The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor aims to reduce exacerbations in COPD patients and is 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 data and analytics firm GlobalData.
Key Opinion Leader (KOL) interviews conducted as part of GlobalData’s research have expressed positive opinions on the candidate drug.
Specifically, one KOL mentioned ensifentrine potentially preceding biologics in treatment options. Additionally, the KOL noted that if it is another nebulizer, it could be more accessible for COPD patients compared to biologics, which have not yet been marketed for COPD.
Verona’s PDE3/4 inhibitor gained the FDA’s interest after two positive phase 3 clinical trials (ENHANCE-1 and ENHANCE-2), both meeting their primary endpoints.
Asiyah Nawab, pharma analyst at GlobalData, said: “Ensifentrine has gained traction in the COPD market after two positive phase 3 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.
“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.”
Information shared at the conference indicated that the candidate drug demonstrated a notable improvement in dyspnea compared to the placebo within just 6 weeks, a benefit that persisted over 24 weeks, as assessed by the Transition Dyspnea Index.
By the end of the 24-week period, ensifentrine exhibited a clinically significant reduction in dyspnea by 65%.
Nawab adds: “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.”
Following the potential launch of their dual PDE3/4 inhibitor, expected in Q3 2024, Verona has further plans in development.
The company aims to submit an investigational new drug application to the FDA to commence a phase 2 clinical trial. This trial will evaluate the effectiveness and safety of a fixed-dose combination formulation comprising the candidate drug and glycopyrrolate (a long-acting muscarinic antagonist, LAMA) as a maintenance treatment for COPD patients, administered 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.”
Additional KOLs interviewed by GlobalData have voiced their enthusiasm 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."