FDA to Rule on BMD as Surrogate Endpoint for EB613 Osteoporosis Drug in 10 Months

Entera Bio, a pioneering company in the field of orally delivered peptides, has made a significant announcement regarding its lead clinical candidate, EB613. This innovative treatment is a novel daily tablet for osteoporosis, which is designed to meet the quantitative bone mineral density (BMD) targets outlined by the SABRE initiative. The U.S. Food and Drug Administration (FDA) has informed the SABRE project team that they will provide a decision on whether to accept the treatment-related change in BMD as a surrogate endpoint for fractures in upcoming trials of new anti-osteoporosis drugs within the next ten months.

EB613 is poised to be the first oral osteoanabolic treatment, which could revolutionize the treatment landscape for osteoporosis, a disease that is significantly under-treated despite the availability of effective injectable treatments. The global rise in fracture rates and the lack of new osteoporosis drugs since 2019 highlight the urgent need for new treatment options. Entera's CEO, Miranda Toledano, has expressed optimism about EB613's potential to fill this treatment gap, citing the support from clinicians, patient advocacy groups, and other stakeholders.

The American Society for Bone and Mineral Research (ASBMR) has highlighted the prevalence of osteoporosis in the United States, where over 53 million people are affected or at high risk. The condition, which leads to decreased bone mass and an increased risk of fractures, particularly impacts postmenopausal women and older men. The financial burden of osteoporosis-related fractures is substantial, with an estimated $52 billion spent annually on healthcare costs in the U.S. alone.

ASBMR President Laura Calvi, MD, has emphasized the importance of improving treatment options for osteoporosis, stating that it is not only about strengthening bones but also about enhancing the quality of life and saving lives. The acceptance of BMD as a surrogate endpoint in clinical trials could streamline the development of new therapeutic agents, reducing the time and costs associated with bringing these treatments to patients.

Entera Bio is a clinical-stage company dedicated to developing oral peptide or protein replacement therapies for conditions with significant unmet medical needs. The company's proprietary technology platform is being used to develop a pipeline of first-in-class oral peptide programs, with five expected to enter clinical trials by 2025. EB613, the company's most advanced product candidate, is being developed for post-menopausal women with low BMD and high-risk osteoporosis. A Phase 2 study of EB613 tablets demonstrated positive results, meeting its primary and secondary endpoints.

Entera is also developing EB612, an oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism, as well as an oral oxyntomodulin for the treatment of obesity and an oral GLP-2 peptide tablet for patients with rare malabsorption conditions, in collaboration with OPKO Health.