, the overgrowth of disease-causing organisms and antibiotic resistance in patients taking certain antibiotics. It works by degrading commonly used intravenous beta-lactam antibiotics in the gut.