Entera Bio (NASDAQ:ENTX) completed enrollment in its Phase 2 trial evaluating EB613 for the treatment of osteoporosis.
EB613 is an orally delivered human parathyroid hormone designed to build bone in osteoporosis patients.
The trial enrolled 161 postmenopausal female subjects with osteoporosis or low bone mineral density. Women are being randomized to receive either 1.5 mg or 2.5 mg of EB613, or placebo. The study’s primary endpoint is the mean change in baseline P1NP, a marker of bone formation, after three months of treatment.
“There is a clear and compelling need for an oral parathyroid treatment that builds bone in patients with osteoporosis and we look forward to reporting the full topline results from this trial in the second quarter of 2021,” Roger Garceau, M.D., Entera’s interim CEO, said in a statement.
Entera expects to report efficacy results and three-month biomarker data in the first quarter of 2021.
