Shares in Verona Pharma (VRNA) are surging 10% in Wednesday’s pre-market trading, after the company announced the initiation of the second, multiple dose, part of a Phase 2 trial to evaluate the pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease (“COPD”).
COPD is an umbrella term encompassing a group of diseases that cause airflow restriction, blockage and other breathing problems.
Results from the study (Part B) are expected in the first half of 2021.
Positive efficacy and safety data from the first, single dose, part of the study (Part A) in 40 patients with moderate to severe COPD were revealed on March 31, 2020.
The results demonstrated a statistically significant and clinically meaningful increase in lung function compared to placebo.
However, Verona decided to postpone initiation of Part B of the study due to concerns for the safety of patients and study staff because of the COVID-19 pandemic. Following an assessment of local infection rates and control measures in addition to procedures put in place by the UK clinical sites, Verona has now initiated Part B, which will evaluate the pMDI formulation.
The trial will involve 30 moderate to severe COPD patients, who will be randomized to receive 3 dose levels of pMDI ensifentrine or placebo, twice-daily over one week. All patients will receive each of the dose levels and placebo over four 7-day treatment periods.
The primary endpoint is improvement in lung function as measured by peak FEV1 with ensifentrine compared to placebo after 7 days of treatment, with secondary endpoints including safety and tolerability.
David Zaccardelli, CEO of Verona, commented: “Data from the single dose part of this pMDI study are very encouraging and consistent with data from Phase 2 clinical trials with our nebulized and dry powder inhaler (“DPI”) formulations of ensifentrine.”
He continued: “pMDI and DPI formulations are important delivery mechanisms in the approximately $9.6 billion US market for maintenance COPD therapies.”
Shares in Verona have surged over 40% year-to-date, and the stock scores a bullish rating from both Wedbush and Canaccord Genuity. That’s with an average analyst price target of $20, indicating significant upside potential of 144% from current levels.
Canaccord Genuity’s Edward Nash has just initiated coverage on Verona with a buy rating and $17 price target, writing that he sees a ‘sizable market opportunity for refractory COPD patients.’
“Assuming a modest 8% penetration rate in 2029, the out-year of our model, and pricing at a 20% discount to nebulized drugs, we conservatively project Verona to book worldwide revenues of ~$1.1B” the analyst told investors on August 10.
With $25.7M in cash and equivalents reported at the end of 1Q20, and the recent close of a $200M financing, the company now has a sufficiently strong balance sheet to cover ensifentrine through to NDA (new drug application) submission. (See Verona stock analysis on TipRanks).