A phase 2b study will evaluate inhaled therapeutic in patients with inadequately controlled asthma despite medium-to-high dose inhaled corticosteroids and long-acting beta-agonists.
RT’s Three Key Takeaways:
- FDA Clears IND for Kinaset’s Inhaled Asthma Therapy – Frevecitinib is being developed for patients whose asthma remains uncontrolled despite standard inhaled maintenance treatments.
- Phase 2b Trial for Frevecitinib Set for 2025 – The study will assess dose-ranging efficacy and safety in patients using inhaled corticosteroids and long-acting beta-agonists.
- Early Data Supports Targeted Lung Delivery – Phase 1b results showed frevecitinib reduced airway inflammation while minimizing systemic exposure, supporting further clinical development.
Kinaset Therapeutics, a clinical-stage biopharmaceutical company developing inhaled therapeutics to treat serious respiratory diseases, announced that the United States Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for frevecitinib (KN-002).
This novel inhaled dry powder therapeutic is in development for 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 and long-acting beta-agonists, with or without additional controllers such as long-acting muscarinic antagonists.
Kinaset plans to begin a phase 2b dose-ranging trial in mid-2025.
Targeted Inhaled Therapy for Uncontrolled Asthma
Asthma, one of the most prevalent chronic respiratory conditions worldwide, affects millions of individuals, with nearly 50% of patients experiencing persistent symptoms despite standard treatment. Frevecitinib, a first-in-class inhaled pan JAK inhibitor targeting JAK1, JAK2, JAK3, and TYK2, is specifically formulated to deliver therapeutic lung concentrations through a single-capsule dry powder inhaler, while minimizing systemic exposure.
“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,” says Christopher O’Brien, MD, PhD, chief medical officer of Kinaset Therapeutics, in a release. “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.”
In phase 1b studies, frevecitinib demonstrated clinically relevant reductions in fractional exhaled nitric oxide—a key marker of airway inflammation—in patients with both mild asthma and moderate-to-severe asthma. These results included patients with blood eosinophil counts below 300 cells/ mm³, as well as patients below 150 cells/mm³, populations often less responsive to other therapies.
The phase 1b study also showed dose-proportional pharmacokinetics with plasma levels below pharmacologically active concentrations, aligning with the absence of systemic or local safety concerns. The upcoming phase 2b dose-ranging study is designed to select the optimal dose regimen for clinical development.
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