Hypoparathyroidism
Overview
Parathyroid hormone (PTH) plays a critical role in controlling calcium, phosphate and vitamin D levels in the blood and bones. PTH directly involves the kidneys, bones, muscles, nerves and other organs in maintaining key biological functions.
Hypoparathyroidism is a rare condition in which the body fails to produce sufficient amounts of PTH or the PTH produced lacks normal biologic activity. Individuals with a deficiency of parathyroid hormone may exhibit hypocalcemia and hyperphosphatemia.
Hypocalcemia can cause weakness, muscle cramps, excessive nervousness, headaches and uncontrollable twitching and tetany.
Hyperphosphatemia can result in soft tissue calcium deposition, which may lead to severe issues, including damage to the circulatory and central nervous systems.
Market
Over 200,000 people are estimated to be afflicted with hypoparathyroidism worldwide, with approximately 43% of cases characterized as mild, 39% characterized as moderate, and 18% characterized as severe.
Unmet Need
Historically, standard treatment for hypoparathyroidism includes calcium supplements, calcitriol or “active vitamin D” analogs and occasionally phosphate binders, the chronic use of which may result in serious side effects and significant costs to patients and healthcare systems.
Significant Unmet Need Remains
>200K
Patients (US + EU)
Predominantly women
~75%
Post-surgical cases
Throid/Parathyroid surgery
Daily
Injection burden
Palopegteriparatide (Yorvipath. 2024)
Entera’s EB612 is the first oral long acting PTH (1-34) hormone replacement treatment developed in a tablet form, that may have inherent advantages as compared to injectable and small molecule approaches in terms of potential superior safety and to provide more individualized treatment in this heterogeneous disease.
Oral Peptide
Tablet friendly for patient compliance.
Differentiation vs small molecules (Safety, DDI).
Sustain PTH Exposure
Prolonged plasma half-life >72h.
Potential low mg daily dose.
Cross-Species Preclinical Validation
Pharmacodynamic effect in TPTx rat and two large animal species - providing a robust translational package for IND-enabling studies.
Well Tolerated
Favorable early tolerability signal.
