FDA News

SYN-010 for IBS-C to enter phase 3 development following FDA meeting

Synthetic Biologics today announced it has completed an End of Phase 2 meeting with the FDA for SYN-010, its microbiome-based anti-methane drug for the treatment of constipation-predominant irritable bowel syndrome.

SYN-010 (Synthetic Biologics) is a modified-release formulation of lovastatin lactone designed to treat a major underlying cause of constipation-predominant IBS (IBS-C) by reducing methane produced by Methanobrevibacter smithii gut microbes while minimizing microbiome disruption, according to a press release. Higher intestinal methane production has been linked to pain, bloating and constipation in IBS-C patients. The drug is intended to target the intestinal lumen and avoid systemic absorption of the cholesterol-lowering metabolite form of lovastatin.

After reviewing data from two phase 2 clinical trials, which showed the drug significantly reduced methane production and IBS symptoms, the company collaborated with the FDA to determine the best pathway to advance the drug into phase 3 trials, and was ultimately encouraged to execute a phase 2b/3 adaptive trial design. This first pivotal clinical trial will address further dose exploration and sensitivity analysis of breath methane levels for trial participation, according to the press release.

“Outcomes from our two phase 2 clinical trials continue to emphasize the need for the development of a treatment that targets one of the underlying causes of IBS-C and allows us to take the next step in bringing a product to market with the potential to address this largely unmet medical need,” Jeffrey Riley, CEO of Synthetic Biologics, said in the press release. “We were very pleased with the collaborative nature of our meeting with FDA as well as the Agency’s recommendations on the path forward towards a pivotal trial for SYN-010.”

Disclosures: Riley is employed by Synthetic Biologics.

Synthetic Biologics today announced it has completed an End of Phase 2 meeting with the FDA for SYN-010, its microbiome-based anti-methane drug for the treatment of constipation-predominant irritable bowel syndrome.

SYN-010 (Synthetic Biologics) is a modified-release formulation of lovastatin lactone designed to treat a major underlying cause of constipation-predominant IBS (IBS-C) by reducing methane produced by Methanobrevibacter smithii gut microbes while minimizing microbiome disruption, according to a press release. Higher intestinal methane production has been linked to pain, bloating and constipation in IBS-C patients. The drug is intended to target the intestinal lumen and avoid systemic absorption of the cholesterol-lowering metabolite form of lovastatin.

After reviewing data from two phase 2 clinical trials, which showed the drug significantly reduced methane production and IBS symptoms, the company collaborated with the FDA to determine the best pathway to advance the drug into phase 3 trials, and was ultimately encouraged to execute a phase 2b/3 adaptive trial design. This first pivotal clinical trial will address further dose exploration and sensitivity analysis of breath methane levels for trial participation, according to the press release.

“Outcomes from our two phase 2 clinical trials continue to emphasize the need for the development of a treatment that targets one of the underlying causes of IBS-C and allows us to take the next step in bringing a product to market with the potential to address this largely unmet medical need,” Jeffrey Riley, CEO of Synthetic Biologics, said in the press release. “We were very pleased with the collaborative nature of our meeting with FDA as well as the Agency’s recommendations on the path forward towards a pivotal trial for SYN-010.”

Disclosures: Riley is employed by Synthetic Biologics.