Entera Bio Phase 2 Study Met Primary and Key Secondary Endpoints

 

• Subjects receiving the 2.5 mg dose of EB613 showed significant dose-related increases in BMD at the lumbar spine, total hip, and femoral neck at 6 months

• Subjects receiving the 2.5 mg dose of EB613 for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008)

• The study’s primary efficacy endpoint, a statistically significant increase in P1NP at 3 months was achieved, as previously reported

• EB613 exhibited an excellent safety profile, with no drug related serious adverse events

• An End of Phase 2 meeting with FDA to review the EB613 development program is anticipated in the coming months. It is planned to conduct a single pivotal one-year Phase 3 study comparing changes in lumbar spine BMD in patients treated with EB613 versus treatment with Forteo®, as per a 505(b)(2) pathway

• EB613 is positioned to be the first oral bone building agent for the treatment of osteoporosis

Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule and biologic therapeutics, announced the final 6-month bone mineral density (BMD) results from the completed Phase 2 clinical trial of EB613 for the treatment of osteoporosis. EB613 is an oral formulation of human parathyroid hormone (1-34), or PTH, positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients. Currently, fewer than 5% of osteoporosis patients on any form of therapy are treated with an injectable anabolic agent, widely accepted as the most effective form of treatment1. The Phase 2 clinical trial of EB613 was a 6-month double blind, dose-ranging, placebo-controlled study in 161 postmenopausal female subjects with osteoporosis, or with low bone mineral density (BMD). This study was conducted at four leading medical centers in Israel to evaluate the safety and efficacy of varying doses of EB613. All lab tests including biomarkers and safety monitoring were performed at a certified central laboratory, and BMD data from clinical sites was analyzed at an independent certified global imaging center.

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