Acceleron Discontinues Mid-Stage Muscular Dystrophy Study
Zacks Investment Research | Sep 17, 2019 10:33PM ET
Acceleron Pharma Inc. (NASDAQ:XLRN) announced the discontinuation of a phase II study evaluating its pipeline candidate, ACE-083, in patients with facioscapulohumeral muscular dystrophy (FSHD). Although the candidate achieved growth in muscle volume in FSHD patients, it failed to deliver a meaningful functional benefit on top of it.
Data from the study showed that ACE-083 achieved statistically significant increase in mean total muscle volume, the study’s primary endpoint. However, the company announced that the increase in muscle volume failed to translate into improvements in functional tests of statistical significance, representing secondary endpoints. This failure resulted in the company’s decision to discontinue further development of the candidate in FSHD patients.
So far this year, Acceleron stock has gained 2.7% against the granted Orphan Drug designation to sotatercept for PAH earlier this month.
In June, Acceleron completed enrolling patients in the PULSAR study and plans to report top-line data from the same in the first quarter of 2020. Also, the company is currently recruiting subjects in the SPECTRA exploratory study to have a better understanding of sotatercept's potential impact on PAH. Preliminary results from this study are expected in 2020.
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