Entera Bio Ltd. announced that data from the Phase 2 Trial of its lead clinical compound, EB613 (Oral PTH(1-34) Tablets) for the Treatment of Post-Menopausal Women with Low BMD or Osteoporosis compared to placebo were published in the Journal of Bone and Mineral Research (JBMR). Despite the superior benefits of bone building (anabolic) agents and guidelines supporting their use, these medications are used in a minority of patients for whom they are appropriate, in part because they require daily or monthly injections, which limit patient acceptance. An oral anabolic tablet has potential to address this substantial treatment gap.

In this double-blind, placebo controlled, dose-finding randomized study, 161 postmenopausal women with low bone mineral density or osteoporosis were treated with varying doses of the active part of parathyroid hormone [PTH (1-34), EB613] or placebo given in daily oral tablets for 6 months. The highest EB613 oral PTH tablet dose (2.5 mg), produced an increase in markers of bone formation while simultaneously decreasing the markers of bone breakdown. Significant gains in bone mineral density of the spine and hip were observed at the end of the 6-month study and there were no significant safety concerns.

The 2.5 mg oral PTH tablet dose was well tolerated when patients were instructed to titrate up to the full dose.