LNA-043

Novartis had already given up developing iscalimab for liver transplant patients in 2022.\n Novartis has finally given up on iscalimab after deciding that the anti-CD40 antibody is not worth pursuing in Sjögren’s syndrome.On a fourth-quarter earnings call with the media this morning, Novartis’ chief medical officer and head of development Shreeram Aradhye, M.D., told Fierce Biotech that the Swiss pharma had stopped work on iscalimab “based on our assessment that the benefit/risk [profile] for what we have seen was not compatible with a competitive profile.”Iscalimab had previously shown promise in treating Sjögren’s, an immune disorder that causes dry eyes and a dry mouth. Phase 2 results showed “initial clinical benefit over placebo in two distinct populations of patients,” according to a write-up in The Lancet journal last year.Novartis had already given up developing iscalimab for liver transplant patients in 2022 after a phase 2 trial found the drug had a “less favorable risk-benefit profile” than tacrolimus, which Astellas Pharma sells as Prograf. At the time, Novartis had still been eyeing up a potential approval for iscalimab in Sjögren’s in 2026 if the data had gone its way. Despite now dropping iscalimab entirely, Aradhye said Sjögren’s “remains an area of interest for us, because it is an underserved disease with a lot of patients who need alternative options.”“Ianalumab, which is our dual mechanism, B cell depleting antibody, is actually the one that will read out in this year on our trial in Sjögren’s,” he said in response to a question from Fierce. “It is the one trial where in phase 2 we have shown meaningful differences in patients with this very difficult to treat disease.”Last year, Sanofi crossed off Sjögren’s from the list of targeted indications for its CD40L monoclonal antibody frexalimab after seeing phase 2 efficacy data.Novartis removed one other drug from its pipeline this morning in the form of LNA043. The ANGPTL3 agonist had been in development for osteoarthritis, but Novartis said the program had been discontinued following a phase 2 readout.