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Wednesday, 07/22/2020 6:50:05 PM

Wednesday, July 22, 2020 6:50:05 PM

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Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today the results from two primary market research studies of clinicians who treat osteoporosis patients. The studies were conducted by a third-party firm with a goal of gaining a better understanding of the perceived value and potential market penetration of an orally-delivered parathyroid hormone product in the treatment of osteoporosis. The survey populations were comprised of clinicians who frequently prescribe osteoporosis products including endocrinologists, gynecologists, orthopedists, and general practitioners, with over 70% of their osteoporosis patients having moderate to severe osteoporosis. One study surveyed clinicians in the U.S., Canada, and Europe, and the second surveyed clinicians in Japan. In the two studies, physicians were presented with a description of an oral PTH product that provides similar efficacy and safety of injectable PTH without the need for daily subcutaneous injections. The responses to the prospect of prescribing an oral PTH were overwhelmingly positive, driven by expected improvements in patient compliance, ease of administration, and without injection site discomfort. Physicians also considered reduced costs to patients and payers to be important features. Entera’s EB613 oral PTH is currently in Phase 2 clinical development for the treatment of osteoporosis, a multi-billion dollar global market.
“We are very pleased with the data from this important global market survey which very clearly validates the value proposition of our lead drug candidate, EB613. Due to the high cost, inconvenience, and pain associated with injectable osteoanabolic products, which are currently the standard of care for treating moderate to severe osteoporosis, it is estimated that only 5% of patients with severe osteoporosis actually receive treatment for their disease,” stated Entera CEO Adam Gridley. “The results of this market analysis confirm Entera’s view that an oral PTH tablet meets an unmet physician and patient need and can potentially grow the number of patients receiving treatment. Remarkably, approximately 45% of the participating physicians indicated the oral PTH would be their first line treatment choice for their patients with severe osteoporosis.”

The study conducted in the U.S./Canada/Europe included 100 clinicians with roughly 80% of the respondents from North America and 20% from Europe. Two-thirds of the clinicians were rheumatologists or endocrinologists with the balance equally split between orthopedists and general practitioners. The study conducted in Japan included 75 clinicians, approximately three-fourths of which were orthopedists. In both studies, patients treated by the physicians were predominantly female, and by progression of disease, the distribution of the patients was approximately 21% with early/mild osteoporosis, approximately 48% with moderate osteoporosis, and approximately 31% with severe osteoporosis. Clinicians in both studies were in general agreement that a safe and effective oral PTH may greatly reduce the use of PTH injectables for the treatment of osteoporosis, drastically changing the market by increasing patient comfort and compliance.




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