Ordesekimab

Teva Pharmaceutical's dreams of a first-in-class autoimmune blockbuster are being kept alive after the Israeli outfit’s anti-interleukin-15 antibody scored a midstage win in celiac disease. In a phase 2a trial of 50 adults with celiac disease, patients received a dose of either TEV ‘408 or placebo and then, two weeks later, began eating gluten every day for six weeks. TEV ‘408 reduced the amount of intestinal damage caused by gluten significantly more than placebo, Teva reported today, hitting the trial’s primary endpoint. Teva has observed no safety signals associated with the antibody, according to the release. “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source,” Eric Hughes, M.D., Ph.D., Teva’s chief medical officer and head of global R&D, said in the release. “They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.” More dose-ranging and analysis of the phase 2 data are needed before a phase 3 follow-up can proceed, a Teva spokesperson told Fierce. “The celiac timeline remains subject to clinical results and regulatory alignment,” the spokesperson said. “Celiac remains a priority and will progress as quickly as possible.” Teva is also testing the antibody in the skin disease vitiligo, with plans to launch a phase 2b trial in the indication later this year. Royalty Pharma agreed earlier this year to help fund the trial and a potential phase 3 follow-up with up to $500 million in exchange for a share of the vitiligo sales haul, should TEV ‘408 be approved. There are currently no approved drugs that inhibit IL-15, a proinflammatory protein. Other similar antibodies are in the works from Novartis (picked up from Calypso Biotech in 2024) and argenx (from this summer’s $2.2 billion buy of Forte Biosciences ). Novartis’ prospect targets IL-15 alone, like TEV ‘408, while argenx’s option also hits interleukin-2 by targeting CD122. Comparing these different antibodies is currently unwise, Umer Raffat, a biotech industry analyst with Evercore ISI, cautioned in a note to investors today. That said, Teva’s data is good but unsurprising, he wrote, and the company “identified a potentially optimal dose.” The expected nature of the result—given other anti-IL-15 antibodies have also shown activity in celiac disease—may explain the lack of movement in Teva’s stock this morning. “Teva’s R&D turnaround keeps getting better and continues to bode well for continued stock upside,” Raffat added. Teva considers TEV ‘408 a potential “pipeline in a product,” but has not yet revealed plans beyond celiac disease and vitiligo. “There’s broad relevance across high-prevalence autoimmune diseases in gastroenterology, dermatology and rheumatology,” the Teva spokesperson told Fierce. The pharma has been operating with a growth mindset as of late, recently agreeing to scoop up bankrupt BioXcel Therapeutics’ assets for $57.5 million upfront and bringing in $400 million from Blackstone Life Sciences to power development of a Sanofi-partnered anti-TL1A antibody for inflammatory bowel disease.