According to Kinaset Therapeutics, the FDA has cleared the company’s IND for a Phase 2b trial of its KN-002 frevecitinib dry powder inhaler. The 12-week Phase 2 trial, which will evaluate 3 doses of dry powder frevecitinib in patients with severe asthma that is not adequately controlled by ICS / LABA therapy, is expected to get underway in mid-2025. Kinaset acquired development rights to KN-002 (formerly VR588) from Vectura in 2020.
A Phase 1 trial of KN-002 that was initiated in mid-2021 was completed in mid-2024 and demonstrated dose-dependent PK and “plasma levels below pharmacologically active concentrations, aligning with the absence of systemic or local safety concerns,” the company said. According to the study record, the trial enrolled 117 subjects, with one group of healthy subjects; another with patients with stable asthma; a third enrolled patients with moderate-to-severe asthma; and a fourth consisting of patients with COPD. Kinaset notes that both of the asthma groups experienced reductions in fractional exhaled nitric oxide that were clinically relevant.
Kinaset Chief Medical Officer Christopher O’Brien commented, “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. 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.”
Read the Kinaset press release
