Novartis has ended work on ianalumab in a painful skin condition after the monoclonal antibody failed to meet “predefined efficacy thresholds” in a phase 2 study.
The Swiss pharma had been evaluating ianalumab, a dual-mechanism, B-cell-depleting antibody that targets the protein BAFF-R, in a midstage study of hidradenitis suppurativa—a skin disease that causes painful lumps to form in areas where the skin rubs together. The company already markets Cosentyx for the skin condition.
In its second-quarter earnings results, Novartis revealed that it will now stop development of ianalumab in this indication after the phase 2 trial “did not meet our target criteria despite demonstrating efficacy versus placebo.”
“No new safety signals were observed and all other studies for ianalumab in B-cell driven diseases continue as planned,” the drugmaker added.
Novartis is still, however, lining up the drug for an approval application next year in Sjögren’s disease, an immune disorder that causes dry eyes and a dry mouth. At the start of the year, the company abandoned attempts to develop its anti-CD40 antibody iscalimab for the same disorder.
At the time, Novartis’ chief medical officer and head of development Shreeram Aradhye, M.D., pointed out to Fierce Biotech that ianalumab had already “shown meaningful differences in patients with this very difficult to treat disease” in a phase 2 trial.
A pair of phase 3 trials for ianalumab in Sjögren’s disease are due to read out in the second half of this year, along with a late-stage study in second-line immune thrombocytopenia.
Despite not pursuing ianalumab in hidradenitis suppurativa, Novartis still has another pipeline option for the skin condition in the form of remibrutinib. The BTK inhibitor was shown to reduce disease activity in a phase 2b trial last year and is currently being studied in pair of phase 3 trials due to read out in 2028.