Kinaset Therapeutics Announces First Patient Dosed in Phase 2b PANAIRAMA Trial of frevecitinib (KN-002) in Patients with Severe Asthma

Dose-ranging study evaluating potential first- and best-in-class inhaled pan-JAK inhibitor in patients receiving medium-to-high dose ICS/LABA therapy

BOSTON--(BUSINESS WIRE)--Kinaset Therapeutics, a clinical-stage biopharmaceutical company developing inhaled therapeutics to treat serious respiratory diseases, today announced the first patient has been dosed in its Phase 2b clinical trial evaluating frevecitinib, a novel inhaled pan JAK inhibitor, in patients with severe asthma inadequately controlled despite treatment with medium-to-high dose inhaled corticosteroid long-acting beta agonist (ICS/LABA) therapy.

PANAIRAMA is a randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate the efficacy, safety and pharmacokinetics of three doses of frevecitinib. The study is intended to identify the optimal dose regimen to support future pivotal clinical development. The trial will enroll patients across multiple clinical sites in the United States and internationally. Additional information about the PANAIRAMA study is available at ClinicalTrials.gov under identifier NCT07532265.

“The dosing of the first patient with frevecitinib represents an important step forward in its clinical development,” said Christopher O’Brien, MD, PhD, 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.”

Asthma remains one of the most prevalent chronic respiratory diseases globally, and many patients continue to experience persistent symptoms, impaired lung function and exacerbations despite available maintenance therapies. Frevecitinib is the only inhaled pan-JAK inhibitor targeting JAK1, JAK2, JAK3 and TYK2 in clinical development. By delivering therapeutic concentrations directly to the lungs while limiting systemic exposure, frevecitinib has the potential to address multiple inflammatory pathways implicated in asthma, including Th2- and Th1-driven disease, and may offer a new treatment approach in patients with non-eosinophilic asthma who remain underserved by current therapies.

In a prior Phase 1 study, frevecitinib demonstrated clinically meaningful reductions in fractional exhaled nitric oxide (FeNO), a biomarker of airway inflammation, in patients with mild asthma, moderate-to-severe asthma and chronic obstructive pulmonary disease (COPD). Frevecitinib also demonstrated dose-proportional pharmacokinetics with plasma levels remaining below pharmacologically active systemic concentrations, consistent with the absence of significant systemic or local safety concerns observed to date.

About frevecitinib
Frevecitinib is a novel, potential best-in-class inhaled pan-JAK inhibitor (JAK1, JAK2, JAK3, TYK2) that is being developed as a maintenance treatment for patients whose asthma remains inadequately controlled on standard inhaled therapies. With its broad mechanism of action, frevecitinib has the potential to address multiple inflammatory pathways implicated in asthma, including both Th2- and Th1-driven disease, and may help address an important limitation of existing treatment options. Frevecitinib was designed through an integrated chemistry and formulation strategy intended to overcome drug delivery challenges that have limited prior attempts to develop inhaled JAK inhibitors. The molecule is formulated as a dry powder for inhalation and is designed to deliver pharmacologically active concentrations directly to lung tissue while minimizing systematic exposure. Unlike other inhaled JAK inhibitor candidates, frevecitinib is intended to deliver therapeutic doses through a single actuation.

About Kinaset Therapeutics, Inc.
Kinaset Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel inhaled therapies for patients with severe respiratory diseases. The Company’s lead program, frevecitinib, is a differentiated inhaled pan-JAK inhibitor designed to deliver broad anti-inflammatory activity directly to the lungs while limiting systemic exposure. Frevecitinib is being developed for patients with serious respiratory conditions including asthma that remains inadequately controlled by standard inhaled maintenance therapies. For more information, visit the Company’s website.