DOR BioPharma Collaborates with Numoda in Phase III Clinical Trial

DOR BioPharma is collaborating with Numoda, a clinical trials information services company, in its upcoming confirmatory Phase III clinical trial of orBec in the treatment of gastrointestinal graft-versus-host disease (GI GVHD).

The drug (oral beclomethasone dipropionate) is a corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation, DOR said.

Numoda will provide operational, financial and logistical services for the trial. DOR recently received a not-approvable letter from the FDA for orBec requesting additional data to confirm the drug’s safety and efficacy.