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FDA Clears IND for Frevecitinib Asthma Inhaler
Frevecitinib is a novel inhaled dry powder therapeutic in development for asthma that remains inadequately controlled by SOC inhaled maintenance therapies.
The FDA has cleared Kinaset Therapeutics’ investigational new drug (IND) clearance for frevecitinib (KN-002), a novel inhaled dry powder therapeutic in development for patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies.1
"The unique mechanism of our inhaled pan-JAK inhibitor, combined with its targeted lung delivery and minimal systemic exposure, positions frevecitinib as a potentially transformative therapy for the treatment of severe asthma," Christopher O'Brien, MD, PhD, Chief Medical Officer, Kinaset Therapeutics, said in a statement.1 "Following positive Phase 1 results, we will continue development of a treatment that could significantly improve outcomes for patients whose severe asthma is inadequately controlled with ICS/LABA-based maintenance regimens. We're excited to build on these promising results as we advance into our Phase 2b program.”
Frevecitinib is a first-in-class inhaled single-capsule dry powder JAK inhibitor targeting JAK1, JAK2, JAK3 and TYK2, designed to deliver therapeutic lung concentrations while minimizing systemic exposure.
Kinaset Therapeutics seeks to address unmet treatment needs with patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies. These patients are typically prescribed medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), with or without additional controllers such as long-acting muscarinic antagonists (LAMA).
Frevecitinib previously demonstrated clinically relevant reductions in fractional exhaled nitric oxide (FeNO) in phase 1b studies including in participants with blood eosinophil counts below 300 cells/ mm³, as well as patients below 150 cells/mm³. The studies also demonstrated dose-proportional pharmacokinetics with plasma levels below pharmacologically active concentrations, aligning with the absence of systemic or local safety concerns. Kinaset plans to begin a Phase 2b dose ranging trial evaluating frevecitinib in mid-2025.
Other recent updates in asthma research includes a new study that demonstrated proof of concept of using nasal epithelial gene expression to identify asthma endotypes in young people. The study also revealed a predominant T2-low asthma endotype in ethnic minorities.2
Juan Celedón, MD, DrPH, professor of pediatrics, University of Pittsburgh and chief of pulmonary medicine, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh and colleagues sought to identify T helper 2 (T2) cells and T helper 17 (T17) cell endotypes of asthma in school-aged youths aged 6 to 20 years from 3 studies: Stress and Treatment Response in Puerto Rican and African American Children with Asthma (STAR; N = 156), Epigenetic Variation and Childhood Asthma in Puerto Ricans (EVA-PR; N = 237), and Vitamin D Kids Asthma (VDKA; N = 66).2
Celedón and colleagues identified 3 transcriptomic profiles: high T2 expression (T2HIGH), high T17 expression (T17HIGH), and low expression of both pathways (T2LOW/T17LOW). They found that across studies, T2HIGH was present in 23% to 29% of participants, T17HIGH in 35% to 47%, and T2LOW/T17LOW in 30% to 38%. Participants with the T2HIGH profile in each study had higher median total IgE and blood eosinophils than those with the T2LOW profiles (IgE, 584-869 vs 105-382 IU/mL; eosinophils, 343-560 vs 164-413 cells/mL).2
The investigators found that at least 50% of participants including all profiles had 1 or more positive allergen-specific IgEs. Using a differential expression meta-analysis, they identified 3516 and 2494 differentially expressed genes for the T2HIGH and T17HIGH profiles, respectvely. The T17HIGH profile was associated with interleukin 17 and neutrophil signaling pathways and the T2HIGH profile was associated with interleukin 13 signaling pathways.2
REFERENCES
Kinaset Therapeutics Announces FDA Clearance of IND Application for frevecitinib (KN-002) in Asthma Treatment. News release. Kinaset Therapeutics. January 29, 2025. https://www.businesswire.com/news/home/20250129156532/en/Kinaset-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-frevecitinib-KN-002-in-Asthma-Treatment
Yue M, Gaietto k, Han YY, et al. Transcriptomic Profiles in Nasal Epithelium and Asthma Endotypes in Youth. JAMA. 2025;333(4):307-318. doi:10.1001/jama.2024.22684
