Entera Bio Ltd. (Nasdaq: ENTX), announced today the positive outcome of a pre-IND meeting held with the US Food and Drug Administration (FDA) to discuss the Company’s development plan for Oral PTH for the treatment of osteoporosis. The feedback and guidance were summarized in the formal meeting minutes that Entera subsequently received from the FDA. In addition to discussing various aspects of the nonclinical and clinical development plan, the meeting focused on the 505 b(2) regulatory pathway and the use of bone mineral density (BMD) rather than fracture incidence as the primary endpoint to support a New Drug Application (NDA). Based on the FDA’s response, Entera believes that the Phase 3 study may use BMD as the primary efficacy endpoint and that a fracture endpoint study will not be required.
“We were very pleased with the positive pre-IND meeting with the FDA in late 2018 and greatly appreciate the detailed guidance in FDA’s official minutes of the meeting,” stated Dr. Arthur Santora, Chief Medical Officer of Entera Bio. “As we anticipated, the FDA expressed its willingness to accept Entera’s plan to bridge nonclinical and clinical study data for our oral PTH (1-34) to data from prior studies of the commercially available PTH (1-34) injection (Forteo®). The FDA provided us with an overall direction for the nonclinical and clinical and regulatory path forward; successful bridging between the effects of oral PTH and subcutaneous PTH would allow Entera to conduct a Phase 3 study with a bone mineral density efficacy endpoint rather than fracture endpoint study. While a BMD endpoint study comparing Oral PTH and subcutaneous PTH is still a large study, it would be substantially less costly and several years shorter than a fracture endpoint trial.”
Entera Bio’s Oral PTH (1-34) has been shown to produce a blood level profile similar to Forteo® (teriparatide), which was approved by the FDA in 2002 for the treatment of osteoporosis in men and postmenopausal women who are at high risk for fractures. “Forteo® is currently one of two injectable treatments for osteoporosis which are classified by the FDA as “bone building” (anabolic). The potential osteoporosis drug market is estimated at almost $20 billion worldwide. If a “blockbuster” drug with comparable efficacy to injectable Forteo® were available as a once-daily pill, we believe that it would potentially win market share and significantly expand the market for anabolic agents to osteoporotic patients at high risk of fracture who are reluctant to use an injectable medication,” stated Dr. Phillip Schwartz, CEO of Entera Bio.
Post FDA feedback, the Company is proceeding with the development of EB-613 for osteoporosis. The next step in this clinical development program will be to conduct a dose-ranging study in approximately 140 osteoporosis patients, in order to study both safety and the optimal dose to advance into a Phase 3 pivotal study. This dose-ranging study will commence in the first half of this year and will include bone marker, bone mineral density and safety endpoints. The Company will be conducting several nonclinical safety assessment studies in parallel. Assuming a favorable outcome of these studies, the Company is planning a single Phase 3, multicenter study comparing Oral PTH with Forteo® over a 12-month treatment period, to begin in 2020. Although still at the early stages of planning, such a study would likely be conducted in the U.S. and Europe, and potentially enroll between 600 and 800 patients in total, depending on statistical powering assumptions.
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