Novartis Halts Ianalumab Development for Hidradenitis Suppurativa, Continues Pursuit in Other Indications

Novartis, the Swiss pharmaceutical giant, has announced the discontinuation of its ianalumab program for hidradenitis suppurativa following disappointing results in a phase 2 clinical trial. Despite this setback, the company remains committed to developing the drug for other B-cell-driven diseases, with promising data in Sjögren's syndrome positioning it for a potential approval application next year.

Ianalumab Falls Short in Dermatology Study

Novartis revealed in its second-quarter earnings report that ianalumab, a dual mechanism B cell-depleting antibody targeting the BAFF-R protein, failed to meet "predefined efficacy thresholds" in a phase 2 study for hidradenitis suppurativa. This painful skin condition causes lumps to form in areas where skin rubs together. Despite demonstrating efficacy versus placebo, the results did not meet the company's target criteria, leading to the termination of development in this indication.

The company emphasized that no new safety signals were observed during the trial, maintaining the drug's safety profile. Novartis already markets Cosentyx for hidradenitis suppurativa, which may have influenced the decision to halt ianalumab's development in this area.

Continued Development in Other Indications

While ianalumab's journey in dermatology has ended, Novartis continues to pursue its development in other B-cell-driven diseases. The company is particularly optimistic about the drug's potential in Sjögren's syndrome, an immune disorder characterized by dry eyes and mouth.

Two phase 3 trials for ianalumab in Sjögren's syndrome are expected to yield results in the second half of this year. Additionally, a late-stage study in second-line immune thrombocytopenia is ongoing. These trials will be crucial in determining the future of ianalumab and its potential to address unmet medical needs in these indications.

Shreeram Aradhye, M.D., Novartis' chief medical officer and head of development, previously highlighted that ianalumab had "shown meaningful differences in patients with this very difficult to treat disease" in a phase 2 trial for Sjögren's syndrome. This encouraging data supports the company's decision to pursue an approval application for ianalumab in this indication next year.

Alternative Pipeline Options and Future Outlook

Despite the setback in hidradenitis suppurativa, Novartis maintains a strong pipeline for addressing this skin condition. The company is currently developing remibrutinib, a BTK inhibitor, which has shown promise in reducing disease activity in a phase 2b trial last year. Two phase 3 trials for remibrutinib in hidradenitis suppurativa are underway, with results expected in 2028.

As Novartis refocuses its efforts on ianalumab's potential in Sjögren's syndrome and other B-cell-driven diseases, the pharmaceutical industry will be closely watching the upcoming phase 3 trial results. These data will not only shape the future of ianalumab but also provide valuable insights into the treatment landscape for autoimmune and inflammatory conditions.