UK-based Mereo BioPharma has reported a positive outcome from its Phase 1 drug interaction study with acumapimod, an active compound in the company’s novel p38 MAP kinase inhibitor BCT-197.
BCT-197 is currently undergoing a Phase 2 study for the treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
An AECOPD is characterised by a sudden worsening in the COPD patient’s symptoms of dyspnoea, cough and sputum production.
Acute exacerbations last for several days and need an increase in medication, as well as lead to frequent hospitalisation.
While AECOPDs occur in the natural course of the disease and are commonly triggered by infections and air pollution, one third do not have an identifiable trigger. Both airway and systemic inflammation are characteristic drivers of the disease.
This study analysed potential drug interactions between acumapimod and the antibiotic azithromycin.
The trial confirmed no drug interaction or evidence of adverse effects on safety and tolerability, thereby indicating that acumapimod may therefore be dosed with azithromycin.
Mereo chief medical officer Dr Alastair Mackinnon said: “We are delighted to announce the results of our Phase I drug interaction study.
“Patients with COPD frequently use azithromycin in the management of acute exacerbations and some use it as a maintenance therapy for their disease.
“The results of this study are encouraging as they remove restrictions on patients already taking azithromycin for the ongoing clinical programme and allow physicians to use this common antibiotic in the management of AECOPDs alongside BCT-197.”
The company is also conducting a Phase II study to assess different dosing regimens of BCT-197 along with the standard care to treat AECOPD patients in a hospital setting.
Image: Lung bulla spotted in a person with severe COPD. Photo: courtesy of James Heilman.