Protagonist Therapeutics today announced topline results from the Phase 2 IDEAL study evaluating PN-943 in patients with moderate-to-severe ulcerative colitis (UC).
“We are delighted with the strength of the results from the IDEAL study and look forward to working with the regulatory agencies as we prepare for a Phase 3 registrational program for PN-943 in moderate-to-severe ulcerative colitis,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. “Our oral, gut-restricted alpha-4-beta-7-integrin antagonist agent PN-943 has demonstrated clinical efficacy on par with the approved injectable antibody drug working through the same biological target. We believe the results of the IDEAL study may be paradigm shifting and of broad scientific relevance in understanding IBD pathogenesis and gut-restricted drug development via intervention of the integrin-MAdCAM pathway. Based on its convenience of oral administration and the favorable efficacy and safety results observed to date, we believe that PN-943 has the potential to become a first-in-class, foundational oral medicine for individuals living with moderate-to-severe ulcerative colitis.”
“With the IDEAL study, we have demonstrated clinical proof-of-concept and validation for potential treatment of ulcerative colitis via oral, gut-restricted blockade of the alpha-4-beta-7-integrin pathway,” said Scott Plevy, M.D., Executive Vice President and Therapeutic Head of Gastroenterology at Protagonist. “The study assessed two doses of PN-943, 150 mg BID and 450 mg BID, and demonstrated a very clear and consistent treatment effect at the lower 150 mg BID dose across key endpoints. The dose response demonstrated by this study is consistent with several other modalities in the integrin pathway. The findings in the lower-dose arm provide consistent evidence of clinical efficacy and safety, and clear direction on the dosing regimen for the Phase 3 registrational program.”
“The oral, gut-restricted agent PN-943 appears to exert similar effects at the twice daily 150 mg dose in comparison to the approved injectable alpha-4-beta-7-integrin antibody drug and its mechanism of action,” said Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, principal investigator for the IDEAL study and consultant to Protagonist. “There is a clear unmet need and strong clinical benefit for patients with an oral agent working through such a proven IBD specific mechanism, and the IDEAL study results provide good rationale for moving PN-943 forward in a Phase 3 registrational study.”