LONDON (Alliance News) - Mereo BioPharma Group PLC said on Monday it has concluded an end of Phase Two meeting with the US Food & Drug Administration regarding acumapimod as a treatment for acute exacerbations of chronic obstructive pulmonary diseases.
Shares in the rare disease-focused biopharmaceutical company were down 4.9% at 157.00 pence on Monday.
In the meeting, the FDA and Mereo agreed in principle on an outline for the design of a Phase Three clinical trial programme to support the development of acumapimod as a five day treatment regimen for COPD patients.
The programme, which will enrol 800 patients consists of two randomised, double blind, placebo controlled studies which compares one dosing regimen of study drug on top of standard of care to placebo.
The primary endpoint will be the time to next severe exacerbation and the rate of severe exacerbations, while the secondary endpoints will include the rate of moderate exacerbations, reduction in systemic corticosteroid exposure and lung function.
Mereo is now expected to work with the FDA to finalise the Phase Three study design.
"We are pleased with this positive outcome from our meeting with the FDA, where we agreed, in principle, the design of the pivotal trial programme for acumapimod. This is a novel approach to treating the disease as patients are dosed during an acute exacerbation in order to reduce further exacerbations of COPD," said Chief Medical Officer Alastair MacKinnon.
"This builds directly on the positive data we generated in our successful phase 2 trial. We have previously stated our intention to partner acumapimod and believe that the outcome of this meeting will help us to progress these discussions," MacKinnon added.