Sanofi Shares Positive Phase 2 Asthma Drug Data; Explores Broader Use for Other Respiratory Candidates
Respiratory Drug News and Advancements
Sanofi announced new positive data from its Phase 2 TIDE-Asthma study for amlitelimab, an investigational drug for moderate-to-severe asthma. While the primary endpoint wasn't met at the highest dose, the medium dose showed clinically meaningful reductions in asthma exacerbations and improvements in lung function and asthma control in patients with heterogeneous inflammatory asthma. Notably, a biomarker-defined subgroup (high eosinophils and neutrophils) experienced a significant 70% reduction in exacerbations. Amlitelimab, with its novel non-depleting mechanism targeting OX40-Ligand, is being developed for quarterly maintenance dosing. Phase 3 trials are being planned. Sanofi is also exploring its other respiratory drug, lunsekimig, for potential use in COPD and chronic rhinosinusitis, in addition to asthma. Itepekimab, another Sanofi drug, is being investigated for COPD, chronic rhinosinusitis, and bronchiectasis, with Phase 3 COPD results expected in the second half of 2025.
New 3D Lung Model Could Revolutionize Inhalable Drug Development
Researchers at the University of Delaware have developed an innovative 3D lung model that can mimic realistic breathing patterns. This model can be used to personalize the evaluation of aerosol therapeutics under various breathing conditions. The researchers have filed a patent for their invention. The model allows for a deeper understanding of how inhaled medications behave in different parts of the lung, potentially predicting the effectiveness of these medications for diverse patient populations and age groups. This technology could help optimize drug formulation and reduce setbacks in clinical trials by determining if the aerosol reaches the targeted areas in the correct amount.
Air Pollution in Delhi Drives Surge in Respiratory Drug Sales
As air quality worsened significantly in Delhi, demand for respiratory medications surged. Foracort, an inhaler used for asthma and COPD, became the top-selling medicine in India in October 2024. Sales reached ₹75 crore, surpassing other leading drugs. Foracort, manufactured by Cipla, combines a corticosteroid (budesonide) to reduce inflammation and a bronchodilator (formoterol) to widen airways. Experts highlight its dual-action as key to managing symptoms and reducing hospital visits. Other respiratory drugs like Duolin and Budecort also saw increased sales. This spike underscores the urgent need for healthcare solutions and long-term strategies to combat air pollution.
Respiratory Drug Market Sees Significant Growth
The respiratory drug market experienced a significant increase in sales, reaching ₹1,638 crore in November 2024, up from ₹989 crore in June. This 66% jump over five months was driven by increased pollution-related illnesses and seasonal changes (monsoon and winter), leading to a rise in asthma, COPD, and cough and cold cases. Pharmarack data indicates a steady rise in sales from July onwards. Medical experts reported a nearly 50% increase in respiratory and pulmonary outpatient department visits in major North Indian hospitals. This trend highlights the seasonal nature of respiratory illnesses and the impact of environmental factors on drug demand.
Key Trends and Advancements in Respiratory Drugs:
Targeted Biologics: Monoclonal antibodies like amlitelimab are emerging as effective treatments for severe asthma by targeting specific immune pathways, offering personalized approaches with fewer side effects. Dupilumab has also been approved as maintenance therapy for certain types of COPD.
Novel Drug Delivery Systems: Innovations like nanoparticle-based delivery systems aim to improve drug efficacy by enhancing targeted delivery to the lungs, increasing drug retention, and reducing systemic toxicity. Various nanoparticle types are being explored for asthma, COPD, pulmonary fibrosis, and lung cancer.
Inhaler Technology Advancements: Smart inhalers with sensors and Bluetooth connectivity are improving medication adherence and technique by providing real-time feedback to patients and healthcare providers. Advancements in dry powder and metered-dose inhalers are also enhancing drug deposition in the lungs.
Personalized Medicine: The understanding that respiratory conditions are unique to each patient is driving the development of targeted therapies based on individual genetic profiles and biomarkers, particularly in asthma and lung cancer.
Gene and Cell Therapies: Gene editing techniques like CRISPR-Cas9 and stem cell therapies are being explored for their potential to treat the underlying causes of genetic respiratory disorders and to promote lung regeneration in conditions like idiopathic pulmonary fibrosis.
mRNA Vaccines: The approval of mRNA vaccines like Moderna's mRESVIA for respiratory syncytial virus (RSV) in older adults marks a significant advancement in preventing lower respiratory tract diseases.
Fixed-Dose Combinations: The launch of triple combination drugs like Lupin's Vilfuro-G for COPD in India aims to simplify treatment regimens and improve patient outcomes.
Long-Acting Bronchodilators and Muscarinic Antagonists (LAMAs): Newer LABAs and LAMAs with once-daily dosing options and faster onset of action are improving the management of COPD. Combinations of LABAs, ICSs, and LAMAs are also being investigated.
3D Lung Models: Advanced in-vitro models that mimic lung physiology and breathing mechanics are becoming valuable tools for preclinical drug development and for understanding drug behavior in the respiratory system.
Digital Health and Telemedicine: Remote monitoring tools, digital spirometers, and telemedicine platforms are improving disease management for chronic respiratory conditions by enabling timely interventions and access to specialized care.