BOSTON--(BUSINESS WIRE)-- Kinaset Therapeutics, a clinical-stage biopharmaceutical company developing inhaled therapeutics to treat serious respiratory diseases, today announced positive outcomes from Part 2 of a multi-part Phase 1b study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of its orally inhaled pan-JAK inhibitor KN-002. The data will be presented at the 2024 American Thoracic Society (ATS) International Conference.

This randomized, double-blind, placebo-controlled study reported no safety or tolerability concerns after the 10-day administration of daily doses ≤16 mg in subjects with mild asthma who were naïve to inhaled corticosteroid therapy. Additionally, the once- and twice-daily administration of KN-002 resulted in rapid and clinically relevant reductions in fractional exhaled nitric oxide (FeNO) levels at doses delivered via a single capsule. Plasma pharmacokinetics were dose proportional with concentrations below pharmacologically active levels.

“We are very encouraged by the outcomes from this Phase 1b study which support the continued development of KN-002 as a future treatment for asthma,” said Robert Clarke, PhD, Chief Executive Officer of Kinaset. “We look forward to initiating a Phase 2 dose-ranging clinical study designed to evaluate the clinical efficacy of once- and twice-daily regimens of KN-002 in patients with eosinophilic and non-eosinophilic asthma inadequately controlled with medium- to high-dose inhaled corticosteroid (ICS)/long-acting beta₂ agonist (LABA) maintenance treatment.”

Presentation Details:
Title: Clinically Relevant Reductions in FeNO Reported After 10-day Treatment With KN-002 in Subjects With Mild Asthma
Session Title: What’s New in Clinical Asthma
Session Date and Time: Tuesday, May 21 at 9:15 a.m. - 4:15 p.m. PT
Location: San Diego Convention Center in San Diego, CA

Trial Design and Execution (ClinicalTrials.gov Identifier: NCT05006521)
The KN-002 Phase 1b trial is being conducted in the United Kingdom at the Medicines Evaluation Unit (MEU) under the guidance of Professor Dave Singh. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers. Results from the Part 1 SAD study in healthy volunteers were recently presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.¹ Part 2 is a multiple ascending dose (MAD) study (10-day treatment period) in subjects with stable, mild asthma; Part 3 is a repeat dose study (10-day treatment period) in patients with moderate to severe asthma maintained on ICS/LABA and Part 4 is a repeat dose study (10-day treatment period) in patients with COPD treated with ICS, LABA, and/or long-acting muscarinic antagonist (LAMA) background treatments. A more detailed study design overview can be viewed here.

About Asthma
Asthma is a complex and heterogeneous disease affecting over 300 million people worldwide, with approximately 10% of patients having severe asthma.^2,3 This population suffers from compromised lung function, frequent exacerbations, reduced quality of life and is associated with a disproportionate number of asthma-related hospitalizations that account for approximately 50% of asthma-related costs.^2-5 Multiple inflammatory pathways are implicated in the pathogenesis of asthma;^6-8 patients with eosinophilic mediated disease, typically characterized by elevated levels of blood eosinophils,⁸ have benefited from the introduction of parenteral biological therapies whereas those with a non-eosinophilic form continue to suffer from limited availability of safe and effective therapies.

About KN-002
KN-002 is a potent and balanced inhibitor of all JAK isoforms (i.e., JAK1, JAK2, JAK3 and TYK2)⁹ under development as a non-invasive anti-inflammatory treatment for all patients with eosinophilic and non-eosinophilic asthma inadequately controlled with medium- to high-dose ICS/LABA maintenance treatment plus those with COPD. KN-002 is formulated as a dry powder that has demonstrated excellent delivery efficiency and chemical/physical stability. Topical delivery via inhalation is designed to achieve therapeutic drug concentrations at the site of inflammation in the lung whilst minimizing systemic exposure levels. KN-002 was licensed from Vectura Ltd. in 2020.

About Kinaset Therapeutics, Inc.
Kinaset Therapeutics is focused on developing inhaled therapeutics to address significant unmet medical needs in respiratory diseases. The Company’s lead clinical candidate KN-002 is a novel, pan-JAK inhibitor formulated as a dry powder for delivery via the non-invasive oral inhaled route of administration. KN-002 is currently being evaluated in a Phase 1b clinical study involving patients with mild to severe asthma and those with COPD (NCT05006521). With founding investors 5AM Ventures, Atlas Venture and Gimv, the Company is pursuing a patient-focused approach to build a leading respiratory therapeutics company. See more information at the Company’s website.

References:
1. O’Brien C, Morgan F, Wood N, et al. (2024) Safety and Pharmacokinetics of Single Ascending Doses of KN-002 in Healthy Volunteers and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma. The Journal of Allergy and Clinical Immunology https://doi.org/10.1016/j.jaci.2023.11.470
2. Kupczyk M, Wenzel S. J Intern Med 2012;272:121–32.
3. Wenzel S. Am J Respir Crit Care Med. 2005; 172; 149–60.
4. Chung KF, Wenzel SE, Brozek JL, et al. Eur Respir J 2014; 43: 343–73.
5. Price D, Fletcher M, van der Molen T. NPJ Prim Care Respir Med 2014; 12; 24: 14009.
6. Godar M, Blanchetot C, de Haard H, et al. MAbs. 2018; 10 (1): 34–45.
7. Peters MC, Mekonnen ZK, Yuan S, et al. J Allergy Clin Immunol. 2014; 133: 388–94.
8. Fahy JV. Nat Rev Immunol. 2015; 15: 57-65.
9. Wiegman C et al., In-vitro evaluation of a new potent, selective pan Janus kinase (JAK) inhibitor VR588. ERJ 2015; 46: PA2130.

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