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American Academy of Neurology (AAN) 2024 Annual Meeting | News | Updates | iPharmaCenter

Fresh 48-Week Data Reveals Promising Data of Frexalimab in Phase 2 Trial for Multiple Sclerosis

Recently released 48-week data from a phase 2 trial highlights the potential of frexalimab as a long-term, high-efficacy treatment for multiple sclerosis (MS). This data underscores the significance of frexalimab as a potential pioneer in non-lymphocyte-depleting therapies for relapsing MS.

Participants receiving a high dosage of intravenous frexalimab demonstrated impressive results after 48 weeks, with 96% showing no new Gd+ T1 lesions and experiencing an annualized relapse rate of just 0.04. These outcomes are promising indicators of sustained efficacy over an extended treatment period.

The phase 2 trial, conducted as a randomized, double-blind, placebo-controlled study, assessed the efficacy of frexalimab in participants with relapsing MS. Participants were randomly assigned to different dosage regimens of frexalimab or a placebo for 12 weeks. The primary endpoint was the reduction in new Gd+ T1 MRI brain lesions at the end of this period.

Following the initial 12-week phase, a vast majority of participants entered the open-label extension (OLE) of the study. Throughout the 48-week period, participants receiving Frexalimab maintained low levels of Gd+ T1 lesions, with 87% remaining in the study at the endpoint.

Key findings from the 48-week extension include:

  • The continued absence of Gd+ T1 lesions in 96% of patients on high-dose frexalimab and 87% on low-dose frexalimab

  • Sustained reduction in Gd+ T1-lesions for those who switched from placebo to frexalimab

  • Low annualized relapse rates (ARR) in participants receiving high-dose Frexalimab, further highlighting its efficacy over the treatment period

  • Overall, frexalimab demonstrated a favourable safety profile throughout the 48 weeks, indicating its potential as a well-tolerated long-term treatment option for MS

Frexalimab (SAR441344) acts as a second-generation anti-CD40L antibody, targeting the CD40/CD40L pathway crucial for immune cell activation and function. Unlike traditional therapies, frexalimab's unique mechanism of action aims to tackle both acute and chronic neuroinflammation without causing lymphocyte depletion. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc., with ongoing phase 3 trials in MS and phase 2 trials in immunology indications and Type 1 Diabetes.


Roche's Ocrevus Shows Remarkable Efficacy in One-Year Subcutaneous Injection Data for MS Patients

Recent findings from the Phase III OCARINA II trial unveiled promising results for Roche's Ocrevus (ocrelizumab) administered via subcutaneous (SC) injection. The study demonstrated near-complete suppression of clinical relapses and brain lesions in individuals with relapsing or primary progressive multiple sclerosis (RMS or PPMS), reinforcing the potential of this new formulation.

The data revealed that the SC injection, administered twice yearly in a brief 10-minute procedure, yielded outcomes consistent with intravenous (IV) infusion. Over the course of 48 weeks, the SC injection led to a remarkable 97% suppression of relapse activity and 97.2% reduction in MRI lesions. These results underscore the efficacy and potential of the SC formulation, offering a viable alternative for patients and healthcare facilities lacking IV infrastructure or facing capacity limitations.

Regulatory bodies, including the U.S. FDA and EMA, have accepted filings based on the OCARINA II data. Anticipated approvals include EU approval by mid-2024 and U.S. approval by September 2024, marking significant milestones in expanding treatment options for MS patients.

Longer-term data from the trial further supported the efficacy and safety of Ocrevus SC injection. Patients experienced sustained suppression of relapse activity, with an annualized relapse rate (ARR) of 0.04 over the treatment period. Additionally, the majority of patients exhibited no T1 gadolinium-enhancing (T1 Gd+) lesions or new/enlarging T2 lesions, indicating reduced inflammation and disease burden.

Exploratory patient-reported outcome measures revealed high levels of satisfaction and convenience with Ocrevus SC injection, with over 90% of patients expressing satisfaction and convenience with the treatment regimen.

Safety data indicated that Ocrevus SC injection maintained a consistent safety profile comparable to IV infusion. Common adverse events, such as injection reactions, were mostly mild or moderate and did not result in treatment discontinuation. Serious adverse events were rare and comparable between the SC injection and IV infusion groups.

The OCARINA II trial abstract received recognition as an abstract of distinction by the AAN, highlighting its quality and significance to the neurology community.

Overall, the introduction of the twice-yearly SC injection offers a promising advancement in MS treatment, potentially expanding access to Ocrevus for patients and healthcare facilities worldwide. With regulatory approvals on the horizon, Ocrevus SC injection stands poised to make a significant impact on the management of MS.


Novartis Unveils Six-Year Efficacy Data for Kesimpta in Relapsing Multiple Sclerosis Patients

Novartis has revealed compelling findings from the ALITHIOS open-label extension study, showcasing the sustained efficacy of Kesimpta (ofatumumab) over six years in individuals recently diagnosed with relapsing multiple sclerosis (RMS) and those who are treatment-naïve. This analysis specifically targeted individuals who commenced treatment within three years of their initial diagnosis.

The data demonstrated remarkable outcomes, with continuous Kesimpta treatment resulting in significant reductions in relapse rates, MRI lesions (both Gd+ T1 and neT2), and disability worsening events compared to those who switched from teriflunomide to Kesimpta. The study illustrated a 44% decrease in relapses, along with substantial reductions in MRI lesion activity and disability worsening events over the six-year period.

Among individuals initially randomized to teriflunomide, transitioning to Kesimpta showed notable improvements in various efficacy measures, including a significant decrease in relapse rates and MRI lesion activity. However, disability-worsening events remained more prevalent in this group compared to those receiving continuous Kesimpta, suggesting a superior efficacy in delaying disability progression with first-line Kesimpta treatment.

Moreover, the data from the overall ALITHIOS population echoed the sustained efficacy of Kesimpta over six years, highlighting consistent reductions in relapse rates, MRI lesion activity, and disability worsening events. Individuals switching from teriflunomide to Kesimpta also experienced significant improvements in these parameters, albeit with higher rates of disability worsening compared to the continuous Kesimpta group.

Despite these differences, the study emphasized the remarkable achievement of maintaining no evidence of disease activity (NEDA-3) in the vast majority of participants across both continuous and switch groups, underscoring the enduring efficacy of Kesimpta in RMS management. These findings further reinforce the favourable benefit-risk profile of Kesimpta as a first-line treatment option for individuals with relapsing MS.


New 48-week findings from a phase 2 trial highlight the potential of frexalimab in providing sustained efficacy for individuals with multiple sclerosis (MS)

Frexalimab, a CD40L antibody developed by Sanofi, demonstrated sustained reduction in disease activity and favorable tolerability in participants with relapsing MS. The study enrolled 129 participants, with 97% transitioning to the open-label extension (OLE) phase after the initial 12-week double-blind period. At the 48-week mark, 87% of participants remained in the study.

Results from the OLE phase at week 48 revealed promising outcomes:

  • 96% of patients on high-dose frexalimab and 87% on low-dose frexalimab were free of Gd+ T1 lesions.

  • The number of Gd+ T1 lesions remained low across all treatment groups.

  • The annualized relapse rate (ARR) for those on high-dose frexalimab was 0.04, with 96% being relapse-free.

Frexalimab demonstrated good tolerability throughout the study period, with common adverse events including nasopharyngitis, headache, and COVID-19.

The phase 2 trial was a randomized, double-blind, placebo-controlled study evaluating frexalimab in participants with relapsing MS. After the initial 12 weeks, participants receiving placebo switched to frexalimab and entered the open-label extension phase.

Frexalimab, a potentially first-in-class anti-CD40L antibody, works by blocking the CD40/CD40L pathway without causing lymphocyte depletion. Sanofi has initiated global phase 3 studies of frexalimab for both relapsing MS and non-relapsing secondary progressive MS. Frexalimab is also being evaluated in phase 2 studies for immunology indications and Type 1 Diabetes.


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