Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Verona Pharma said that the first part of a two-part phase 2 trial of ensifentrine in a dry powder inhaler (DPI) formulation for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD) has yielded positive interim efficacy and safety data.
Image: Verona reports positive interim data for ensifentrine DPI formulation in phase 2 trial. Photo: courtesy of Photokanok/FreeDigitalPhotos.net.
Subscribe to our email newsletter
Also known as RPL554, ensifentrine, is being investigated as an inhaled dual inhibitor of the phosphodiesterase 3 and 4 enzymes and is designed to have bronchodilator and anti-inflammatory properties.
The first part of the phase 2 trial saw the enrolled 37 patients subjected to a single dose of one of the five dosage strengths of ensifentrine or placebo.
Compared to placebo, patients treated with the investigational drug showed statistically significant and clinically meaningful increase in their lung function as measured by forced expiratory volume in one second (FEV1), as per the interim efficacy and safety data from the single dose study.
The DPI formulation of the Verona drug candidate has been shown to be well tolerated at each dose with an adverse event profile that was identical to placebo.
Verona said that the positive results from the first part of the mid-stage trial support initiation of the other part to evaluate the DPI formulation of the investigational drug administered twice a day for a week to patients with moderate-to-severe COPD.
Verona CEO Jan-Anders Karlsson said: “The large bronchodilator response, 12-hour duration of action and good tolerability observed with the DPI ensifentrine formulation in the first portion of this study are very encouraging and we look forward to proceeding with the second part to evaluate treatment over a one-week period.
“Positive data from this and future studies with inhaler formulations could dramatically expand the clinical utility and commercial opportunity for ensifentrine not only in the treatment of COPD, but potentially in other respiratory diseases such as asthma.”
The second part of the phase 2 trial is a randomized, double-blind, placebo-controlled, multiple dose crossover study, held at one site in the US. Enrolled patients will be randomized to one of four dose levels of 150 µg, 500 µg, 1500 µg, or 3000 µg of the investigational respiratory drug or placebo.
Verona said that it is also working on advancing the nebulized formulation of ensifentrine through phase 2b clinical development. The company is also looking to initiate a phase 2 trial of a pressurised metered-dose inhaler (pMDI) formulation of the drug candidate in COPD patients in the second quarter of 2019.
