Novel Orally Administered Recombinant Anti-TNF Alpha Fusion Protein for the Treatment of Ulcerative Colitis: Results From a Phase 2a Clinical Trial.

"Y.I. is a consultant to Protalix Biotherapeutics. E.A., Y.S., S.A., R.C., and B.-c.A.-C. are employees of Protalix Biotherapeutics. The remaining authors declare that they have nothing to disclose."

"Supported by Protalix Biotherapeutics."

"The clinical trial was a phase 2a, open-label, randomized study, which examined the safety, PK, and exploratory efficacy of OPRX-106 in patients with UC. The subjects were enrolled in 8 centers in Israel, Serbia, and Bulgaria. OPRX-106 consisted of lyophilized, genetically modified plant cells expressing the human tumor necrosis factor receptor-Fc fusion protein (TNFR-Fc), a dimeric soluble fusion protein of the TNF-2 receptor protein and the Fc fragment of IgG1. The product was manufactured by the sponsor Protalix Ltd. (Carmiel, Israel). The trial was registered at ClinicalTrials.gov, NCT02768974."