Two years after flop, Verona gets a win as it preps for pivotal Phase III trials
Two years after the lead formulation of Verona’s lead COPD drug whiffed in a Phase II study that knocked back their stock, another formulation has hit across the board.
Verona said Tuesday that all four doses of an inhaler form of its compound ensifentrine significantly improved lung function in a 40-person Phase II trial of the chronic condition. Most doses of the drug hit on all primary and secondary endpoints, with the effect increasing with the dose.
On the primary endpoint of forced expiratory volume (FEV1) — a standard measure of lung function that tests how much breath one can forcefully exhale in 1 second — patients who received the high dose of the drug were able to exhale 326 more mL after 7 days of treatment, when adjusted for placebo. On the low dose, that figure was 205 mL. Both had P values <0.0001.
Verona’s stock $VRNA ticked up in response, rising 11% from $7.90 to $8.78.
The company has no immediate plans, though, on bringing the inhaler formulation into Phase III, a spokesperson said. Instead, executives are saying that it boosts the case for the nebulized form — the one that failed in 2019 but has hit on other studies, including a much larger one — as they push into two large, pandemic-delayed Phase III trials.
“We are very encouraged by these compelling data, which are consistent with results from Phase 2 clinical trials with our nebulized and DPI formulations of ensifentrine,” CEO David Zaccardelli said in a statement. “All three inhaled formulations have demonstrated significant improvements in lung function in COPD patients, supporting the broad utility of ensifentrine delivered via nebulizers and handheld inhalers.”
Verona, founded in 2005 and built solely around ensifentrine, argues that the molecule is the first that can both widen patients’ airways and reduce inflammation. In March 2018, they announced that, in a Phase IIb study of 400 patients, the nebulizer form beat placebo at improving lung function.
In 2019, the drug failed to significantly improve lung function in a three-day study when given on top of current COPD drugs. Last January, though, a longer study found the nebulized form did improve lung function when given on top of existing drugs, and Verona was able to raise nearly $200 million to launch a pair of pivotal Phase III studies, testing the drug both alone and in combination.
Nebulizers are electric devices that release pulmonary drugs as a mist and can offer some advantages over traditional inhalers.
The Verona spokesperson said they don’t plan on adding the inhaler formulation to the existing trials. Instead, they could look to apply it down the road to other indications, such as cystic fibrosis, or partner it out.