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Entera Bio Outlines Phase 3 Trial Plans and Phase 2 Data for Oral Osteoporosis Candidate EB613

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ENTX$2.46 −1.20%

Entera Bio Ltd. (ENTX) has detailed the plan for its Phase 3 clinical trial testing EB613, an oral parathyroid hormone tablet candidate designed to treat osteoporosis. The late-stage study will enroll approximately 900 patients over 12 months, comparing EB613 against placebo in a two-to-one ratio. The primary goal of the trial will measure changes in total hip bone mineral density after 12 months of treatment.

Alongside the Phase 3 design, the biotech company highlighted post-hoc analysis from its six-month Phase 2 study, which previously met its bone mineral density and biomarker goals. The updated analysis demonstrated stronger anabolic effects and greater bone density improvements in women with baseline T-scores of -2.5 or lower. An effective oral tablet could offer a significant alternative to injectable osteoporosis treatments if clinical success continues.

Investors and healthcare regulators will closely watch whether EB613 achieves statistically significant bone mineral density gains and maintains an acceptable safety profile during Phase 3 testing. Demonstrating clear clinical efficacy in this large trial will be a crucial milestone for potential regulatory approval and market adoption.

Key points

  • Entera Bio Ltd. (ENTX) outlined a Phase 3 clinical trial enrolling about 900 patients for its oral osteoporosis candidate, EB613.
  • The 12-month placebo-controlled study will use total hip bone mineral density at one year as its primary endpoint.
  • Post-hoc Phase 2 analysis showed stronger bone density gains in osteoporosis patients with baseline T-scores of -2.5 or lower.
  • The candidate previously met its key bone density and biomarker objectives in a six-month Phase 2 study.

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Questions and answers

What is Entera Bio's Phase 3 study design for EB613?

Entera Bio is conducting a 12-month Phase 3 trial with about 900 patients testing EB613 against placebo in a two-to-one ratio. The main endpoint is total hip bone mineral density at 12 months.

What did Entera Bio's Phase 2 data show for EB613?

The six-month Phase 2 trial met its bone density and biomarker goals. A post-hoc analysis showed stronger anabolic effects and bone density gains in women with baseline T-scores of -2.5 or lower.

What type of drug is Entera Bio developing with EB613?

EB613 is an oral parathyroid hormone tablet candidate being developed to treat osteoporosis.