Remibrutinib

24+ Companies Advancing Hidradenitis Suppurativa Treatment Pipeline with Novel Therapies

16 days ago

• DelveInsight's 2025 report reveals a robust pipeline with 24+ companies developing 24+ therapies for hidradenitis suppurativa, a chronic inflammatory skin condition affecting hair follicles. • Key players including InflaRx, Novartis, UCB, and Boehringer Ingelheim are advancing treatments targeting various inflammatory pathways with monoclonal antibodies and small molecules. • Novel mechanisms of action include targeting IL-36R (spesolimab), C5a (vilobelimab), IL-17A (secukinumab), and BTK inhibition (remibrutinib), offering hope for patients with limited treatment options.

Novel Therapies Show Promise for Chronic Spontaneous Urticaria with Complete Response Rates Exceeding 30%

2 months ago

• Recent clinical trials demonstrate that emerging therapies including dupilumab, remibrutinib, and barzolvolimab achieve complete response rates of 28-51% in patients with chronic spontaneous urticaria (CSU) who are resistant to standard treatments. • Remibrutinib, a novel oral Bruton tyrosine kinase inhibitor, showed rapid improvement in urticaria control as early as week 2 in phase 3 REMIX trials, with approximately 64% of patients achieving well-controlled disease by week 24. • Long-term safety data for omalizumab reveals virtually no risk of anaphylaxis or serum sickness after 2.5 million injections over two decades, establishing its continued importance in the treatment landscape for severe allergic conditions.

Dupilumab Shows Strong Efficacy in Chronic Spontaneous Urticaria Across All BMI Ranges

3 months ago

• Phase 3 LIBERTY-CSU CUPID trials demonstrate dupilumab's effectiveness in reducing itch and urticaria activity in patients unresponsive to H1-antihistamines. • Clinical benefits of dupilumab were consistent across all BMI ranges, including patients in obese categories, providing important efficacy data for diverse patient populations. • FDA review of dupilumab for chronic spontaneous urticaria is underway with a target action date of April 18, 2025, potentially offering a new treatment option for resistant cases.

Remibrutinib Shows Promising Long-term Efficacy in Phase 3 Trials for Chronic Spontaneous Urticaria

3 months ago

• Remibrutinib demonstrated rapid symptom improvement in chronic spontaneous urticaria patients, with significant disease activity score reductions observed as early as week 1 of treatment. • Nearly 50% of patients achieved complete symptom resolution (UAS7=0) by week 52, highlighting the drug's sustained therapeutic effect in long-term treatment. • The BTK inhibitor maintained a favorable safety profile throughout the 52-week study period in both REMIX-1 and REMIX-2 trials.

Sanofi to Present Extensive Immunology Data at AAAAI 2025, Highlighting Dupixent and Pipeline Advances

4 months ago

• Sanofi will showcase 24 abstracts at AAAAI 2025, including new pooled results from Dupixent's phase 3 trials in chronic spontaneous urticaria and data across multiple inflammatory conditions. • New phase 2 data for rilzabrutinib, an investigational oral BTK inhibitor, will demonstrate its potential in treating moderate-to-severe chronic spontaneous urticaria patients. • The presentations will include four oral sessions and a late-breaking poster, covering diseases such as asthma, COPD, CRSwNP, and eosinophilic esophagitis.

Chronic Spontaneous Urticaria Market Expected to Reach $36 Billion by 2035 as Novel Targeted Therapies Transform Treatment Landscape

4 months ago

• The global chronic spontaneous urticaria (CSU) market is projected to grow from $15.1 million in 2024 to $36 billion by 2035, driven by rising diagnosis rates and innovative biologic therapies. • Pharmaceutical giants including Novartis, Sanofi, Roche, and AstraZeneca are advancing promising treatments beyond traditional antihistamines, with BTK inhibitors like remibrutinib and rilzabrutinib showing significant potential in clinical trials. • Treatment paradigms are shifting from conventional approaches toward personalized medicine and targeted therapies, offering new hope for the approximately 2.8 million CSU patients across major markets who often experience inadequate symptom control.

Allakos Halts AK006 Development for Chronic Hives After Phase 1 Failure, Announces Restructuring

4 months ago

• Allakos' AK006 failed to demonstrate therapeutic efficacy in a Phase 1 trial for chronic spontaneous urticaria (CSU), leading to the discontinuation of its development. • The company will reduce its workforce by 75% and explore strategic alternatives following the unsuccessful trial results. • The Phase 1 trial enrolled 34 patients with moderate-to-severe CSU, but AK006 did not show significant improvement compared to placebo. • Allakos anticipates restructuring costs of $34 million to $38 million and expects to have $35 million to $40 million in cash reserves by mid-2025.

Novartis Focuses on Immunology and Gene Therapies for Future Growth

4 months ago

• Novartis is prioritizing immunology with expectations of multiple Phase II and Phase III readouts in the next five years, signaling a strong pipeline in this area. • The company is expanding its gene therapy capabilities through acquisitions like Kate Biotherapeutics, acquired for $1.1 billion in November 2024. • Novartis is streamlining its portfolio to concentrate on key therapeutic areas, aiming to drive future growth and innovation in specific sectors.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). • The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo. • Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression. • Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.

Novartis and Apellis Advance C3G Therapies Towards FDA Submission

6 months ago

• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions. • Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients. • Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments. • Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

Urticaria Clinical Trial Pipeline Heats Up with Novel Therapies in Development

7 months ago

• The urticaria treatment landscape is evolving, with over 20 companies developing more than 25 novel therapies to address unmet patient needs. • Regeneron and Sanofi's Dupixent demonstrated positive Phase III results for chronic spontaneous urticaria, showing promise for biologic-naive patients. • Evommune initiated a Phase II trial of EVO756 for chronic inducible urticaria, while Celldex Therapeutics reported positive Phase II data for barzolvolimab in chronic spontaneous urticaria. • Emerging therapies target various mechanisms, including IgE, mast cells, and kinases, offering diverse approaches to urticaria management.

Dupixent Shows Promise in Phase 3 Trial for Chronic Spontaneous Urticaria

8 months ago

• Dupixent met primary and key secondary endpoints in a Phase 3 trial for chronic spontaneous urticaria (CSU) patients uncontrolled on antihistamines. • The LIBERTY-CUPID Study C demonstrated a nearly 50% reduction in itch and urticaria activity scores compared to placebo. • Sanofi and Regeneron plan to resubmit data to the FDA, potentially making Dupixent the first targeted CSU therapy in a decade if approved.

Inclisiran Demonstrates Significant LDL-C Lowering in V-MONO Trial

9 months ago

• Inclisiran monotherapy significantly reduced LDL-C levels compared to placebo and ezetimibe in patients with low to moderate ASCVD risk. • The Phase III V-MONO study met its primary endpoints, showcasing inclisiran's superiority in LDL-C reduction. • Novartis plans to present the V-MONO trial results to regulatory agencies, including the FDA, for potential label expansion. • The V-MONO trial is part of the larger VictORION program, which includes over 60,000 patients across more than 30 trials.

Systematic Review of Phase II and III Clinical Trials for Relapsing Multiple Sclerosis

a year ago

A comprehensive systematic review of phase II and III clinical trials for relapsing multiple sclerosis (RMS) has been conducted, focusing on trial designs and primary endpoints. The review, which analyzed 60 trials from three major trial registration systems, highlights the dominance of randomized controlled parallel-arms trials and discusses the most common primary endpoints across different trial phases and patient groups. The findings suggest a need for revisions in regulatory guidelines and expert recommendations to better align with current clinical trial practices.

Drug Development Updates