Amlitelimab

AstraZeneca's Breztri Shows Significant Improvement in Phase III Asthma Trials

20 days ago

• Breztri Aerosphere met all primary endpoints in KALOS and LOGOS Phase III trials, demonstrating statistically significant improvement in lung function for patients with uncontrolled asthma compared to dual-combination therapies. • The triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate) could potentially address a critical unmet need, as nearly half of asthma patients on dual therapy remain uncontrolled. • AstraZeneca plans to share the full trial results with regulatory authorities, potentially expanding Breztri's approved indications beyond its current use in COPD treatment across 80+ countries.

Sanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma

a month ago

• Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study. • The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026. • Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.

Sanofi Acquires Dren Bio's Novel B-Cell Depleter for $600 Million, Expanding Immunology Pipeline

2 months ago

• Sanofi has agreed to acquire Dren Bio's DR-0201, a first-in-class bispecific myeloid cell engager that induces deep B-cell depletion, for an upfront payment of $600 million. • DR-0201 works by targeting CD20 and engaging tissue-resident myeloid cells, potentially resetting the immune system in patients with refractory B-cell mediated autoimmune diseases like lupus. • The acquisition strengthens Sanofi's immunology portfolio and includes potential future payments of $1.3 billion upon achievement of development and launch milestones, with transaction expected to close in Q2 2025.

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.

Sanofi's Amlitelimab Advances to Long-Term Safety Study for Atopic Dermatitis Treatment in India

4 months ago

Sanofi Healthcare India has received approval from CDSCO's Subject Expert Committee to conduct a Phase II/III long-term extension study of amlitelimab in adults with moderate to severe atopic dermatitis. The study aims to evaluate the novel anti-OX40L monoclonal antibody's safety, tolerability, and efficacy in addressing this inflammatory skin condition with significant unmet medical needs.

Sanofi Aims to Expand Atopic Dermatitis Market Presence with Novel Therapies

4 months ago

• Sanofi's Dupixent achieved over $13 billion in global sales, establishing it as a gold standard in atopic dermatitis (AD) treatment. • Sanofi is developing SAR444656 (KT-474), an IRAK4 degrader in Phase II trials, in collaboration with Kymera Therapeutics, with data expected in H1 2025. • Amlitelimab, an anti-OX40L monoclonal antibody, is in Phase III trials, showing promise in reshaping the AD treatment landscape and increasing competition. • Sanofi's strategic focus on innovation and pipeline development aims to maintain its competitive edge in the expanding atopic dermatitis market.

Advancements in Acute Lymphocytic Leukemia (ALL) Treatment Landscape

5 months ago

• The FDA approved obecabtagene autoleucel (Aucatzyl) for adults with relapsed or refractory B-cell precursor ALL, marking a significant advancement in CAR T-cell therapy. • A pivotal clinical trial revealed transformative findings poised to change the standard of care for children with acute lymphoblastic leukemia (ALL), marking a milestone in pediatric oncology. • Pfizer's BESPONSA received FDA approval for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell ALL, expanding treatment options for this population.

TIDE-Asthma Study Identifies Strategies for Enhancing Racial and Ethnic Diversity in Clinical Trials

6 months ago

• The TIDE-Asthma study successfully employed specific enrollment strategies to boost racial and ethnic diversity, particularly among Hispanic and Asian patient populations. • Key opinion leaders within diverse communities played a crucial role in outreach and awareness, aiding in the identification of suitable clinical trial sites. • The study achieved its diversity enrollment goals by focusing on site selection in high-prevalence areas and providing comprehensive support to both sites and patients. • Lessons learned from the TIDE-Asthma study are now being applied to enhance diversity in other clinical trials across various indications at Sanofi.

Sanofi's Q3 Sales Surge 15.7% Driven by Vaccines and Dupixent; 2024 EPS Guidance Raised

7 months ago

• Sanofi reported a robust 15.7% sales growth in Q3, fueled by strong vaccine sales and the continued success of Dupixent, with sales up 23.8% to €3,476 million. • Pharma launches, including ALTUVIIIO, Nexviazyme, and Rezurock, saw a significant 67.1% increase, contributing €727 million to the overall sales growth. • The company's pipeline advanced with four regulatory approvals, including Dupixent for COPD in the US and China, and four positive Phase 3 data readouts, including tolebrutinib for nrSPMS. • Based on strong Q3 business performance, Sanofi has raised its 2024 business EPS guidance to at least a low single-digit percentage growth at CER.

Sanofi Presents New Data on Dupixent and Immunology Pipeline at EADV 2024

8 months ago

• Sanofi presented 21 abstracts for Dupixent, highlighting its impact on atopic dermatitis, prurigo nodularis and chronic spontaneous urticaria, showcasing disease remission and long-term efficacy data. • Data from an open-label extension study showed Dupixent's potential for clinical remission in children aged 6-17 with moderate-to-severe atopic dermatitis, even after stopping treatment. • Sanofi shared data from its immunology pipeline, including amlitelimab, an OX40-ligand monoclonal antibody, demonstrating safety and efficacy in moderate-to-severe atopic dermatitis with potential for quarterly dosing. • Rilzabrutinib, a novel oral BTK inhibitor, showed positive impacts on symptoms of atopic dermatitis and moderate-to-severe chronic spontaneous urticaria in poster presentations.

Drug Development Updates