camlipixant (GSK5464714) / AstraZeneca, GSK - LARVOL DELTA

Camlipixant Reduces Burden of Cough-related Urinary Incontinence in Patients With Refractory Chronic Cough in Post-hoc Analysis of A Phase 2b Trial (ATS 2024) - P2b | "A general, validated UI scale was useful for assessing changes in cough-related UI in patients with RCC; however, use of the ICIQ-SF in the assessment of cough-related UI warrants further study. Treatment of cough with camlipixant may be associated with a reduction in the burden of cough-related UI in patients with RCC."

Clinical • P2b data • Retrospective data • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases • Urinary Incontinence • Urology

A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bellus Health Inc. - a GSK company | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2024 ➔ Jul 2024

Enrollment open • Trial primary completion date • Cough • Hepatology • Respiratory Diseases

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Bellus Health Inc. - a GSK company | Active, not recruiting ➔ Recruiting

Enrollment open • Cough • Respiratory Diseases

Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bellus Health Inc. - a GSK company | Not yet recruiting ➔ Completed

Trial completion

Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bellus Health Inc. - a GSK company | Not yet recruiting ➔ Completed

Trial completion

Camlipixant: Acceptance of regulatory submissions in US/EU for refractory chronic cough (based on CALM-1 and CALM-2 trials) in 2025 (GSK) - Q4 & FY2023 Results

European regulatory • NDA • Chronic Cough

A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Cough • Hepatology • Respiratory Diseases

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2) (clinicaltrials.gov) - P3 | N=825 | Recruiting | Sponsor: Bellus Health Inc. - a GSK company | Trial completion date: Jul 2025 ➔ Jun 2026

Trial completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

CALM-1: A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (clinicaltrials.gov) - P3 | N=825 | Recruiting | Sponsor: Bellus Health Inc. - a GSK company | Trial completion date: Jul 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Bellus Health Inc. - a GSK company

New P1 trial

Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Bellus Health Inc. - a GSK company | Recruiting ➔ Active, not recruiting | N=16 ➔ 32 | Trial completion date: Mar 2023 ➔ May 2024 | Trial primary completion date: Feb 2023 ➔ May 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Camlipixant: Data from P3 CALM-1 trial (NCT05599191) for refractory chronic cough in H2 2025 (GSK) - Getting ahead of Respiratory Diseases with GSK management: Data from P3 CALM-2 trial (NCT05600777) for refractory chronic cough in H2 2025

P3 data • Chronic Cough

Improvements in Leicester Cough Questionnaire Subdomains in a Phase 2b Trial of Camlipixant in Refractory Chronic Cough (ERS 2023) - P2b | "Improvements in cough-related quality of life over 29 days of treatment with camlipixant in SOOTHE were supported by consistent improvements in all three LCQ subdomains.; Epidemiology; Public health; Pulmonary rehabilitation; Cell and molecular biology; General respiratory patient care; Physiology; Imaging"

P2b data • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Prevalence And Characterization of Cough-Related Urinary Incontinence in A Refractory Chronic Cough Population Enrolled in A Phase 2b Trial of The P2X3 Antagonist, Camlipixant (ERS 2023) - "To our knowledge, this is the first report of cough-related UI assessed by direct vs indirect solicitation in the same RCC population. These results suggest that the actual burden of urinary incontinence in patients with RCC may often be overlooked by routine medical history. Instead, direct query by physicians may provide a more accurate assessment of UI in these patients.; Physiology; General respiratory patient care; Public health; Pulmonary function testing; Cell and molecular biology; Epidemiology"

Clinical • P2b data • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases • Urinary Incontinence • Urology

Abstracts from the 2023 American Cough Conference. (PubMed, Lung) - No abstract available

Journal • Cough • Immunology • Respiratory Diseases

Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Bellus Health Inc

New P1 trial

"GSK concludes acquisition of BELLUS Health @GSK #GSK #GSKnews #BELLUSHealth #acquisition #camlipixant https://t.co/uEaZAOBaI7" (@medicaldialogs)

GSK completes acquisition of BELLUS Health (GSK Press Release) - "GSK plc...and BELLUS Health...announced GSK has completed the acquisition of BELLUS, a biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC), by way of a plan of arrangement in accordance with Section 192 of the Canada Business Corporations Act (the 'Arrangement'). The Arrangement was approved by BELLUS’ shareholders on 16 June 2023. As previously announced, the acquisition of BELLUS includes camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC."

M&A • Chronic Cough • Cough • Respiratory Diseases

Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Bellus Health Inc

New P1 trial

Model-based Dose Selection for Phase 3 Trials of the Selective P2X3 Antagonist Camlipixant in Refractory Chronic Cough (ATS 2023) - P1, P2, P2b | "The selective P2X3 antagonist camlipixant (BLU-5937) has been studied in refractory chronic cough (RCC) in two phase 2 clinical trials... In the absence of dose-related safety findings, based on population pharmacokinetic E-R analysis, the 25 and 50 mg BID doses were predicted to achieve efficacy (>90% of maximum effect) in cough frequency reduction. Thus, these doses were deemed to be the most appropriate to study in phase 3 pivotal trials of camlipixant in RCC."

P3 data • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Response in Patient-reported Cough Severity in Soothe, a Phase 2b Trial of Camlipixant in Refractory Chronic Cough (ATS 2023) - "Here we report the responder rates in CS-VAS observed in SOOTHE, a phase 2b, dose-finding trial of camlipixant (BLU-5937) for the treatment of refractory chronic cough... More patients experienced meaningful improvements in patient-reported cough severity over 29 days of treatment with camlipixant than with placebo."

Clinical • P2b data • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Camlipixant: Topline data from P3 CALM-1 trial (NCT05599191) for refractory chronic cough in H2 2024 (BELLUS Health) - Corporate Presentation: Topline data from P3 CALM-2 trial (NCT05600777) for refractory chronic cough in 2025

P3 data: top line • Chronic Cough

P2X3 Potentiates IgE Mediated Mast Cell Function (P515) (IMMUNOLOGY 2023) - "Prior data from our lab testing the effects of fluoxetine on IgE-driven mast cell function indicated a role for the purinergic receptor P2X3...The P2X3 inhibitors BLU-5937 and Gefapixant administered intraperitoneally suppressed cytokine levels measured in the plasma of mice subjected to the mast cell-dependent passive systemic anaphylaxis model (PSA). Furthermore, P2X3 knock-out mice showed reduced IL-6 compared to wild-type mice in the PSA model. Interestingly, inhibition or deletion of the P2X3 receptor showed no effect on mast cell degranulation in vitro and did not reduce hypothermia during PSA. We propose that an ATP-P2X3 autocrine or paracrine loop augments mast cell-mediated inflammation, thus offering a potential new target for the treatment of allergic disease."

Allergy • Immunology • Inflammation • Pain • IL6

BELLUS Health Reports First Quarter 2023 Financial Results and Business Highlights (Businesswire) - "The Company will be presenting an oral abstract entitled 'Response in Patient-reported Cough Severity in SOOTHE, a Phase 2b Trial of Camlipixant in Refractory Chronic Cough' on Sunday, May 21, 2023 at 3:15-3:27 p.m. ET, and a poster presentation entitled 'Model-based Dose Selection for Phase 3 Trials of the Selective P2X3 Antagonist Camlipixant in Refractory Chronic Cough' will be presented on Monday, May 22, 2023 at 11:30-1:15 p.m. ET....Research and development expenses, net of research tax credits, amounted to US$22.3 million for the quarter ended March 31, 2023, compared to US$11.3 million for the same period in 2022, a US$11.0 million or 98% year over year increase."

Commercial • P2b data • Chronic Cough • Cough

GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health (Businesswire) - "GSK plc...today announced that they have entered into an agreement under which GSK will acquire BELLUS, a Canada-based, late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity value of US$2.0 billion (£1.6 billion). The acquisition provides GSK access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC....Following the anticipated regulatory approval and launch of camlipixant in 2026, the acquisition is expected to be accretive to adjusted EPS from 2027 and has the potential to deliver significant sales through 2031 and beyond."

Launch • M&A • Regulatory • Chronic Cough • Cough