Verona Pharma has announced what it calls “encouraging interim results” from a Phase 1/2 study of a new formulation of its RPL554 PDE3/4 inhibitor for the treatment of COPD exacerbations. The company had announced the initiation of the 120-subject study of the nebulized formulation in January 2015 and now says that the trial is ahead of schedule.
According to Verona, the first portion of the study tested 5 dose levels in 50 healthy patients and was unable to define a maximum tolerated dose, with all dose levels tested well tolerated. The maximum dose tested was about 16 times larger than the dose tested in previous studies with the older formulation, the company said. PK data also indicate a significantly longer residence time in the lung for the new formulation compared to the older formulation.
Verona CEO Jan-Anders Karlsson commented, “We are very excited by this first set of clinical data generated with our new proprietary formulation for nebulised RPL554, which is consistent with the expected profile based on preclinical studies. We have already demonstrated in earlier trials that RPL554 has the unique ability to combine potent bronchodilation with broad anti-inflammatory activity in a single molecule. The studies we are now commencing, thanks to the excellent tolerability of our new formulation, will allow us to assess markedly higher doses of the drug than those used in our studies in COPD patients to date and seeks
to maximize the clinical impact of the drug. We look forward to reporting data from this important clinical study later in the course of 2015.”
Karlsson continued, “We are initially developing nebulised RPL554 as a treatment for acute exacerbations in COPD, where we believe it has significant market potential. We continue to believe that the emerging profile of RPL554 suggests that it could potentially become an important addition to available treatment options both as a monotherapy and, as a result of its unique mechanism of action, as a combination partner for existing drugs for COPD.”
The second portion of the study will involve administration of multiple ascending doses for five consecutive days in both healthy subjects and COPD patients. The company expects to have results in the second half of 2015.
Read the Verona Pharma press release.
