The first patient has been enrolled in Protalix BioTherapeutics' (NYSEMKT:PLX) Phase 2 clinical trial assessing OPRX-106 in ulcerative colitis (UC). Initial data should be available in the second half of next year.
The open-label two-arm study will enroll 20 subjects with mild-to-moderate UC. Participants will be randomized to receive a daily oral dose of either 2 mg or 8 mg of OPRX-106 for eight weeks. The primary endpoint is safety. Secondary endpoints include clinical response.
If successful, OPRX-106 will be the first oral enzyme treatment for UC. It is a plant-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain. It is based on the company's ProCellEx platform.