Verona Pharma Initiates Multiple Dose Part of Phase 2 Clinical Trial with pMDI Formulation of Ensifentrine in COPD
LONDON and RALEIGH, N.C., August 19, 2020 – Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces the initiation of the second, multiple dose, part of a Phase 2 trial to evaluate the pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”). Results from the study (Part B) are expected in the first half of 2021.
Positive efficacy and safety data from the first, single dose, part of the study (Part A) in 40 patients with moderate to severe COPD were announced by the Company on March 31, 2020. The results demonstrated a statistically significant and clinically meaningful increase in lung function as measured by forced expiratory volume in one second (“FEV1”)1 compared to placebo. Verona Pharma decided to postpone initiation of Part B of the study due to concerns for the safety of patients and study staff because of the COVID-19 pandemic. Following an assessment of local infection rates and control measures in addition to procedures put in place by the UK clinical sites, the Company has now initiated Part B, which will evaluate the pMDI formulation.
Multiple Dose Crossover Trial, Part B
· Patient Population: Approximately 30 moderate to severe COPD patients who participated in Part A are planned to continue to Part B at two sites in the UK.
· Dose/Duration: Patients will be randomized to receive 3 dose levels (300 µg, 1000 µg, 3000 µg) of pMDI ensifentrine or placebo, twice-daily over one week. All patients will receive each of the dose levels and placebo over four 7-day treatment periods.
· Primary Endpoint: Improvement in lung function as measured by peak FEV1 with ensifentrine compared to placebo after 7 days of treatment.
· Secondary Endpoints: Safety and tolerability, other lung function measures such as trough FEV1, average FEV1 over 4 and 12 hours, and steady state pharmacokinetic profile of ensifentrine pMDI.
“We are pleased to start the multiple dose part of this pMDI study and expect the results in the first half of 2021,” said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. “Data from the single dose part of this pMDI study are very encouraging and consistent with data from Phase 2 clinical trials with our nebulized and dry powder inhaler (“DPI”) formulations of ensifentrine.
pMDI and DPI formulations are important delivery mechanisms in the approximately $9.6 billion US market for maintenance COPD therapies2. The development of pMDI and DPI formulations of ensifentrine provides expanded opportunities including life cycle management, new indications and partnering. We look forward to providing further updates on this pMDI study and our upcoming Phase 3 ENHANCE trials and pilot trial in hospitalized patients with COVID-19.”
For further information on this clinical trial, please visit ClinicalTrials.gov, NCT04091360.
1 FEV1: Forced Expiratory Volume in one second, a standard measure of lung function
2 IQVIA MIDAS, IQVIA MIDAS Medical
Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine has demonstrated significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness, in Verona Pharma’s prior Phase 2 clinical studies in patients with moderate to severe COPD. In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people to date.
About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. Following a response from the U.S. FDA to Verona Pharma’s End-of-Phase 2 briefing package, the Company plans to initiate its Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) later in 2020 for nebulized ensifentrine for COPD maintenance treatment. The Company raised gross proceeds of $200 million through a private placement in July 2020 and expects the funds to support its operations and Phase 3 clinical program into 2023. Verona Pharma is currently in Phase 2 development with two additional formulations of ensifentrine for the treatment of COPD: dry powder inhaler (DPI) and pressurized metered-dose inhaler. Ensifentrine also has potential applications in COVID-19, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.
- Verona Pharma plc
- Verona Pharma plc