frevecitinib (KN-002) / Vectura, Kinaset Therap - LARVOL DELTA

Inhaled Frevecitinib Reduces Sputum Eosinophils and Improves FEV1 and ACQ-6 in Subjects With Moderate to Severe Asthma Treated With ICS/LABA (ATS 2025) - P1 | "In addition to previously reported improvements in FeNO, the 10-day administration of frevecitinib to subjects with moderate to severe asthma results in FEV1 and ACQ-6 improvements associated with a reduction in sputum eosinophil levels. These results support further Phase 2 studies of frevecitinib in subjects with uncontrolled asthma using medium to high dose ICS/LABA."

Clinical • Asthma • Immunology • Respiratory Diseases

Kinaset Therapeutics Announces FDA Clearance of IND Application for frevecitinib (KN-002) in Asthma Treatment (Businesswire) - "Kinaset Therapeutics...announced that the United States Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for frevecitinib (KN-002). This novel inhaled dry powder therapeutic is in development for patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies. These patients are typically prescribed medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), with or without additional controllers such as long-acting muscarinic antagonists (LAMA). Kinaset plans to begin a Phase 2b dose ranging trial in mid-2025."

IND • New P2b trial • Asthma

Late Breaking Abstract - The safety and PK of an inhaled pan JAK inhibitor (KN-002) in subjects with COPD (ERS 2024) - P1 | "Inhaled KN-002 was well tolerated by subjects with COPD on background therapy. Outcomes support further evaluation to determine the clinical efficacy of KN-002 in subjects with COPD."

Clinical • Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Hematological Disorders • Immunology • Pain • Respiratory Diseases

Safety and PK of KN-002 in subjects with moderate to severe asthma using ICS/LABA (ERS 2024) - P1 | "Inhaled KN-002 was well tolerated by subjects with moderate to severe asthma using ICS/LABA. Outcomes support the Phase 2 development in subjects with uncontrolled asthma using medium to high dose ICS/LABA treatment."

Clinical • Asthma • Hematological Disorders • Immunology • Otorhinolaryngology • Pain • Respiratory Diseases

KN-002 reduces fractional exhaled nitric oxide in moderate to severe asthma (ERS 2024) - P1 | "KN-002 caused clinically relevant FeNO reduction over 10 days independent of baseline FeNO / blood eosinophils. These results support KN-002 development in eosinophilic and non-eosinophilic moderate to severe asthma."

Asthma • Immunology • Respiratory Diseases

Kinaset Therapeutics to Share Outcomes from the Phase 1 Clinical Evaluation of Frevecitinib (KN-002), an Inhaled Pan JAK Inhibitor, in Patients with Moderate to Severe Asthma and COPD via Oral Presentations and Poster at ERS Congress (Businesswire) - "Kinaset Therapeutics...today announced two oral presentations and a late breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress being held September 7-11, 2024, in Vienna, Austria. The presentations demonstrate the potential of Kinaset’s lead clinical candidate, frevecitinib (KN-002), to treat all patients with moderate to severe asthma and patients with COPD."

Clinical data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - P1 | N=117 | Completed | Sponsor: Kinaset Therapeutics Inc | Active, not recruiting ➔ Completed

Trial completion • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Clinically Relevant Reductions in FeNO Reported After 10-day Treatment With KN-002 in Subjects With Mild Asthma (ATS 2024) - P1 | "Pharmacological engagement was demonstrated by clinically relevant FeNO reductions in subjects with stable mild asthma. Maximal response was observed at a dose (4 mg BID) administered via a single unit-dose capsule. These outcomes supported the further evaluation of a 4 mg BID regimen in subjects with moderate to severe asthma despite use of concomitant ICS/LABA therapy."

Clinical • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Kinaset Therapeutics Debuts Positive Outcomes Data from Phase 1b Study of KN-002 at the 2024 American Thoracic Society (ATS) International Conference (Businesswire) - P1b | N=117 | NCT05006521 | Sponsor: Kinaset Therapeutics Inc | "Kinaset Therapeutics...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."

P1 data • Asthma • Chronic Obstructive Pulmonary Disease

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 (AAAAI 2024) - P1 | "Using an inhaled route of delivery, KN-002 was well tolerated with low systemic exposure and no safety concerns identified following single (≤12 mg) and 10-day repeat dosing (≤8 mg BID) in healthy volunteers and subjects with mild asthma, respectively. Outcomes support the Phase 2 clinical development of KN-002 in subjects with moderate to severe asthma not controlled on ICS/LABA treatment."

Clinical • PK/PD data • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Pulmonary Disease • Respiratory Diseases

Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - P1 | N=117 | Active, not recruiting | Sponsor: Kinaset Therapeutics Inc | Recruiting ➔ Active, not recruiting | Trial completion date: May 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Kinaset Therapeutics to Present KN-002 Phase 1 Clinical Study Outcomes at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting (Businesswire) - "Kinaset Therapeutics...today announced an upcoming oral presentation at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting being held on February 23-26, 2024...will deliver an oral presentation on outcomes from the Phase 1 evaluation of Kinaset’s lead candidate, KN-002, an orally inhaled novel, pan-JAK inhibitor being advanced for the treatment of moderate to severe asthma."

P1 data • Asthma

Kinaset Therapeutics to Present at the American Thoracic Society (ATS) 2023 Respiratory Innovation Summit (Businesswire) - "Kinaset Therapeutics...today announced an upcoming presentation at the ATS 2023 Respiratory Innovation Summit being held in Washington D.C. May 19-20, 2023. Robert Clarke, PhD, Chief Executive Officer of Kinaset, will deliver an oral and poster presentation on the latest clinical progress of Kinaset’s lead candidate, KN-002, a novel, pan-JAK inhibitor being advanced for the treatment of moderate to severe asthma."

Clinical • Immunology • Inflammation

Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - P1 | N=128 | Recruiting | Sponsor: Kinaset Therapeutics Inc | N=80 ➔ 128 | Trial completion date: May 2022 ➔ May 2023 | Trial primary completion date: Feb 2022 ➔ Apr 2023

Enrollment change • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] The pan janus kinase (JAK) inhibitor KN-002 suppresses inflammatory mediator release from severe asthma bronchial epithelial cells. (ERS 2021) - "KN-002 is a potent and broad inhibitor of IL-13- and IFNγ+TNFα-induced inflammation implicated in the pathogenesis of Th2-high and Th2-low asthma ex vivo. The data support a potential therapeutic role in severe asthma and COPD."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CSF2 • CXCL1 • CXCL10 • CXCL8 • IFNG • IL13 • IL17A • IL6 • STAT3 • STAT5 • STAT6 • TNFA

Single and Multiple Ascending Dose Study of KN-002 (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Kinaset Therapeutics Inc

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Kinaset Therapeutics Launches with a $40M Series A Financing to Develop Novel Therapeutics for Respiratory Diseases and an Exclusive Global License Agreement with Vectura Group for KN-002 (VR588), a Novel Anti-Inflammatory (Businesswire) - "Kinaset...today announced a $40 million Series A financing with a blue-chip investor syndicate of 5AM Ventures, Atlas Venture, and Gimv. The Company also announced an exclusive global in-license and services agreement with Vectura Group plc (LSE: VEC) ('Vectura') to develop and commercialize KN-002 (formerly known as VR588), a novel, inhaled small-molecule pan-JAK inhibitor, for the treatment of eosinophilic and non-eosinophilic severe asthma. A Phase 1/1b clinical trial in healthy volunteers and patients is poised to begin in the first half of 2021."

Licensing / partnership • New P1 trial • Asthma • Respiratory Diseases

In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma (clinicaltrials.gov) - P; N=10; Completed; Sponsor: Imperial College London; Recruiting ➔ Completed

Trial completion

In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma (clinicaltrials.gov) - P0; N=9; Recruiting; Sponsor: Imperial College London

New trial