FDA News

FDA grants orphan designation to microbiome drug for pediatric UC

Seres Therapeutics announced the FDA has given its microbiome drug candidate SER-287 Orphan Drug Designation for the treatment of pediatric ulcerative colitis.

SER-287 is “a biologically sourced, oral formulation containing a consortium of live bacterial spores that is being developed for ulcerative colitis and other forms of inflammatory bowel disease,” according to a press release. It is thought to work by altering the dysbiotic microbiome, to improve colonic barrier integrity and reduce inflammation without suppressing the immune system.

Orphan Drug Designation, which incentivizes drug development for rare diseases or conditions, is based on phase 1b clinical data that provides “a medically plausible basis” for the use of this novel treatment in UC.

This was a placebo-controlled study of SER-287 in patients with mild-to-moderate UC for whom current treatments had failed. The study drug improved clinical remission rates and endoscopic scores in a dose-dependent fashion, and showed “a very favorable safety profile,” thus showing potential as an effective and safer alternative to current therapies, according to the press release.

As Healio Gastroenterology and Liver Disease previously reported, the company shared some details from this study in October, and it expects microbiome data from this study will be available early next year.

“We are pleased to receive FDA Orphan Drug Designation for SER-287 and we look forward to advancing the program into further development for ulcerative colitis,” Roger J. Pomerantz, MD, president, CEO and chairman of Seres, said in the press release. “Based on the highly encouraging phase 1b clinical results and favorable safety profile, we intend to evaluate SER-287 in a pediatric UC population as part of our overall development plan. Safety is of particular importance to the pediatric population, and given the positive safety profile observed in our clinical trial to date, we believe our microbiome approach may be well suited to address this group.”

 

Disclosures: Pomerantz is employed by Seres.

Seres Therapeutics announced the FDA has given its microbiome drug candidate SER-287 Orphan Drug Designation for the treatment of pediatric ulcerative colitis.

SER-287 is “a biologically sourced, oral formulation containing a consortium of live bacterial spores that is being developed for ulcerative colitis and other forms of inflammatory bowel disease,” according to a press release. It is thought to work by altering the dysbiotic microbiome, to improve colonic barrier integrity and reduce inflammation without suppressing the immune system.

Orphan Drug Designation, which incentivizes drug development for rare diseases or conditions, is based on phase 1b clinical data that provides “a medically plausible basis” for the use of this novel treatment in UC.

This was a placebo-controlled study of SER-287 in patients with mild-to-moderate UC for whom current treatments had failed. The study drug improved clinical remission rates and endoscopic scores in a dose-dependent fashion, and showed “a very favorable safety profile,” thus showing potential as an effective and safer alternative to current therapies, according to the press release.

As Healio Gastroenterology and Liver Disease previously reported, the company shared some details from this study in October, and it expects microbiome data from this study will be available early next year.

“We are pleased to receive FDA Orphan Drug Designation for SER-287 and we look forward to advancing the program into further development for ulcerative colitis,” Roger J. Pomerantz, MD, president, CEO and chairman of Seres, said in the press release. “Based on the highly encouraging phase 1b clinical results and favorable safety profile, we intend to evaluate SER-287 in a pediatric UC population as part of our overall development plan. Safety is of particular importance to the pediatric population, and given the positive safety profile observed in our clinical trial to date, we believe our microbiome approach may be well suited to address this group.”

 

Disclosures: Pomerantz is employed by Seres.

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