Entera Bio Announces Publication of Oral PTH(1-34) Peptide Tablets (EB613) Phase 2 Trial Data in the Journal of Bone and Mineral Research

JERUSALEM, April 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, announced today 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).

Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR. We believe EB613 addresses the current treatment gap in osteoporosis as the first oral, osteoanabolic (bone building) once-daily tablet treatment due to its unique format and potential dual mode of action. We remain highly committed to moving EB613 forward to meet the needs of patients.”

As reported in the Journal of Bone Mineral Research:

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.

We conclude that this PTH tablet might be the first effective orally administered bone building medication and should be studied further in treatment of women with osteoporosis.

Reference:

Liana Tripto-Shkolnik, Auryan Szalat, Gloria Tsvetov, Vanessa Rouach, Chana Sternberg, Anke Hoppe, Gregory Burshtein, Hillel Galitzer, Miranda Toledano, Gil Harari, Arthur C Santora, Felicia Cosman, Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, six-month, phase 2 study, Journal of Bone and Mineral Research, 2024, zjae057, 

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the into the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit or follow us on , , , .

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