AbbVie is ending development of an IL-1 asset as a monotherapy in ulcerative colitis (UC) after a phase 2 study revealed insufficient efficacy results.
The drug in question is lutikizumab, a dual-variable domain immunoglobulin targeting IL-1, tested as a monotherapy in a pair of phase 2 atopic dermatitis trials, the midstage UC study and a phase 3 trial for hidradenitis suppurativa.
“An interim analysis was recently completed on our monotherapy trial evaluating lutikizumab in ulcerative colitis,” Roopal Thakkar, M.D., AbbVie’s chief scientific officer and executive vice president of R&D, said during the pharma’s Q2 earnings call.
“Lutikizumab showed numerically higher efficacy for the primary endpoint of endoscopic improvement compared to Humira, which was the control arm,” Thakkar continued. “However, the results were not sufficiently differentiated for us to pursue it as a monotherapy in this patient population.”
An AbbVie spokesperson referred to Thakkar’s comments when asked by Fierce if the study had failed to achieve statistical significance.
While not sufficiently effective as a monotherapy in UC, AbbVie believes lutikizumab could “drive incremental efficacy as a combination therapy in Crohn's disease,” R&D head Thakkar said on the call. Crohn’s and UC are both types of inflammatory bowel disease, but Crohn’s can impact any part of the digestive tract while UC causes inflammation in just the large intestine.
The investigational asset is currently being evaluated in a phase 2 trial by itself and in combination with AbbVie’s Skyrizi (risankizumab) for Crohn’s, with the combo results expected to read out next year, Thakkar said. The trial is actively recruiting and aims to enroll 500 patients, according to ClinicalTrials.gov.
“Lutikizumab has the potential to drive efficacy across other autoimmune diseases,” Thakkar continued. “It has demonstrated strong efficacy in hidradenitis suppurativa, where phase 3 is ongoing, with data expected in 2027.”
Additional studies are ongoing to test the asset as a monotherapy or combination approach for psoriatic arthritis, atopic dermatitis and rheumatoid arthritis, Thakkar added.
AbbVie’s pipeline changes are relatively tame compared to other Big Pharma’s this quarter, with no whole asset terminations reported on the call.
The Illinois-based pharma’s total revenue for the quarter came in above estimates at $15.4 billion, driven in part by the strength of Skyrizi sales, which have grown 62% year-over-year.
The company’s acquired in-process research and development (IPR&D) and milestone expenses accounted for 5.3% of net revenues.
The pharma inked some hefty deals in the quarter: a $2.1 billion buyout of Capstan Therapeutics for its in vivo CAR-Ts; a $335 million cash payment to secure options to ADARx Pharmaceuticals’ next-gen small interfering RNA candidates; and a $700 million upfront deal with Ichnos Glenmark Innovation for a potential rival to Johnson & Johnson’s Tecvayli for melanoma.
AbbVie has also reportedly added Gilgamesh Pharmaceuticals to its shopping list. The Big Pharma teamed up with Fierce 15 2024 winner Gilgamesh last year and is now in talks to buy the psychiatric disorder-focused biotech for about $1 billion, according to Bloomberg.