By Chris Wack

Entera Bio Ltd. said it has concluded its end-of-Phase 2 meeting with the U.S. Food and Drug Administration on EB613, its oral formulation of human parathyroid hormone for the treatment of osteoporosis.

Entera Bio shares were up 19% to $3.85 in premarket trading.

The company said the meeting defined the path for Phase 3 development of EB613, confirming that a fracture study won't be necessary and that lumbar spine bone mineral density at 12 months can be the primary endpoint.

The meeting followed completion of its Phase 2 clinical trial, which met its endpoints, including increases in lumbar spine, femoral, neck and hip bone mineral density versus placebo after six months of treatment, and demonstrated a safety profile consistent with subcutaneous PTH.

Based on FDA feedback at the meeting, Entera said that it is currently proceeding with its plans for a Phase 3 registration study of EB613 this year.

The company said the FDA confirmed that a comparison of Entera's EB613 dosed at 2.5 mg versus subcutaneous PTH with a lumbar spine BMD increase at 12 months as the primary endpoint for the trial would be acceptable. The company may rely on marketed drugs as part of a 505(b)(2) regulatory approval pathway. The FDA's 505(b)(2) new drug application pathway helps avoid unnecessary duplication of studies already performed on previously approved drugs.

If approved, EB613 would be the first oral anabolic agent for the treatment of osteoporosis. Entera said it expects to begin enrollment in its Phase 3 study in 2022.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

01-04-22 0923ET