BOSTON — Kinaset Therapeutics has dosed the first patient in a Phase 2b clinical trial evaluating frevecitinib, also known as KN-002, in patients with severe asthma that remains inadequately controlled despite medium- to high-dose inhaled corticosteroid and long-acting beta agonist therapy.
The randomized, double-blind and placebo-controlled PANAIRAMA trial will evaluate the efficacy, safety and pharmacokinetics of three doses of frevecitinib, an experimental inhaled pan-Janus kinase inhibitor.
Kinaset said the dose-ranging study is intended to identify an optimal treatment regimen that could support future pivotal clinical trials. Patients will be enrolled at multiple clinical sites in the United States and other countries.
“The dosing of the first patient with frevecitinib represents an important step forward in its clinical development,” said Christopher O’Brien, M.D., Ph.D., Chief Medical Officer of Kinaset Therapeutics. “Building on the strong foundation established by our Phase 1 program, we believe frevecitinib has the potential to be a first- and best-in-class inhaled therapy for patients whose asthma remains inadequately controlled with current treatment options. By targeting both Th2- and Th1-driven disease pathways, frevecitinib may address a broader population of patients and improve outcomes beyond current standards of care.”
Frevecitinib is designed to inhibit JAK1, JAK2, JAK3 and TYK2, proteins involved in inflammatory signaling. Kinaset is developing the drug as a maintenance treatment for patients whose asthma is not adequately controlled with standard inhaled therapies.
The company said delivering the drug directly to the lungs could provide therapeutic concentrations in lung tissue while limiting systemic exposure. Its mechanism is intended to address several inflammatory pathways associated with asthma, including Th2- and Th1-driven disease.
Kinaset said the treatment could potentially benefit patients with non-eosinophilic asthma, a population that may not respond to some existing therapies targeting eosinophilic or type 2 inflammation.
In a previous Phase 1 study, frevecitinib produced reductions in fractional exhaled nitric oxide, or FeNO, a biomarker used to measure airway inflammation. The study included patients with mild asthma, moderate-to-severe asthma and chronic obstructive pulmonary disease.
Frevecitinib also demonstrated dose-proportional pharmacokinetics in the Phase 1 study. According to Kinaset, plasma levels remained below concentrations expected to produce pharmacological effects throughout the body, consistent with the absence of significant systemic or local safety concerns observed to date.
The drug is formulated as a dry powder for inhalation and is designed to deliver an active dose directly to lung tissue through a single actuation. Kinaset said the drug’s chemistry and formulation were developed to address delivery challenges that have affected previous efforts to create inhaled JAK inhibitors.
The PANAIRAMA trial is listed on ClinicalTrials.gov under identifier NCT07532265.
