Kinaset Therapeutics Debuts Positive Outcomes Data from Phase 1b Study of KN-002 at the 2024 American Thoracic Society (ATS) International Conference
21 Mayo 2024 - 11:15AM
Business Wire
– Once- and twice-daily administration of
KN-002 achieved clinically relevant reductions in fractional
exhaled nitric oxide (FeNO) levels without safety concerns –
– Outcomes support evaluation of KN-002 in
patients with eosinophilic and non-eosinophilic moderate to severe
asthma and chronic obstructive pulmonary disease (COPD) –
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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Company Contact Roger Heerman – Chief Business Officer
info@kinasettx.com +1 508-858-5810
Media Contact MacDougall Lauren Arnold
larnold@macdougall.bio +1 (617) 694-5387