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

PANAIRAMA: A Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma (clinicaltrials.gov) - P2 | N=512 | Recruiting | Sponsor: Kinaset Therapeutics Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Kinaset Therapeutics Announces First Patient Dosed in Phase 2b PANAIRAMA Trial of frevecitinib (KN-002) in Patients with Severe Asthma (Businesswire) - "PANAIRAMA is a randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate the efficacy, safety and pharmacokinetics of three doses of frevecitinib. The study is intended to identify the optimal dose regimen to support future pivotal clinical development. The trial will enroll patients across multiple clinical sites in the United States and internationally."

Trial status • Asthma

PANAIRAMA: A Phase 2 Dose Ranging Clinical Study to Evaluate the Efficacy and Safety of Frevecitinib (KN-002) in Patients With Severe Asthma (clinicaltrials.gov) - P2 | N=512 | Not yet recruiting | Sponsor: Kinaset Therapeutics Inc

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Kinaset Therapeutics Announces $103 Million Oversubscribed Series B Financing to Advance Novel, Inhaled Therapeutic Candidate for Respiratory Diseases (Businesswire) - "Financing round led by RA Capital Management and Forge Life Science Partners, with contributions from new and existing investors; Proceeds to advance frevecitinib, an inhaled pan-JAK inhibitor with the potential to treat the broad severe asthma population, through Phase 2 studies."

Financing • Asthma

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