Verona hopes for COPD success following ‘stellar’ phase 2 results

Verona Pharma is pressing on with development of a chronic obstructive pulmonary disease (COPD) drug, which it hopes could be a potential blockbuster with disease-modifying properties, following phase 2 results described by an analyst as “stellar”.

In an interview with pharmaphorum, CEO Jan-Anders Karlsson cautioned that the drug, codenamed RPL554, is still a long way from market – but said that given that treatment options for COPD are limited and the patient population is large, sales could be north of a billion dollars a year.

There will be another 18 months of phase 2 trials, plus several years of phase 3 testing before Verona is likely to produce data acceptable to regulators, he said.

But from what the company has seen so far, Karlsson said the drug could be a step-change in treatment of COPD. It is an inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzyme, and has the potential to act as a bronchodilator and an anti-inflammatory agent that could be added to existing therapies.

An analysis from broker N+1 Singer agreed, describing the trial results as “stellar”, adding that they are “extremely upbeat” about the firm’s prospects.

Karlsson said the plan is to investigate the drug as a maintenance therapy, or as a rescue therapy for patients within 30 days of discharge from hospital.

UK-based Verona will then decide whether to pursue one or both of these uses in phase 3 trials. Verona aims to complete phase 2 on its own and will search for a potential partner for phase 3. The company is also exploring development in cystic fibrosis.

Verona will also assess options about delivery devices. The drug is being developed as a treatment with a nebuliser, but Karlsson said it could also be delivered via an inhaler.

Figures from an “add-on” phase 2a trial, assessing the bronchodilator effect of nebulised RPL554 administered on top of salbutamol and ipratropium bromide in COPD, show RPL554 produced over 60% of additional bronchodilation on top of standard of care bronchodilators.

The bronchodilator effects seen with the combinations were significantly larger than those of either salbutamol or ipratropium bromide alone, which were in turn all significantly greater than placebo.

Data implies RPL554, alone or in combination with other bronchodilators, may reduce dyspnea (shortness of breath), a major debilitating symptom of COPD.

“It does seem to work in a complementary way. There are a lot of patients that will not be looking for an alternative but will be looking for something extra,” said Karlsson.

Karlsson is unfazed by Takeda’s already marketed Daxas (roflumilast) tablet, which has been on the market for several years, saying that results so far show an advantage as side effects of RPL554 are not as severe.

Daxas causes side effects such as diarrhoea, nausea, abdominal pain and headache. “Even if it is working they don’t feel the benefit,” he said.

Also about to hit the COPD market is AstraZeneca’s Bevespi Aerosphere (glycopyrrolate+formoterol fumarate), approved in COPD maintenance treatment in the US last month.

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