Mereo BioPharma announces Positive Top-Line Efficacy and Safety Data from Phase 2 ASTRAEUS Study of Alvelestat

Mereo BioPharma Group plc MREO announced positive top-line efficacy and safety results from phase 2 ASTRAEUS clinical study evaluating Alvelestat (MPH-966), in patients with severe alpha-1 antitrypsin deficiency-associated emphysema.

The phase 2 study evaluated two different doses of Alvelestat (high or low dose) for over a 12-week period at different intervals of four, eight and twelve weeks and the effect on three primary biomarker endpoints associated with AATD-related lung disease (AATD-LD),

A total of 98 patients were dosed in the study. At the high dose, Alvelestat demonstrated statistically significant changes versus placebo in all three primary biomarker endpoints.

Dr. Denise Scots-Knight, Chief Executive Officer, said, “Alvelestat has the potential to be the first-in-class oral neutrophil elastase inhibitor for the treatment of AATD-LD. We look forward to analyzing the additional data on the secondary and exploratory endpoints and to engaging with the regulators on the design of a pivotal study.”

Mereo BioPharma is trading high 11 percent at $0.65 in the pre-market session