The US Food and Drug Administration (FDA) granted Mereo BioPharma’s investigational oral neutrophil elastase inhibitor, alvelestat (MPH-966), Fast Track designation.
In May 2022, Mereo BioPharma released positive top-line results from its phase 2 clinical trial showing the safety and efficacy of alvelestat in treating patients with severe alpha-1 antitrypsin deficiency (AATD)-associated emphysema.
“AATD is a devastating inherited condition which severely affects patients’ quality of life. In the ASTRAEUS study, we demonstrated alvelestat’s ability to inhibit multiple specific biomarkers relevant to the disease pathway based on neutrophil elastase inhibition,” said Denise Scots-Knight, chief executive officer of Mereo. “We are grateful to the FDA for granting us Fast Track designation, and for their recognition of alvelestat as a potentially first-in-class oral neutrophil elastase inhibitor. We look forward to the R&D update on the alvelestat program this month, and to our future interactions with the FDA to review our plans for a pivotal trial.” The update is expected on October 31, 2022.
Given the urgency of therapeutic options to treat AATD-associated lung disease, Mereo BioPharma is planning an end-of-phase 2 meeting with the FDA to discuss future work to accelerate alvelestat approval, including the design of a registration-enabling study. The company plans to have the meeting toward the end of 2022.
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In addition, another phase 2, placebo-controlled trial (ATALANTa) is ongoing to investigate alvelestat in a broader cohort of patients with AATD, including those on augmentation therapy. Results are expected by mid-2023.
Alvelestat is also being studied in bronchiolitis obliterans syndrome, a rare condition characterized by excessive inflammation and thickening of the airways, which severely affects lung function.
Mereo BioPharma receives FDA Fast Track designation for alvelestat for treatment of alpha-1 antitrypsin deficiency (AATD)-associated lung disease. News release. Mereo BioPharma Group; October 17, 2022.