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InnoCare's Orelabrutinib Shows Over 90% Reduction in MS Brain Lesions in Phase II Trial

• Orelabrutinib demonstrated remarkable efficacy in Phase II trials, reducing new brain lesions by 90.4% at 12 weeks and 92.3% at 24 weeks compared to placebo in RRMS patients.

• The BTK inhibitor, administered at 80mg once daily, showed promising results for relapsing-remitting multiple sclerosis treatment, marking a significant advancement in MS therapy.

• InnoCare Pharma presented these breakthrough findings at the ACTRIMS Forum 2025, positioning the company as an emerging leader in neuroimmunology therapeutics.

InnoCare Pharma has achieved a significant breakthrough in multiple sclerosis treatment with their investigational drug orelabrutinib, reporting exceptional Phase II clinical trial results. The brain-penetrant BTK inhibitor demonstrated remarkable efficacy in reducing new brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS).

Significant Clinical Efficacy Data

The Phase II trial results, presented at the ACTRIMS Forum 2025, revealed that orelabrutinib, administered at 80 mg once daily, achieved a striking reduction in new brain lesions compared to placebo. The data showed a 90.4% reduction at the 12-week mark, which further improved to 92.3% at 24 weeks, demonstrating both rapid onset and sustained therapeutic effect.

Novel Therapeutic Approach

Orelabrutinib represents a new generation of highly selective BTK inhibitors designed to effectively cross the blood-brain barrier. This characteristic is particularly crucial for treating multiple sclerosis, where central nervous system penetration is essential for therapeutic efficacy.

Treatment Implications

The robust efficacy data from this Phase II trial suggests orelabrutinib could potentially offer a significant advancement in the treatment landscape for RRMS patients. The once-daily oral dosing regimen could provide a convenient treatment option compared to existing therapies.

Market Impact and Future Prospects

These promising results have positioned InnoCare Pharma as an emerging leader in the multiple sclerosis treatment space. The company's focus on developing innovative neuroimmunology treatments, particularly targeting multiple sclerosis and related disorders, demonstrates their commitment to addressing unmet medical needs in this therapeutic area.
The successful Phase II results mark a crucial milestone in orelabrutinib's development program and set the stage for potential advancement to Phase III trials. This development could significantly impact the competitive landscape of MS therapeutics, offering new hope for patients seeking effective treatment options.
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Related Clinical Trials

A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis

NCT04711148Active, Not RecruitingPhase 2
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 3/1/2021

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