Verona COPD trial, ENHANCE-2 for ensifentrine, completes recruitment

Verona Pharma has completed patient enrollment for ENHANCE-2, a Phase 3 clinical trial evaluating the safety and efficacy of ensifentrine, an inhaled treatment for chronic obstructive pulmonary disease (COPD).

According to Verona, the trial exceeded its enrollment goal of 800 participants, even amid the COVID-19 pandemic. The first data is expected later this year.

“The completion of enrollment for the Phase 3 ENHANCE-2 trial with over 800 subjects is a significant achievement for Verona Pharma,” said David Zaccardelli, President and CEO of Verona, in a press release. “We are pleased to have achieved our recruiting goals during the ongoing global pandemic.”

In September 2020, Verona launched the ENHANCE Phase 3 program, which included two trials: ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057).

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The two studies, ongoing at clinical sites in Europe and the United States, were designed to evaluate the safety and efficacy of a nebulized suspension of ensifentrine as maintenance therapy for patients with moderate COPD. to severe.

In these trials, ensifentrine is given alone or in addition to a bronchodilator – either a long-acting muscarinic antagonist (LAMA) or a long-acting beta-agonist (LABA). It should be noted that bronchodilators are drugs that help relax the muscles surrounding the airways of the lungs, widening them and facilitating airflow through the lungs.

Participants are randomly selected to receive either a nebulized suspension containing 3 mg of ensifentrine or a placebo, given twice daily. ENHANCE-2 lasts for 24 weeks, or just under six months, while patients in ENHANCE-1 receive treatment or placebo for 24 or 48 weeks.

Registration for the 48-week group of ENHANCE-1 was completed late last year, with approximately 400 participants. For the 24-week group, registration should be complete by June.

The primary objective of the studies is to evaluate the ability of ensifentrine to stimulate lung function in patients, as measured by changes in forced expiratory volume in one second (FEV1) more than 12 hours of drug exposure after 12 weeks (about three months) of treatment.

Secondary objectives include evaluating the ability of therapy to reduce symptom severity and improve patients’ health-related quality of life. Safety measures will also be assessed on the shorter (24 weeks) and longer (48 weeks) regimens.

If the results are positive, Verona said it intends to file a New Drug Application with the U.S. Food and Drug Administration by June 2023, seeking approval of ensifentrine for the COPD treatment.

“We expect to report key data from ENHANCE-2 in the third quarter of 2022 and ENHANCE-1 towards the end of 2022. We look forward to communicating these results and working with regulators to address the urgent need of a new treatment for COPD,” said Zaccardelli.

Ensifentrine is a dual inhibitor of two phosphodiesterase (PDE) enzymes – PDE3 and PDE4 – involved in muscle contraction and inflammation of the airways. The therapy is designed to block the action of these enzymes, which means that ensifentrine acts as a bronchodilator, making it easier for air to enter the lungs. It also acts as an anti-inflammatory agent.

Earlier results from a phase 2b trial (NCT03937479) showed that ensifentrine plus maintenance tiotropium – an LAMA marketed as Spiriva Respimat by Boehringer Ingelheim – significantly improved lung function and the quality of life of COPD patients with impaired lung function and disease symptoms.

Verona is also developing a pressurized metered dose inhaler to deliver ensifentrine. Previous data from a phase 2 trial (NCT04091360) support its potential benefits for patients with moderate to severe COPD.

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