Phase 2 Results for EB613 Oral Peptide Tablets in Postmenopausal Osteoporosis Published

Entera Bio Ltd. announced the publication of data from its Phase 2 trial of EB613, an oral PTH(1-34) tablet, in the Journal of Bone and Mineral Research. This trial focused on post-menopausal women with low bone mineral density (BMD) or osteoporosis. The study highlighted the potential of EB613 as the first daily oral treatment designed to stimulate bone growth, addressing a significant gap in current osteoporosis treatment options.

The company's CEO, Miranda Toledano, stated that the acceptance and publication of the Phase 2 study data demonstrates the promising future of EB613. She stressed the company's commitment to advancing EB613 to cater to the needs of osteoporosis patients.

The published data indicated that despite the known benefits of bone anabolic agents, their usage remains limited due to the inconvenience of daily or monthly injections. An orally administered treatment like EB613 could significantly improve patient compliance and treatment outcomes.

The double-blind, placebo-controlled study involved 161 postmenopausal women with low BMD or osteoporosis. Participants received varied doses of the EB613 oral tablet or placebo for six months. The highest dose (2.5 mg) of EB613 resulted in increased markers of bone formation and decreased markers of bone resorption. By the end of the study, significant improvements in spine and hip BMD were observed with no major safety concerns. Furthermore, the 2.5 mg dose was well-tolerated among participants.

The researchers concluded that EB613 could become the first effective oral bone anabolic medication and warranted further investigation for treating osteoporosis in women.

Entera Bio specializes in developing orally administered peptide therapies to meet significant unmet medical needs. Their proprietary technology platform supports a pipeline of first-in-class oral peptide programs. Aside from EB613, which is being developed as a daily treatment for osteoporosis, the company is also working on EB612, an oral PTH(1-34) tablet for hypoparathyroidism. Additionally, Entera is developing an oral oxyntomodulin for obesity and an oral GLP-2 peptide tablet for malabsorption conditions like short bowel syndrome.