Entera Bio (NASDAQ: ENTX) has announced the end-of-phase meeting with the US FDA on EB613, the company’s oral formulation of human parathyroid hormone or PTH for osteoporosis treatment. The company also confirmed the path for the third phase development of EB613, which confirms that a fracture study will be required and that the lumbar spine BMD at twelve months will be the primary endpoint.
Entera advancing phase 3 EB613 study
The meeting came after the company’s Phase 2 clinical trial, which met all of its objectives, including increases in the lumbar spine, femoral, neck, and hip bone mineral density (BMD) after six months of treatment compared to placebo, and showed a safety profile similar to subcutaneous PTH (1-34) (teriparatide injection).
Entera is moving forward with its intentions for a third registration trial of EB613 this year, based on FDA responses obtained at the meeting. The FDA certified that a 12-month lumbar spine BMD gain as the primary objective for a trial comparing Entera’s EB613 administrated at 2.5 mg versus subcutaneous PTH (1-34) would be permitted. As part of the 505(b)(2) regulatory approval procedure, the company may rely on marketed medications.
EB613 is the first oral anabolic for osteoporosis treatment
EB613 will be the first ingested anabolic drug licensed for osteoporosis treatment once approved. Oral medicines are currently used to treat over 90% of osteoporosis patients. However, osteoporosis is a quiet condition where the patient has little or no discomfort until a bone is shattered. As a result, many elderly people are hesitant to take injectable medications.
CEO Spiros James said, “We are very pleased with the FDA’s guidance on our development plan for EB613 as we focus on the work necessary to secure regulatory approval to deliver an oral PTH option for patients with osteoporosis. As an oral bone building drug, EB613 has the potential to dramatically expand the use of PTH to those patients who are reluctant to use injectables. We look forward to commencing enrollment in the Phase 3 study in 2022.”
