Ensifentrine Clinical Trials in China OK’d, Nuance Announces

The therapy is being tested in the ENHANCE program by developer Verona Pharma

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by Steve Bryson, PhD |

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Nuance Pharma has been given the go-ahead to launch clinical trials in China to evaluate the investigational therapy ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

The company asked permission, in the form of an investigational new drug (IND) application, to conduct both Phase 1 and Phase 3 studies. While the Phase 1 study would assess the medication’s pharmacological properties in healthy volunteers, the Phase 3 trial would assess its safety and effectiveness in patients with moderate to severe COPD over a period of 24 weeks (nearly six months).

“We are thrilled to introduce this first-in-class molecule to China and give our Chinese investigators and subjects the opportunity to participate in the global clinical development of this novel molecule and to evaluate how to apply it to Chinese COPD clinical setting properly,” Haijin Meng, Nuance’s chief medical officer, said in a press release.

Nuance entered into an agreement with Verona Pharma, ensifentrine’s developer, to advance and commercialize the therapy in China, Hong Kong, Macau, and Taiwan.

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“We are pleased our development partner, Nuance Pharma, has received IND approval to begin pivotal studies in COPD with ensifentrine in mainland China,” David Zaccardelli, Verona’s president and CEO, said in another press release.

Ensifentrine is a first-in-class therapy designed to suppress the activity of two enzymes, phosphodiesterase 3 and 4 (PDE3 and PDE4), that are involved in muscle contraction and airway inflammation. As a result, it’s expected to help reduce inflammation and act as a bronchodilator, a substance that widens the airways.

Ensifentrine is being tested in the Verona-sponsored ENHANCE program, which includes two Phase 3 clinical trials: ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057).

Underway at sites in Europe and the U.S., both studies are investigating the effectiveness and safety of a nebulized suspension of ensifentrine as a maintenance therapy for adults with moderate to severe COPD. It’s being evaluated alone or as an add-on therapy to a bronchodilator — either a long-acting beta-agonist (LABA) or a long-acting muscarinic antagonist (LAMA).

Participants were randomly assigned to receive either a suspension containing 3 mg of ensifentrine, or a placebo, twice daily. ENHANCE-2 is a 24-week study, lasting just less than six months, while in ENHANCE-1, patients will receive the therapy or placebo for either 24 or 48 weeks (nearly a year).

The primary goal of both studies is to assess ensifentrine’s impact on lung function as measured by forced expiratory volume in one second (FEV1), which measures the total amount of air a person can forcibly exhale in a second, over 12 hours of exposure after 12 weeks (about three months).

Secondary outcomes include changes in symptom severity and health-related quality of life. Safety will be examined over the shorter (24 weeks) and longer (48 weeks) regimens.

ENHANCE-1 enrollment was completed in June, five months after ENHANCE-2 completed its enrollment, with both studies including more than 800 participants each.

In newly released top-line data, ENHANCE-2 met both primary and secondary endpoints, showing that ensifentrine improved lung function and significantly lowered the rate and risk of COPD exacerbations, or sudden symptom worsening.

“This is an important milestone and, based on our recent positive Phase 3 results from our ENHANCE-2 trial in COPD, we remain confident about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD,” Zaccardelli said.

Verona expects to report top-line data from ENHANCE-1 around the end of the year. If findings are similar to those of ENHANCE-2, the company plans to submit an application to U.S. Food and Drug Administration requesting ensifentrine’s approval in early 2023.