Chalk up a much-needed — if preliminary — win for Verona Pharma in its multi-pronged effort to tackle COPD.
The London-based respiratory drug developer is reporting that interim results from the first part of its Phase II trial — showing that its dry powder inhaler formulation of ensifentrine helped patients improve lung function — look promising enough to go ahead with part 2.
In the trial, 37 patients with moderate-to-severe chronic obstructive pulmonary disease were divided into six groups: a placebo arm, and five ensifentrine cohorts each receiving one out of five different dosage strengths of the drug: 150 µg, 500 µg, 1500 µg, 3000 µg, or 6000 µg. Tracking their responses to a single dose, investigators found peak forced expiratory volume in one second — or FEV1, a common measure of lung function — “increased from baseline in a dose-dependent manner (ranging from 68 mL to 333 mL, p<0.05 doses 1500 µg and above).”
Based on the average FEV1 from 0-4 hours and 0-12 hours, Verona feels confident moving into the next part of the Phase II trial, which will evaluate the formulation in the same patient population over one week with twice-daily dosing.
“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,” said an upbeat Jan-Anders Karlsson, CEO, in a statement.
Investors didn’t seem to share the enthusiasm, though. Verona’s shares on the Nasdaq $VRNA stayed flat in pre-market trading.
A success there will be crucial for Verona as proof that ensifentrine, or RPL554, can be the first-in-class dual bronchodilator and anti-inflammatory agent that it claims to be — especially given that the nebulizer formulation has recently failed one of its own Phase II tests, causing its shares to slump.
In that trial, ensifentrine failed to confer a statistically significant improvement in FEV1 after the morning dose on day 3 of the 3-day treatment.
The company nevertheless sees the upside in secondary endpoints, including peak FEV1 over time and reductions in mean residual volume, and plans to conduct long-term studies with a new design.
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