BridgeBio Pharma Reports Positive Phase 3 Encaleret Data and Doses First Patient in New Trial
BridgeBio Pharma, Inc. (BBIO) presented clinical data showing that its experimental drug encaleret restored native parathyroid hormone secretion and increased bone turnover in patients with autosomal dominant hypocalcemia type 1 (ADH1). In the 24-week Phase 3 trial, 91% of encaleret-treated participants achieved normal hormone secretion levels compared to none on standard therapy, while every patient on encaleret reported improvement in at least one symptom.
The findings indicate that encaleret targets the underlying cause of ADH1 rather than only managing blood calcium levels. Patients receiving encaleret experienced notable reductions in fatigue, muscle cramps, and brain fog, alongside improved daily functioning compared to traditional treatments.
Regulatory agencies are reviewing encaleret for ADH1, with the U.S. Food and Drug Administration granting Priority Review and assigning a target action date of May 8, 2027. Meanwhile, BridgeBio has begun dosing participants in a separate Phase 3 trial evaluating encaleret for chronic hypoparathyroidism.
Key points
- BridgeBio Pharma presented Phase 3 trial results showing encaleret restored hormone secretion and boosted bone turnover in ADH1 patients.
- All participants taking encaleret reported symptom improvements, compared to 46 percent on standard of care.
- The U.S. FDA accepted the drug application under Priority Review with a target action date of May 8, 2027.
- BridgeBio dosed the first participant in its global Phase 3 RECLAIM-HP study for chronic hypoparathyroidism.
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What were the key Phase 3 trial results for BridgeBio's encaleret?
Encaleret restored parathyroid hormone secretion to normal levels in 91% of ADH1 patients and improved symptoms in 100% of participants, outperforming standard of care.
When will the FDA decide on encaleret approval?
The U.S. FDA accepted the drug application under Priority Review and set a target action date of May 8, 2027.
What other clinical trials is BridgeBio conducting for encaleret?
BridgeBio has dosed the first patient in RECLAIM-HP, a global Phase 3 study testing encaleret in adults and adolescents with chronic hypoparathyroidism.