Key Takeaways
- Shares of Novartis climbed approximately 5% following positive outcomes from two Phase 3 clinical studies of remibrutinib for multiple sclerosis
- The experimental oral treatment outperformed Sanofi’s teriflunomide (marketed as Aubagio) in decreasing relapse frequency among relapsing MS patients
- Remibrutinib demonstrated significant benefits in delaying disability progression without raising liver safety flags
- The pharmaceutical giant suspended eight clinical studies of rap-cel, an investigational cell therapy, following three patient fatalities from severe immune complications
- Oncology studies remained unaffected by the rap-cel suspension; the company intends to file for worldwide regulatory clearance for remibrutinib
Shares of Novartis experienced a substantial uptick of nearly 5% during early Tuesday sessions following the announcement of encouraging Phase 3 trial data for remibrutinib, the company’s investigational oral treatment for multiple sclerosis.
Two pivotal studies, designated REMODEL-1 and REMODEL-2, evaluated remibrutinib’s performance against teriflunomide, a currently available oral MS medication marketed by Sanofi as Aubagio. The investigational compound achieved its primary endpoints in both clinical investigations.
Results indicated that remibrutinib demonstrated superior efficacy compared to teriflunomide in decreasing annualized relapse rates among adult subjects diagnosed with relapsing multiple sclerosis. Additionally, the treatment exhibited clinically significant advantages in delaying the progression of physical disability.
According to Novartis, remibrutinib maintained a favorable safety and tolerability profile throughout both clinical trials. Notably, investigators observed no hepatotoxicity signals, aligning with safety observations from previous early-phase research.
Shreeram Aradhye, who serves as Novartis’s president of development and chief medical officer, emphasized the unmet medical need in this therapeutic area. He noted that physicians and patients continue seeking oral treatment alternatives that can effectively prevent relapses and slow disability accumulation while maintaining an acceptable safety margin.
“The positive REMODEL results underscore the potential of remibrutinib as a high-efficacy oral therapy for people living with RMS with a differentiated benefit-risk profile,” Aradhye said.
The pharmaceutical company announced its intention to submit regulatory applications worldwide seeking approval for remibrutinib. Comprehensive data from both trials are scheduled for presentation at an upcoming medical congress in Toronto.
Safety Concerns Trigger Rap-Cel Study Suspension
Coinciding with the positive MS announcement, Novartis disclosed that it had suspended eight clinical investigations of rap-cel, a distinct experimental treatment, in late August following three patient fatalities associated with severe immune system complications.
The clinical hold took effect on August 24. According to Novartis, the deaths resulted from a hyperactivated immune response causing the body to attack its own tissues and organsāa recognized risk associated with CAR-T cellular therapies.
Rap-cel represents a chimeric antigen receptor T-cell therapy that genetically engineers a patient’s own immune cells to identify and eliminate cells carrying specific markers. The suspended studies encompassed autoimmune conditions including systemic lupus erythematosus, rheumatoid arthritis, and vasculitis, along with neurological disorders such as multiple sclerosis and myasthenia gravis.
Novartis stated it is undertaking a comprehensive investigation of the adverse events in collaboration with independent data safety monitoring boards to determine causation and develop enhanced early detection protocols for serious adverse reactions.
Oncology Programs Continue Without Interruption
The company clarified that its two active rap-cel studies enrolling patients with lymphoma and leukemia remained operational and unaffected by the temporary suspension. Novartis indicated it is maintaining transparent communication with regulatory agencies and implementing enhanced surveillance for individuals who have already been treated.
The Wall Street Journal initially broke the story regarding the trial suspension. The publication additionally reported that Bristol Myers Squibb had implemented precautionary holds on comparable CAR-T investigations in autoimmune diseases. Bristol Myers Squibb declined to provide commentary when contacted.
Notwithstanding the rap-cel setback, market participants concentrated on the promising remibrutinib outcomes. Novartis shares traded approximately 4% higher on Tuesday.
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