Shares of UK-based Verona Pharma plc (VRNA) soared nearly 45% on Thursday and added another 23% in extended trading as the Company awaits data from its phase IIb dose-ranging study evaluating the effect of nebulized Ensifentrine as an add-on to treatment with a long-acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease.
The Company’s lead product candidate Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act as both a bronchodilator and an anti-inflammatory agent in a single compound.
Ensifentrine, proposed for the treatment of chronic obstructive pulmonary disease (COPD), is under development in three formulations – a nebulized form, a dry powder inhaler (“DPI”) formulation, and a pressurized metered-dose inhaler (“pMDI”) formulation.
On January 14, 2019, the Company announced that its 3-day phase II trial evaluating nebulized Ensifentrine on top of dual bronchodilator therapy for chronic obstructive pulmonary disease maintenance treatment did not meet the primary endpoint of peak forced expiratory volume in one second (“FEV1”). Following the news, the stock plummeted 30% to close that day at $6.97.
The results of the second phase II trial – which is a four-week, placebo-controlled dose-ranging phase IIb trial evaluating nebulized Ensifentrine as an add-on to inhaled tiotropium, a long-acting anti-muscarinic (“LAMA”) commonly used to treat patients with chronic obstructive pulmonary disease – are due by this year-end or in the first quarter of 2020. This study will help inform the planned phase III clinical development program of nebulized Ensifentrine, which is expected to start in 2020, according to Verona.
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