An Israeli biotech looking to make a pill that would replace anti-TNF injectables — a multibillion dollar market — today reported good news from its small Phase II study in ulcerative colitis.
The company, called Protalix, says its therapy met the key efficacy endpoints of the trial. The drug is a recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain. Protalix says the therapy, called OPRX-106, is biologically active in the gut without triggering the formation of anti-drug antibodies — a key factor in the failure of anti-TNF treatments thus far.
“OPRX-106 has the potential to address the partial loss of response seen in anti-TNF alpha treatment, which is driven by the high presence of neutralizing antibodies,” Professor Yaron Ilan, a gastroenterology expert at The Hadassah Hebrew University Medical Center, said in a statement. “In addition, by being delivered orally, OPRX-106 could potentially avoid certain side effects, such as malignancies and opportunistic infections, which currently appear in the black box warning of the prescribing information for commercially-available anti-TNF alpha biologics.”
The company’s trial, however, was quite small, testing only 24 patients. Of those participants, only 18 completed the study. The key efficacy endpoints were met, with 67% of patients experiencing a clinical response and 28% of patients achieving clinical remission.
“We are very excited by these results,” Moshe Manor, Protalix’s president and CEO said in a statement. “They demonstrate efficacy and a lack of immunogenicity together with a favorable safety profile, which could potentially overcome one of the most challenging drawbacks of current ulcerative colitis therapies administered via injection and infusion.”
The company intends to release full results at a medical conference later in the year.
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