16 September 2021 - - The first 24 participants have been dosed in US-based biopharmaceutical company Kinaset Therapeutics' Phase 1b placebo-controlled study, the company said.

This trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KN-002, a novel and potent inhibitor of all Janus kinase isoforms (i.e. JAK1, JAK2, JAK3, TYK2) that is formulated as a dry powder for inhaled delivery to the lung.

The KN-002 Phase 1b trial is being conducted in the United Kingdom at the Medicines Evaluation Unit under the guidance of Professor David Singh.

The study comprises two separate parts: Part 1 will evaluate the safety, tolerability and PK of single ascending doses in up to 48 healthy volunteers; Part 2 involves the safety, tolerability, PK and PD assessment of multiple ascending doses in up to 32 patients with stable asthma who are naïve to inhaled corticosteroid therapy.

Changes in fractional exhaled nitric oxide levels, from baseline to the end of treatment, will be the key Part 2 PD endpoint.

Asthma is a complex and heterogeneous disease affecting over 300 m people worldwide, with approximately 10% of patients having severe asthma.

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.

Multiple inflammatory pathways are implicated in the pathogenesis of asthma; patients with eosinophilic mediated disease, typically characterized by elevated levels of blood eosinophils, 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.

KN-002 is a potent and balanced inhibitor of all JAK isoforms (i.e., JAK1, JAK2, JAK3 and TYK2)8 under development as a non-invasive anti-inflammatory treatment for all patients with severe asthma plus other respiratory conditions such as 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 while minimizing systemic exposure levels. KN-002 was licensed from Vectura Ltd. in 2020.

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 and non-invasive anti-inflammatory to treat all patients with severe asthma.

With founding investors 5AM Ventures, Atlas Venture and Gimv, the company is pursuing a patient-focused approach to build a leading respiratory therapeutics company.