Osteoporosis

Overview

Osteoporosis, or ‘porous bone’, is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Osteoporosis is a silent disease until it is complicated by fractures that occur following minimal trauma or, in some cases, with no trauma. Men as well as women are affected by osteoporosis, a disease that can be prevented and treated. Osteoporosis is a progressive bone disease that is characterized by a decrease in bone mass and density. It occurs when the total bone lose exceeds the total bone formation. As a result, the bones become weak and have an increased chance of breaking or fracturing. The risk factors include aging, female, low body weight, low sex hormones or menopause, smoking, and some medications. Prevention and treatment include calcium and vitamin D supplements, exercise, and medications.

There are two categories of osteoporosis medications: antiresorptive medications that slow bone loss and anabolic drugs that increase the rate of bone formation.
Antiresorptive medications include bisphosphonates which interfere with bone resorption while PTH is an anabolic (bone forming) drug.

Although PTH (teriparatide) would be the drug of choice for this disease, the high cost, low dosing flexibility and inconvenience of a daily injection, make it less desirable for patients. Entera’s platform technology has taken PTH and enabled it to be delivered orally which should lead to higher compliance rates. Additionally, physicians would potentially prescribe the oral PTH 1-34 to a wider population of osteoporosis patients and at an earlier stage of the disease.

Market

Osteoporosis is a global public health problem currently affecting more than 200 million people worldwide. An estimated 10 million people in the United States have osteoporosis, and another approximately 43 million have low bone mass placing them at increased risk for osteoporosis.

The "Global Osteoporosis Market, Patients, Companies Forecast" 2015 research report expects the global osteoporosis market to be more than US$ 40 Billion by 2019.
Other market analysis also forecast significant growth in the coming years reaching as high as a 17.43% CAGR.

Current Status

We intend to pursue approval of EB613 utilizing the alternative Section 505(b)(2) pathway permitted under the Federal Food, Drug and Cosmetic Act. Our intent is to seek FDA guidance as part of a Pre-IND meeting in the second half of 2018. Based on the response of the FDA, we intend to conduct a dose ranging Phase 2a study in approximately 150 osteoporosis patients. Following analysis of this data, we will design and execute pivotal trial(s) in osteoporosis patients guided by the feedback of the FDA.


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