Kinaset Therapeutics Doses First Patient in Phase 2b PANAIRAMA Trial of Inhaled Pan-JAK Inhibitor Frevecitinib for Severe Asthma
核心洞察
Kinaset Therapeutics (搜索) has dosed the first patient in its Phase 2b PANAIRAMA trial evaluating frevecitinib, a novel inhaled pan-JAK inhibitor, in patients with severe asthma (搜索) inadequately controlled on ICS/LABA therapy.
The randomized, double-blind, placebo-controlled dose-ranging study will assess efficacy, safety, and pharmacokinetics of three frevecitinib doses across U.S. and international sites.
Frevecitinib is the only inhaled pan-JAK inhibitor targeting JAK1 (搜索), JAK2 (搜索), JAK3 (搜索), and TYK2 (搜索) in clinical development, designed to address both Th2- and Th1-driven inflammatory pathways.
Kinaset Therapeutics (搜索), a clinical-stage biopharmaceutical company focused on inhaled therapies for serious respiratory diseases, announced today that the first patient has been dosed in its Phase 2b PANAIRAMA trial evaluating frevecitinib (KN-002), a novel inhaled pan-JAK inhibitor, in patients with severe asthma (搜索) that remains inadequately controlled despite treatment with medium-to-high dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) therapy.
The milestone marks a significant advancement for what could become the first-in-class inhaled pan-JAK inhibitor, targeting all four JAK family members — JAK1 (搜索), JAK2 (搜索), JAK3 (搜索), and TYK2 (搜索) — directly at the site of airway inflammation.
Trial Design and Objectives
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 trial aims to identify the optimal dose regimen to support future pivotal clinical development and will enroll patients across multiple clinical sites in the United States and internationally. Additional details are 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 (搜索). "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."
Mechanism and Differentiation
Frevecitinib is formulated as a dry powder for inhalation and 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. Unlike other inhaled JAK inhibitor candidates, frevecitinib is intended to deliver therapeutic doses through a single actuation, delivering pharmacologically active concentrations directly to lung tissue while minimizing systemic exposure.
By targeting both Th2- and Th1-driven disease pathways, frevecitinib may address a broader population of patients, including those with non-eosinophilic asthma who remain underserved by current therapies. O'Brien noted that this broad mechanism "may address a broader population of patients and improve outcomes beyond current standards of care."
Phase 1 Clinical Evidence
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 (搜索), and chronic obstructive pulmonary disease (搜索) (COPD). The compound 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.
Unmet Need in Severe Asthma (搜索)
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 (搜索), JAK2 (搜索), JAK3 (搜索), and TYK2 (搜索) currently in clinical development, positioning it uniquely within the respiratory therapeutic landscape.