Novartis is stopping the development of ianalumab in hidradenitis suppurativa (HS) after a Phase IIb proof-of-concept trial failed to meet its primary endpoint.
The study (NCT03827798) had enrolled 248 patients with HS and was evaluating the change in simplified Hidradenitis Suppurativa Clinical Response (sHiSCR) after 16 weeks.
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The termination of the therapy in HS was announced in Novartis’ Q2 results, with the company stating: “Novartis will not advance investigation of ianalumab in HS following a Phase II proof-of-concept study which did not meet our target criteria despite demonstrating efficacy vs placebo. No new safety signals were observed, and all other studies for ianalumab in B-cell driven diseases continue as planned.”
The indications Novartis will continue the development of ianalumab for include lupus nephritis, Sjögren syndrome, and autoimmune hepatitis.
Ianalumab is a monoclonal antibody directed against the BAFF (B cell-activating factor belonging to the TNF family) receptor. It acts by preventing the activation of B cells to avoid overproduction. By reducing the number and activity of B cells, ianalumab can help to dampen the harmful immune responses that drive autoimmune diseases.
If approved, GlobalData predicts ianalumab to reach sales of $638m in 2031.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
Four other pipeline drugs in Phase IIb study
The Phase IIb trial also evaluated the efficacy of four other drugs in Novartis’ pipeline, namely iscalimab, remibrutinib, LYS-006 and MAS-825.
Data from the remibrutinib was presented at the American Academy of Dermatology (AAD) meeting in March 2024, with the drug having met its primary endpoint. As a result, Novartis is now running a Phase III trial of the therapy in HS (NCT06799000).
Novartis has already secured a drug in the HS treatment space, after Cosentyx (secukinumab) gained approval from the US Food and Drug Administration (FDA) in October 2023.
UCB’s Bimzelx (bimekizumab) is the most recent biologic in HS, having been approved by the FDA in November 2024.
AbbVie’s flagship Humira (adalimumab) is also approved in HS and was the first biologic to be approved in the indication in 2015.
