BioCentury·· 18 hours agoPickScore83
Disc’s Phase III win addresses FDA’s concerns about bitopertin’s efficacy
In brief
Disc Medicine (NASDAQ:IRON) announced that the GlyT1 inhibitor bitopertin met both co-primary endpoints in the Phase III APOLLO trial in erythropoietic protoporphyria (EPP). Versus placebo, whole-blood protoporphyrin IX (PPIX) levels fell 41.4% (p<0.0001), and average monthly pain-free light exposure time in month six increased 12.2 hours (p=0.001). Shares rose nearly 40% after hours.
Why it matters
The 41.4% PPIX reduction and 12.2-hour gain in pain-free light exposure let readers judge whether the biomarker efficacy dispute is answered by clinical endpoints.
Source: BioCentury