Entera Bio received positive feedback from the FDA regarding its New Drug Application (NDA) for EB613, an oral treatment for postmenopausal osteoporosis. The FDA agreed that a single Phase 3 study with bone mineral density (BMD) as the primary endpoint would support the NDA filing, a departure from the traditional requirement of fracture incidence as the primary endpoint. This decision allows Entera to proceed with a more streamlined and potentially faster clinical development program.
This FDA decision is potentially transformative for osteoporosis drug development. It validates the use of BMD as a primary endpoint, potentially reducing the need for lengthy and costly fracture-based trials. This could accelerate the development of new osteoporosis therapies and, ultimately, provide patients with more treatment options sooner. For Entera, this reduces a significant hurdle and allows them to proceed expeditiously to Phase 3. This advantage could position EB613 as a leading oral anabolic treatment for osteoporosis, addressing a significant unmet need in a large patient population.
The FDA’s acceptance of BMD as a primary endpoint is based in part on the SABRE initiative, which provided compelling evidence correlating BMD gains with fracture risk reduction. Entera’s Phase 2 study of EB613 demonstrated positive results in BMD and bone turnover markers, supporting the rationale for using BMD as the primary endpoint in the Phase 3 trial. The upcoming Phase 3 trial will be a multinational, randomized, double-blind, placebo-controlled 24-month study in women with postmenopausal osteoporosis, evaluating changes in total hip BMD as the primary outcome and the incidence of new or worsening vertebral fractures as a key secondary endpoint.
This regulatory decision marks a potential turning point in osteoporosis drug development. It opens the door for faster and more efficient clinical trials, paving the way for new treatments to reach patients sooner. For Entera, this represents a significant step forward in the development of EB613 and strengthens its potential to become a first-in-class oral anabolic therapy for osteoporosis, addressing a significant unmet medical need. The results of the Phase 3 trial will be crucial in determining the future of EB613 and its impact on the osteoporosis treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
