Verona Pharma to progress COPD treatment to phase 3 trials
Verona Pharma has stated that they will be taking their lung drug RPL554 into late clinical development after successful results from the phase 2b trial.
Shares in the UK biotech have risen by as much as 12% recently following the announcement. Verona already had strong support from analysts, with the likes of N+1 Singer and Jeffries giving “strong buy” and “buy” ratings respectively.
Trial data show that RPL554 produced clinically and statistically significant improvements in lung functions at all dose levels in chronic obstructive pulmonary disease (COPD).
Sudden hospitalisations caused by the disease place a major strain on patients, their families, and the health system, as yet no-one has found a drug that can halt the disease’s progress.
The trial was testing RPL554, a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 with bronchodilator and anti-inflammatory properties, as a maintenance treatment for COPD.
RPL554 produced a clinically and statistically significant improvement in peak forced expiratory volume (FEV1) in one second at four weeks in patients with moderate-to-severe COPD compared with placebo.
The peak FEV1 was significantly improved at all time points over four weeks of dosing, and secondary endpoints measuring 12 hour average FEV1, COPD symptoms and quality of life were also met.
The four-week, double-blind, placebo-controlled, parallel group, phase 2b multicentre European study performed in the out-patient setting evaluated the efficacy, safety, and dose-response of nebulised RPL554 administered twice-daily as a maintenance treatment for COPD in 403 patients with moderate-to-severe COPD.
There were four dosing arms of RPL554 in the study in addition to placebo and patients were required to withhold use of regular long-acting bronchodilator therapy for the duration of the study.
Verona said the results support the “potential clinical benefits of RPL554 for treatment of COPD.”
Verona pharma’s CEO Jan Anders Karlsson told pharmaphorum that the company plans to take the drug into phase 3 trials, potentially for use in combination with existing therapies.
Karlsson could not provide specifics about what combinations could be studied in phase 3 until a full review of the latest data is complete.
“We are looking at different options for designing phase 3 trials that the FDA would accept and payers would accept,” said Karlsson.
Verona is in talks with regulators, and is also conducting “market research” to try and design trials that would support price negotiations should RPL554 make it to market.
“We do need more clarity from payers about their expectations,” he said.
“It is very important to get them to accept that this is a new treatment, what we have seen today is something different,” Karlsson added. “We want to see how we can position this drug so it is as attractive as possible to payers.”
Phase 3 trials could start next year, and take a further two years to complete, Karlsson said.