JERUSALEM, Sept. 12, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced the details of “A Six-month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass – Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN-591)” poster presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting 2022, being held from September 9-12th in Austin, Texas. The full text of the abstract will be published to the ASBMR meeting website, and the e-poster will be viewable on Entera’s website as of Sunday September 11th as of 1pm CT.
The correlation results were derived from Entera’s six-month phase 2 Study of lead clinical candidate, EB613 (EBP05), the first daily oral hPTH (1-34) teriparatide formulation in 161 post-menopausal women with low bone mass. The primary endpoint of change in P1NP at 3 months and secondary endpoints of change in lumbar spine (LS), total hip and femoral neck Bone Mineral Density (BMD) were met, as previously reported (ASBMR 2021 poster FRI-237 and oral presentation LB-1116). The current abstract and poster presentation reveals excellent correlations between the dose of the oral formulation of EB613 and teriparatide hPTH(1-34) plasma concentrations at the 15 min time point (R =0.996) and a linear dose response for the change in lumbar spine BMD after 6 months of treatment (R =0.998).
“These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. This finding is consistent with excellent correlation between change in lumbar spine BMD and dose of EB613 after 6 months of treatment,” Said Dr. Arthur Santora, Chief Medical Officer at Entera.
“We are encouraged by this important correlation analysis from our positive phase 2 study of EB613. Recent debates at the ASBMR annual conference highlight the importance of potentially earlier intervention with osteoanabolic agents capable of repairing bone structure and increasing mass; versus initial treatment with anti-resorptive drugs that mostly stop bone loss. EB613 has unique potential in the osteoporosis treatment paradigm as the first convenient, daily tablets form of osteoanabolic treatment,” said Miranda Toledano, Chief Executive Officer of Entera.
About EB613 (a.k.a. EBP05)
Parathyroid hormone (PTH) is an 84-amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1-34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo® (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera’s oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera’s Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late-breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose-related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p