Kinaset Therapeutics Presents Positive Phase 1b KN-002 Data at 2024 ATS Conference

Kinaset Therapeutics, a biopharmaceutical company in the clinical stage, has released promising results from Part 2 of their multi-part Phase 1b study on the pan-JAK inhibitor KN-002. This study, which looked at the safety, tolerability, pharmacokinetics, and pharmacodynamics of KN-002, will be presented at the 2024 American Thoracic Society (ATS) International Conference.

The study was structured as a randomized, double-blind, placebo-controlled trial and involved subjects with mild asthma who had not previously been treated with inhaled corticosteroids. Over a period of 10 days, subjects received daily doses of up to 16 mg of KN-002. The outcomes were positive, showing no safety or tolerability issues associated with the drug. Additionally, administration of KN-002 once or twice daily led to significant and rapid reductions in fractional exhaled nitric oxide (FeNO) levels, an important marker of airway inflammation, when delivered via a single capsule. Pharmacokinetic data indicated that plasma concentrations of the drug were dose-proportional but remained below levels deemed pharmacologically active.

Robert Clarke, PhD, CEO of Kinaset, expressed optimism about the findings, noting that they support further development of KN-002 as a potential treatment for asthma. The company plans to launch a Phase 2 clinical trial to evaluate the efficacy of once- and twice-daily doses of KN-002 in patients with both eosinophilic and non-eosinophilic asthma who have not responded adequately to medium- to high-dose inhaled corticosteroids combined with long-acting beta2 agonists.

The Phase 1b study was conducted in the UK at the Medicines Evaluation Unit under the supervision of Professor Dave Singh. It comprised four parts:
1. A single ascending dose (SAD) study in healthy volunteers
2. A multiple ascending dose (MAD) study in subjects with mild asthma
3. A repeat dose study in patients with moderate to severe asthma maintained on ICS/LABA
4. A repeat dose study in patients with COPD treated with ICS, LABA, and/or long-acting muscarinic antagonist (LAMA) background treatments.

Asthma is a multifaceted disease affecting over 300 million individuals worldwide, with about 10% experiencing severe forms of the condition. These patients endure reduced lung function, frequent exacerbations, and a lowered quality of life, contributing significantly to healthcare costs. Various inflammatory pathways are involved in asthma's pathogenesis. While patients with eosinophilic asthma have benefited from new biological treatments, those with non-eosinophilic asthma still face a lack of effective therapies.

KN-002 is designed as a dry powder for inhalation, offering a non-invasive anti-inflammatory treatment for both eosinophilic and non-eosinophilic asthma, as well as COPD. Its formulation aims to deliver the drug efficiently to the lungs while minimizing systemic exposure. KN-002, which inhibits all JAK isoforms (JAK1, JAK2, JAK3, and TYK2), was licensed from Vectura Ltd. in 2020.

Kinaset Therapeutics focuses on developing inhaled treatments for serious respiratory conditions. Their leading candidate, KN-002, is currently undergoing Phase 1b trials involving patients with varying severities of asthma and COPD. The company is backed by investors such as 5AM Ventures, Atlas Venture, and Gimv, and aims to become a leader in respiratory therapeutics.