EB613 (PTH 1-34) is the first and most advanced oral, daily tablet (6mm diameter) formulation teriparatide, consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®.
To date, we have completed two, Phase 1 clinical trials and a placebo-controlled Phase 2 double-blind, dose-ranging trial of EB613 in 118 patients with osteoporosis. The dose ranging Phase 2 study in postmenopausal women with low bone mass met its primary and key secondary endpoints and was presented in a late-breaker oral presentation at the 2021 ASBMR Annual Meeting (See presentation slides here). For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. 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. EB613 exhibited was well tolerated, with no drug related serious adverse events.
On October 4th we reached agreement with the FDA that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613 under the regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients (See Press release October 6th).
- International Osteoporosis foundation accessed March 2022; Salamanna, F. et al.
- Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. Eur J Rheumatol. 2017 Mar;4(1):46-56.
- Triangle Insights (TIG) Primary Research April 2022; Low BMD Category based on AACE guidelines (Camacho 2020, Endo Practice)
- IQVIA prescription data (note the capture rate of IQVIA may be low due to injectable administration of anabolic drugs on the market); TIG Primary Research April 2022
Our lead product candidate for hypoparathyroidism, EB612, is formulated as a daily tablet (6mm diameter) form of PTH hormone therapy.
We successfully completed a pilot Phase 2a trial for EB612 in 2015 using a 4x a day dosing. EB612 induced a rapid decline in median serum phosphate levels and maintenance of target calcium levels throughout the study, even as patients were able to meaningfully reduce their calcium and active vitamin D supplementation which is key to reducing common comorbidities of this disease.
In 2019, we reported the results of a second Phase 2 clinical trial that included one day of dosing with EB612.
The results from this study demonstrated that EB612 was effectively delivered into the blood stream and activated PTH-dependent biological pathways that are inadequately activated in patients with hypoparathyroidism. The pilot 4-month Phase 2 results for EB612 were presented at ASBMR 2015 and published in a peer-reviewed journal, JBMR, in 2021.
We have since developed an improved formulation of EB612 based on new intellectual property, with the potential for reduced daily dosing for hypoparathyroidism. We expect to carry out a PK study for the new formulation of EB612 in the first half of 2023.