ensifentrine/glycopyrrolate (MK-5884A) / Merck (MSD) - LARVOL DELTA

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=497 | Completed | Sponsor: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA | Active, not recruiting ➔ Completed | N=1119 ➔ 497

Enrollment change • Monotherapy • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=1119 | Active, not recruiting | Sponsor: Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA | Recruiting ➔ Active, not recruiting | N=480 ➔ 1119

Enrollment change • Enrollment closed • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Verona Pharma plc | Trial completion date: Apr 2026 ➔ Jul 2026 | Trial primary completion date: Apr 2026 ➔ Jul 2026

Monotherapy • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=33 | Completed | Sponsor: Verona Pharma plc | Active, not recruiting ➔ Completed

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

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Verona Pharma plc | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Verona Pharma plc | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Enrolling by invitation | Sponsor: Verona Pharma plc | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Verona Pharma plc | Enrolling by invitation ➔ Recruiting

Enrollment status • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Verona Pharma plc

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Not yet recruiting | Sponsor: Verona Pharma plc

Monotherapy • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Verona Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "In the second half of 2025, the Company plans to start a dose-ranging Phase 2b trial to assess the safety and efficacy of a fixed-dose nebulized combination of ensifentrine with glycopyrrolate...In 2025, the Company plans to progress the regulatory activities for potential marketing authorization application submissions for Ohtuvayre for the maintenance treatment of COPD in the European Union and in the UK. In mid-2025, the Company’s development partner in Greater China, Nuance Pharma, is expected to report results from its pivotal Phase 3 trial evaluating ensifentrine for the maintenance treatment of COPD in China."

Approval • P2b data • P3 data • Chronic Obstructive Pulmonary Disease • Pulmonary Disease • Respiratory Diseases

Verona Pharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "In July 2024, the Company submitted an investigational new drug application ('IND') to the FDA to allow initiation of the clinical program for development of a fixed-dose combination of ensifentrine and glycopyrrolate...Subject to clearance of the IND, the Company intends to initiate a Phase 2 dose-ranging trial in the third quarter of 2024. Also in the third quarter of 2024, the Company plans to initiate a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis ('NCFBE'). In the second half of 2024, the Company plans to present further analyses from the Phase 3 ENHANCE trials at the European Respiratory Society International Congress 2024 and at CHEST Annual Meeting 2024."

IND • New P2 trial • P3 data • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Immunology • Non‐Cystic Fibrosis Bronchiectasis

Verona Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "The FDA has assigned a PDUFA target action date of June 26, 2024 and notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application. If approved, the Company intends to launch ensifentrine in the US market in the second half of 2024...the Company plans to submit an investigational new drug application ('IND') to the FDA and, subject to clearance, initiate a Phase 2 clinical trial assessing the safety and efficacy of the fixed-dose combination formulation in COPD patients....In the second half of 2024, the Company plans to commence a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with NCFBE, subject to clearance by the FDA....Research and development ('R&D') expenses were $4.1 million for the fourth quarter ended December 31, 2023 (Q4 2022: $6.8 million)....the Company was incurring costs with the then ongoing Phase 3 ENHANCE program."

IND • Launch US • New P2 trial • PDUFA date • Chronic Obstructive Pulmonary Disease • Non‐Cystic Fibrosis Bronchiectasis

Verona Pharma Reports Third Quarter 2023 Financial Results and Provides Corporate Update (Verona Pharma Press Release) - "The Company is developing a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist ('LAMA'), for the maintenance treatment of patients with COPD via delivery in a nebulizer. If a feasible formulation is developed, in the second half of 2024, the Company plans to submit an investigational new drug ('IND') application to the FDA and, if cleared, initiate a Phase 2 clinical trial assessing the safety and efficacy of the fixed-dose combination formulation in COPD patients....Also in the second half of 2024, if the FDA approves the Company’s NDA for ensifentrine as a maintenance treatment of COPD, the Company plans to commence a Phase 2 clinical trial to assess the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis, subject to clearance by the FDA."

IND • New P2 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases