Verona Pharma recently announced that they are finalizing preparations for a potential US launch of Ensifentrine in the third quarter of 2024, depending upon the FDA’s approval, set for June 26, 2024. The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor aims to reduce exacerbations in chronic obstructive pulmonary disease (COPD) patients, administered as a nebulized formulation. The asset has gained positive opinions in the US market after data presented during the American Thoracic Society (ATS) 2024 conference earlier this month showed a paradigm shift in COPD treatment, according to GlobalData, a leading data and analytics company.
Interviews with Key Opinion Leaders (KOLs) as part of GlobalData research have expressed positive opinions on the candidate drug. One KOL, in particular, expressed Ensifentrine sliding in before the biologics. He added that if it’s another nebulizer, it is easier to give to a COPD patient over biologics, as they have not been marketed yet for COPD.
Verona’s PDE3/4 inhibitor gained the FDA’s interest after two positive Phase III clinical trials (ENHANCE-1 and ENHANCE-2), both meeting their primary endpoints.
Asiyah Nawab, Pharma Analyst at GlobalData, comments: “Ensifentrine has gained traction in the COPD market after two positive Phase III clinical trials. Data presented at the ATS 2024 conference showed that Ensifentrine was able to reduce the exacerbation rate and risk over 24 weeks in COPD patients regardless of blood eosinophil levels compared to the placebo, with significant differences seen in some subgroups of eosinophils (>100 and <300 cells/uL). In addition to this, not only did the agent reduce exacerbation rate and risk, but the asset was also able to tackle a significant symptom of COPD, dyspnea, which is prevalent in most COPD patients.”
Data presented at the conference conveyed that the candidate drug significantly improved dyspnea compared to the placebo as early as 6 weeks, and was maintained over 24 weeks, as measured by the Transition Dyspnea Index. At the end of 24 weeks, Ensifentrine had clinically reduced dyspnea by 65%.
Nawab continues: “Verona recently secured a financing deal of up to $650 million for Ensifentrine promising launch, in addition to Verona’s existing cash of $255 million. This will provide the pharmaceutical company with the ability to fund planned operating expenses and capital expenditure beyond 2026, including the drug’s commercial launch in the US, if approved.”
Verona has other plans in the pipeline after the potential launch of their dual PDE3/4 inhibitor, anticipated for Q3 2024. They intend to submit an investigational new drug application to the FDA with the intention to initiate a Phase 2 clinical trial assessing the efficacy and safety of a fixed-dose combination formulation of the candidate drug and glycopyrrolate (long-acting muscarinic antagonist, LAMA), as maintenance treatment for COPD patients, via nebulization.
Nawab continues: “The combination of two optimistic agents to tackle symptoms and exacerbations as a fixed-dose product has great potential, post-approval of Ensifentrine. Data presented at the ATS 2024 conference communicated improved symptoms and health-related quality of life when Ensifentrine was given alongside LAMA maintenance therapy consistently from Week 6 to Week 24, compared to placebo.”
Other KOLs interviewed by GlobalData have expressed their excitement for Ensifentrine, “mainly because it’s a novel target, so we can’t underestimate the value of novel targets”.
Nawab concludes: “Following the presentation of the data at the ATS conference as well as insights from KOLs interviewed at GlobalData, the potential launch of Verona’s Ensifentrine is one to keep an eye on pre-, during and post-approval of the agent. It will be interesting to see how the asset will navigate through the COPD market, and perhaps even for other respiratory conditions in the near future.”
