Weeks after earning CEO's stamp of approval, a Novartis skin drug loses head-to-head battle with standard of care
With a jam-packed pipeline to parse, Novartis chief Vas Narasimhan has helped investors out in the past by highlighting a few key programs his team thinks could be easy winners. One of those drugs has now hit the skids in two late-stage tests, losing some of its luster as a potential centerpiece medicine moving ahead.
Novartis’ ligelizumab, a “high-affinity” anti-immunoglobulin E antibody failed to beat out standard-of-care Xolair — its own partnered drug with Genentech — in two Phase III studies in patients with the skin disease chronic spontaneous urticaria, the company said Monday.
In the Phase III PEARL-1 and PEARL-2 studies, ligelizumab bested a placebo control after 12 weeks of dosing but couldn’t match up to Xolair in reducing patients’ symptoms. The drugmaker will dive into these data as it reconsiders its path forward for the drug in this disease, Novartis said.
Novartis R&D chief John Tsai added: “We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU. We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”
The setback comes just weeks after Narasimhan touted the candidate as a likely winner. Novartis is still planning to pursue ligelizumab’s case in inducible urticaria and food allergy, where it still believes the candidate has a chance of success. This setback against Xolair is particularly vexing given that ligelizumab showed head-to-head benefit over Xolair in reducing hives in a Phase IIb dose-finding study.
As ligelizumab’s chances in this disease falter, Novartis has also trialed remibrutinib, its next-gen BTK inhibitor, in multiple Phase III trials in CSU, hoping for a better result.