Verona Pharma plc VRNA announced that it has initiated two phase III studies — ENHANCE-1 and ENHANCE-2 — to evaluate nebulized formulation of its pipeline candidate, ensifentrine, as a maintenance treatment for moderate-to-severe chronic obstructive pulmonary disease (“COPD”).
The company will file regulatory application seeking approval for ensifentrine, a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound, based on data from these pivotal studies, if successful.
Ensifentrine, as a monotherapy or added onto a maintenance bronchodilator, has demonstrated significant and clinically meaningful improvements in lung function, symptoms and quality of life in earlier-stage studies.
Both studies will evaluate the safety and efficacy of twice daily 3 mg nebulized dose of ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA (“long acting muscarinic antagonist”) or a LABA (“long acting beta-agonist”), compared to nebulized placebo over a period of 24 weeks. Additionally, ENHANCE-1 will evaluate longer-term safety of both regimens over 48 weeks.
The primary endpoint of the studies is improvement in lung function as measured by forced expiratory volume in one second (“FEV1”) over 12 hours after 12 weeks of treatment.
Shares of Verona Pharma have increased 10.1% year to date while the industry remained flat.
Apart from nebulized formulation, Verona Pharma is also developing two other formulations of ensifentrine — a dry powder inhaler and a pressurized metered-dose inhaler — for treating COPD. Both these formulations are in mid-stage development. The company is also developing ensifentrine as a potential treatment for other respiratory disorders including COVID-19, asthma and cystic fibrosis.
However, we note that there are several established treatments available for COPD including Glaxo’s GSK Trelegy Ellipta. Theravance Biopharma TBPH also markets a once-daily nebulized COPD medicine, Yupleri. Meanwhile, AstraZeneca’s AZN is developing its asthma drug, Fasenra, for treating COPD. These drugs will likely be a strong competitor for ensifentrine, following its approval.
Verona Pharma PLC American Depositary Share Price
Verona Pharma PLC American Depositary Share price | Verona Pharma PLC American Depositary Share Quote
Verona Pharma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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