Verona Pharma has announced that it is finalising preparations for the potential US launch of ensifentrine in the third quarter (Q3) of 2024, dependent upon the US Food and Drug Administration (FDA)’s approval of the company’s new drug application for this asset with the Prescription Drug User Fee Act date set for June 26, 2024.

Ensifentrine is a first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor administered as a nebulised formulation for chronic obstructive pulmonary disease (COPD) patients, aiming to reduce exacerbations in COPD cases. Verona Pharma’s PDE3/4 inhibitor gained the FDA’s interest after two positive Phase III clinical trials (ENHANCE-1 and ENHANCE-2) both met their primary endpoints.

Data presented at the American Thoracic Society (ATS) conference in May 2024 showed that ensifentrine was able to reduce exacerbation rate and risk over 24 weeks in COPD patients regardless of blood eosinophil levels compared to a placebo, with significant differences seen in some subgroups of eosinophils (>100 and <300 cells/uL). Additional data presented at the ATS conference conveyed that the candidate drug significantly improved dyspnea compared to the placebo as early as 6 weeks, and was maintained over 24 weeks, measured by the transition dyspnea index. At the end of 24 weeks, ensifentrine had clinically reduced dyspnea by 65%.

In preparation for this potential milestone, Verona has secured a financing deal of $650 million for ensifentrine’s launch, in addition to Verona’s existing cash of $255 million. The financing has been agreed with Oaktree Capital Management and OMERS Life Sciences, allowing Verona to access $400 million in term loans in five separate tranches, and up to $250 million from the sale of redeemable interest in future revenue generated by the candidate drug. This will provide Verona Pharma with the ability to fund planned operating expenses and capital expenditure beyond 2026, including the drug’s commercial launch in the US, if approved.

Data presented at the ATS 2024 conference communicated improved symptoms and health-related quality of life when ensifentrine was given alongside a long-acting muscarinic antagonist (LAMA) maintenance therapy consistently from Week 6 to Week 24, compared to placebo. The involvement of two optimistic agents to tackle symptoms and exacerbations as a fixed-dose product has great potential, post-approval of ensifentrine. Verona intends to submit an investigational new drug application to the FDA to initiate a Phase II clinical trial assessing the efficacy and safety of a fixed-dose combination formulation of the candidate drug and glycopyrrolate (a LAMA) as maintenance treatment for COPD patients via nebulisation.

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