StockMarketWire.com - Mereo BioPharma Group said it had held a successful meeting with the US Food and Drug Administration regarding a treatment for the reduction of acute exacerbations of chronic obstructive pulmonary disease.

In the Type B end of Phase 2 meeting, Mereo and the FDA discussed, and agreed in principle, an outline for the design of a pivotal Phase 3 clinical trial programme.

The programme would support the development of acumapimod as a five-day treatment regimen for patients undergoing severe exacerbations of COPD.

It consisted of two randomised, double blind, placebo controlled studies comparing one dosing regimen of study drug on top of standard of care to placebo plus SOC.

The trials were expected to enrol around 800 patients each, for which the primary end point would be the time to next severe exacerbation/rate of severe exacerbations.

Mereo would now work with the FDA to finalize the pivotal Phase 3 study design.


At 9:40am: [LON:MPH] Mereo Biopharma Group Ltd share price was 0p at 165p



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