Verona Pharma upbeat on latest ensifentrine study data
Verona Pharma
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16:55 29/10/20
Biopharmaceutical company Verona Pharma announced positive phase 2 data with a dry powder inhaler formulation of its lead development product, ‘ensifentrine’, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) on Monday.
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The AIM-traded firm said all of the primary and secondary lung function endpoints were met in the phase 2 trial.
It said the primary endpoint was a “highly statistically significant and clinically meaningful” dose-dependent improvement in lung function, adding that the secondary lung function endpoints were also met, and the data appearing to be supportive of twice-daily dosing, with ensifentrine “well tolerated” at all dose levels.
Delivery via dry powder inhaler could “substantially expand” the clinical utility and commercial opportunity for ensifentrine in COPD, the company explained.
It aid ensifentrine in a handheld dry powder format was “well tolerated” at all doses, with an adverse event profile similar to placebo.
The safety profile was comparable to that observed in prior studies with nebulised ensifentrine.
“Achieving a bronchodilator response of this magnitude in COPD patients is clinically meaningful and very encouraging,” said Joseph A Boscia, pulmonary physician and principal investigator at Vitalink Research-Union in South Carolina.
“This highlights the potential for ensifentrine’s unique mechanism of action to provide lung function improvement and meet the urgent clinical need for new treatments for patients with this progressive and debilitating disease.”
Jan-Anders Karlsson, chief executive officer of Verona Pharma, added the data was “very promising”, with the dry powder inhaler formulation supporting the company’s view that ensifentrine was an effective bronchodilator in COPD patients, whether administered as a dry powder via a handheld inhaler or as a suspension via a nebuliser.
“Our proof-of-concept dry powder formulation can be adapted to different DPI devices used in the market.
“Millions of patients prefer to use a handheld device, and these data significantly expand ensifentrine’s commercial potential.
“We plan to complete further development and commercialisation of the DPI formulation with a partner and these clinical data strongly support this opportunity.”
In addition to the DPI formulation of ensifentrine, Verona Pharma said it was developing a pressurised metered-dose inhaler formulation of ensifentrine, adding it was expecting to report initial single dose data using the widely-used handheld inhaler format in the second half of 2019, with final multiple dose data from a one week study expected in the first quarter of 2020.
Progression of the nebulised suspension formulation of ensifentrine was continuing, with data from the ongoing phase 2b clinical trial expected around year-end.
Verona Pharma said it anticipated progressing the ensifentrine nebuliser formulation into phase 3 clinical trials in 2020.