Verona Pharma pleased with RPL554 trial top-line results

Clinical-stage biopharmaceutical company Verona Pharma announced top-line results from its clinical pharmacokinetic (PK) trial in the United States on Wednesday, which it said demonstrated that inhaled RPL554 is an “appropriate form of administration” for patients with chronic obstructive pulmonary disease (COPD) and other respiratory disorders.

The AIM-traded firm said that, with any inhaled or nebulised medication, a portion of the substance was deposited in the mouth and then swallowed by the patient.

It said the results showed that in the study subjects only 10.4% of the inhaled dose entered the bloodstream via the gastrointestinal tract.

The low oral bioavailability of nebulized RPL554, as demonstrated in the study, was consistent with “optimal inhaled delivery” of medications for the treatment of COPD and asthma.

As such, the results from the study confirmed that inhaled RPL554 would be an “appropriate form” of administration for patients, the board said.

The complete block two-way crossover trial evaluated a single dose of RPL554 in 12 healthy volunteers to determine the process of bodily absorption, distribution, metabolism and excretion of the novel therapy, including the swallowed portion of the nebulised dose.

Verona said the trial was conducted under an ‘Investigational New Drug’ application accepted by the US Food and Drug Administration in June, and it was reporting top-line results earlier than expected.

"[This] data demonstrates that inhalation of RPL554 is an appropriate route of administration for people with COPD and other respiratory diseases,” said Verona Pharma CEO Jan-Anders Karlsson.

“The low oral bioavailability seen in this PK trial reinforces that the swallowed portion of the medication contributes very little to the effects of RPL554.”

Karlsson said the inhaled portion provided “novel” bronchodilator and anti-inflammatory effects, and had limited systemic exposure.

“We believe that our ability to consistently deliver higher doses of RPL554 directly to the lungs, while at the same time having only low levels in the bloodstream, is consistent with a promising therapeutic effect, and we continue to see good tolerability of the compound across our clinical trials.”