BBIO - BridgeBio starts phase 3 trial of encaleret for calcium disorder

• BridgeBio Pharma ( NASDAQ: BBIO ) said it started a phase 3 trial of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1).
• Patients with ADH1 have low blood calcium (hypocalcemia), inappropriately low parathyroid hormone levels, and excess excretion of calcium in the urine (hypercalciuria), according to the company.
• The study, dubbed CALIBRATE, will evaluate the efficacy and safety of encaleret for 24 weeks and will enroll ~45 people 16 years of age or older with evidence of hyperparathyroidism (low PTH, low blood calcium, high urinary calcium) and genetic confirmation of ADH1.
• BridgeBio said the the design of the trial includes feedback from global regulatory authorities and patients, with a primary composite goal of blood and urine calcium concentrations within normal ranges in participants treated with encaleret compared to standard of care (SoC).
• SoC for ADH1 consists of extra-dietary supplementation with calcium and/or active vitamin D analogs, the company added.
• The company noted that in an ongoing phase 2 trial in patients with ADH1, 69% of patients achieved concurrent values of both blood calcium and 24-hour urinary calcium excretion in the reference range.
• If approved, encaleret would be the first therapy specifically indicated for ADH1, BridgeBio added.

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