OPRX-106 for mild-to-moderate UC performs well in phase IIa trial
Oral administration of the nonabsorbable OPRX-106 shows potential in the treatment of mild-to-moderate ulcerative colitis (UC), delivering favourable anti-inflammatory immune modulation without concurrent immune suppression, according to the results of a phase IIa trial.
Twenty-five patients with active mild-to-moderate UC were randomized to receive 2 or 8 mg of OPRX-106 administered orally once daily for 8 weeks. Researchers assessed safety and efficacy, with outcomes including clinical response or clinical remission, based on the Mayo score. They also monitored histopathological improvement in Geboes score, calprotectin level and hs-CRP, and exploratory immune parameters by means of fluorescence-activated cell sorting and cytokine levels.
Eight-week treatment with OPRX-106 was generally safe and well tolerated without absorption into the circulation.
Among the 18 patients who completed the trial, 67 percent showed clinical response and 28 percent achieved clinical remission. Furthermore, calprotectin levels decreased while Geboes score improved in the majority of the treated patients.
The beneficial clinical effect observed with OPRX-106 correlated with an increase in a CD4+CD25+FoxP3 subset of suppressor lymphocytes and a decline in interleukin 6 and interferon gamma serum levels.
OPRX-106 is an orally administered BY2 plant cell-expressing recombinant TNF fusion protein, and the present data confirm its safety and efficacy in patients with UC.