Entera Bio (NASDAQ:ENTX) reported interim results from its Phase 2 trial assessing EB613 for the treatment of osteoporosis.
The trial has currently enrolled 131 postmenopausal female subjects with osteoporosis, or low bone mass density. Based on six-month data, EB613 generated a mean placebo-adjusted increase in lumbar spine bone mass density of 2.15% for the 14 patients in the 1.5 mg treatment arm, compared with the 16 patients in the placebo arm.
In addition, all EB613 treatment groups showed a significant dose-dependent trend in the percentage change in lumbar spine bone mass density.
“As potentially the first oral parathyroid hormone to treat osteoporosis patients, we note that EB613 has a bone biomarker profile that is different from subcutaneous parathyroid hormone,” Dr. Arthur Santora, Enetra’s CMO, said in a statement.
He noted that that interim lumbar spine bone mass density data are supportive of the 2.5 mg dose the company recently added to the study.
“Based on guidance from the FDA, and given positive final results from the current Phase 2 trial, we anticipate one global Phase 3 505(b)(2) non-inferiority study of EB613 as compared to Forteo, with a primary endpoint of a change in lumbar spine bone mineral density.”
Entera expects to complete trial enrollment of 160 patients by the end of the third quarter of 2020.
