Pediatric Ulcerative Colitis Tx Granted Orphan Drug Status
A microbiome therapeutic candidate, SER-287 (Seres Therapeutics), for the treatment of Ulcerative Colitis (UC) in pediatric patients has been granted Orphan Drug Designation by the Food and Drug Administration (FDA).
The designation is based on a review of Phase 1b clinical data which showed potential for SER-287 as a novel treatment modality for patients with UC. The Phase 1b trial demonstrated promising results in patients with mild-to-moderate UC with data expected to be shared in early 2018.
SER-287 is an oral formulation that contains a consortium of live bacterial spores. It is thought that the treatment acts through a novel mechanism of action by modulating the dysbiotic microbiome, thereby reducing inflammation without immunosuppression.
“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,” said Roger J. Pomerantz, MD, CEO of Seres.
For more information visit Serestherapeutics.com.