BridgeBio Pharma Inc BBIO shares are trading higher by 16.77% to $7.87 Thursday afternoon after the company initiated its CALIBRATE Phase 3 study of Encaleret.
BridgeBio Pharma says the design of the CALIBRATE study incorporates feedback from global regulatory authorities and patients, with a primary composite endpoint of blood and urine calcium concentrations within normal ranges in participants treated with encaleret compared to standard of care (SoC).
The company says SoC for ADH1 consists of extra-dietary supplementation with calcium and/or active vitamin D analogs. While SoC may address acute symptoms related to hypocalcemia, it may exacerbate high urine calcium levels, which can cause renal complications1. Secondary endpoints will evaluate other measures of mineral homeostasis, quality of life, and kidney function.
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"We are excited to have reached this important milestone in the development of encaleret," said Mary Scott Roberts, executive director of clinical development at BridgeBio and clinical lead of the encaleret program.
"The pivotal CALIBRATE study will evaluate the potential for encaleret to provide a meaningful benefit to patients and families living with ADH1. If successful, this study could lead to an approval of encaleret for the treatment of ADH1, a disease with significant unmet medical need and no interventions specifically indicated for its treatment."
According to data from Benzinga Pro, BBIO has a 52-week high of $18.13 and a 52-week low of $4.98.
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