The Overview
Novartis is set to present 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, highlighting significant advancements in its multiple sclerosis (MS) portfolio. Key presentations include late-breaking Phase III REMODEL-1 and REMODEL-2 trial results for remibrutinib, an oral BTK inhibitor, demonstrating its efficacy and safety in relapsing MS. Additionally, new Kesimpta (ofatumumab) data will be unveiled, featuring Phase III NEOS study results in pediatric MS, where treatment options are limited. Further evidence from STHENOS, KATHAROS, and PRIM studies will expand Kesimpta's profile for treatment-naïve patients, breastfeeding, and pregnancy outcomes, reinforcing Novartis's commitment to addressing diverse unmet needs in MS.
Knolens Analysis
At a Glance
| Indication | Multiple sclerosis |
| Drug | Remibrutinib |
| Mechanism of Action | BTK inhibitor |
| Company | Novartis |
| Trial Phase | Phase III |
| Trial Acronym | REMODEL-1/-2 |
| Category | Clinical Trial Event |
| Sub Category | Topline Results Positive |
| Therapeutic Area | Neuroscience |
| Conference Name | MSToronto2026, 10th Joint ACTRIMS-ECTRIMS Meeting |
| Number of Abstracts | 46 |
| Comparator Drug (Remibrutinib) | Teriflunomide |
| Patient Population (Kesimpta NEOS) | Pediatric Multiple Sclerosis |
| Study Type (KATHAROS) | Breastfeeding study |
| Study Type (PRIM) | Pregnancy and Infant Outcomes study |
| Presentation ID (Remibrutinib) | O139 |
| Presentation ID (Kesimpta Pediatric MS) | O138 |
| Presentation Date (Remibrutinib) | October 23, 11:25 – 11:35 a.m. ET |
| Presentation Date (Kesimpta Pediatric MS) | October 23, 11:15 – 11:25 a.m. ET |
Novartis Unveils Late-Breaking Remibrutinib Phase III Data at MSToronto2026
Novartis is set to present 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, highlighting significant advancements in its multiple sclerosis (MS) portfolio. Key presentations include late-breaking Phase III REMODEL-1 and REMODEL-2 trial results for remibrutinib, an oral BTK inhibitor, demonstrating its efficacy and safety in relapsing MS. Additionally, new Kesimpta (ofatumumab) data will be unveiled, featuring Phase III NEOS study results in pediatric MS, where treatment options are limited. Further evidence from STHENOS, KATHAROS, and PRIM studies will expand Kesimpta's profile for treatment-naïve patients, breastfeeding, and pregnancy outcomes, reinforcing Novartis's commitment to addressing diverse unmet needs in MS.
- Novartis will present late-breaking Phase III REMODEL-1 and REMODEL-2 trial results for remibrutinib, an oral BTK inhibitor, at MSToronto2026. These studies evaluated the efficacy and safety of remibrutinib compared to teriflunomide in relapsing multiple sclerosis, with the data expected to underscore its potential as a significant therapeutic option in MS care.
- A second late-breaking abstract will feature new Kesimpta (ofatumumab) data from the Phase III NEOS study, focusing on its efficacy and safety in pediatric multiple sclerosis. This is particularly crucial given the limited approved treatment options currently available for this specific patient population, addressing a critical unmet medical need.
- Additional presentations will further expand the evidence base for Kesimpta, including final efficacy, safety, and healthcare resource utilization results from the Phase 3b STHENOS study in treatment-naïve relapsing MS patients. Interim results from the Phase 4 KATHAROS breastfeeding study and the PRIM study on pregnancy and infant outcomes will also be shared, providing valuable information for family planning decisions for women with MS.
Frequently Asked Questions
What is the latest news on multiple sclerosis?
The FDA approved ublituximab (Briumvi) in late 2022 for relapsing forms of multiple sclerosis, adding another anti-CD20 monoclonal antibody to the treatment landscape. Simultaneously, Phase 3 trials for several oral Bruton's tyrosine kinase (BTK) inhibitors, including tolebrutinib, evobrutinib, and remibrutinib, continue to be a major focus. These BTK inhibitors are closely watched for their potential to impact both relapsing and progressive MS by addressing CNS inflammation and smoldering disease.
How hard is it to live with MS?
Living with Multiple Sclerosis (MS) presents a highly variable and often significant challenge, ranging from mild symptoms to severe disability. Patients frequently contend with unpredictable relapses and progressive neurological deficits, including chronic fatigue, pain, motor dysfunction, cognitive impairment, and vision problems. These symptoms can profoundly impact daily activities, employment, and overall quality of life, necessitating ongoing disease-modifying therapies, symptom management, and rehabilitation. The unpredictable nature and potential for long-term disability contribute to a substantial physical, psychological, and socioeconomic burden for individuals and healthcare systems.
Is autophagy beneficial for multiple sclerosis?
Autophagy's role in multiple sclerosis is complex and context-dependent, exhibiting both protective and potentially detrimental effects. However, targeted modulation of autophagy pathways is considered a promising therapeutic strategy. This is due to its potential to clear myelin debris, reduce neuroinflammation, and promote neuroprotection and remyelination in various MS models.
What are the treatment options for multiple sclerosis (MS)?
Treatment for multiple sclerosis primarily involves disease-modifying therapies (DMTs) to reduce relapse frequency, severity, and slow disability progression. These include a range of injectable, oral, and infused agents targeting various immunological pathways. Acute relapses are typically managed with high-dose corticosteroids, while a variety of medications and non-pharmacological interventions address specific MS symptoms like fatigue, spasticity, and pain.
What is the best treatment for multiple sclerosis?
There is no single "best" treatment for multiple sclerosis, as therapeutic strategies are highly individualized based on disease type, activity, patient comorbidities, and risk tolerance. Disease-modifying therapies (DMTs) are the cornerstone of MS management, aiming to reduce relapse rates, slow disability progression, and minimize new lesion formation. The selection of a DMT involves a careful balance of efficacy, safety profile, and patient-specific factors, with a diverse and expanding armamentarium of high-efficacy options available.
How do you accept you have MS?
Accepting an MS diagnosis is a complex, ongoing psychological process, not a singular event. It involves grieving the loss of previous health, adjusting to new physical limitations, and integrating the disease into one's identity. This journey often requires developing new coping strategies, seeking emotional support from healthcare professionals or peer groups, and adapting daily life to manage symptoms and disease progression. Ultimately, acceptance means acknowledging the reality of MS while focusing on proactive management and maintaining quality of life.
Do people with MS still work?
Many individuals with multiple sclerosis (MS) continue to work, though employment rates are significantly lower compared to the general population. Disease progression, symptom burden (e.g., fatigue, cognitive impairment), and disability accumulation often lead to reduced work hours or early retirement. However, advancements in disease-modifying therapies and improved symptom management strategies, alongside workplace accommodations, enable many to maintain employment for extended periods. The ability to work varies widely depending on disease subtype, individual circumstances, and access to supportive resources.
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