Entera Bio Announces Key Regulatory Milestone For Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling On Qualifying BMD As A Surrogate Endpoint For Osteoporosis Drugs is Expected Within 10 Months

Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of orally delivered peptides, announced today that The American Society for Bone and Mineral Research (ASBMR) announced on March 25 2024 that the U.S. Food and Drug Administration (FDA) has communicated to the SABRE (Study to Advance BMD as a Regulatory Endpoint) project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
 

The proposed registrational Phase 3 study for EB613, Entera's lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.

"Following our positive placebo-controlled Phase 2 study and multiple Type C and Type D meetings held with FDA from June 2022 through 2023, we designed our phase 3 study for EB613 to meet the SABRE quantitative target BMD thresholds which have been shown to correlate to reductions in vertebral, non-vertebral and all site fracture risk. We believe EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative which is also the first biomarker to potentially be approved as part of the 2016 21st Century Cures Act. In November 2023 we issued a press release echoing ASBMR's announcement that SABRE had submitted its final qualification package to FDA for the replacement of fracture as a regulatory endpoint. Today we are thrilled to echo ASBMR's announcement that FDA has set a concrete timetable to issue its ruling. As the first potential oral tablet osteoanabolic treatment, EB613 holds the potential to address the treatment chasm in this severe, potentially lethal disease which remains significantly undertreated despite efficacious injectable treatments. Fracture rates continue to rise globally, and we have not seen any new drugs approved for osteoporosis since 2019, largely due to the ethical concerns, long duration and costs of fracture endpoint studies. Our discussions with key clinicians and patient advocacy groups and other key stakeholders in this ecosystem indicate that an oral anabolic treatment is warranted and a potential ‘game changer' for the estimated 200 million women with osteoporosis globally," said Miranda Toledano, CEO of Entera.

The below is an excerpt from ABSMR March 25th press release1:

According to the Centers for Disease Control and Prevention, more than 53 million people in the United States alone have or are at a high-risk for osteoporosis, a bone disease that develops when bone mass decreases, leading to an increase in the risk of fractures. Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men. Patients and their families collectively spend an estimated $52 billion annually in healthcare costs for osteoporosis-related bone breaks, an expense that is predicted to double in the next decades due to the increased aging of the US population.

"Preventing and treating osteoporosis-related fractures isn't just about strengthening bones; it's about enhancing quality of life and saving lives," added ASBMR President Laura Calvi, MD. "Embracing BMD as a surrogate endpoint in clinical trials will revolutionize the journey of novel therapeutic agents to the clinic, reducing both time and costs, and ultimately it will  lead to improved treatment options for individuals with osteoporosis."