Encaleret Increased Bone Turnover and Improved Participant-Reported Symptoms in the Phase 3 CALIBRATE Trial in ADH1
Globe Newswire•11/10/2026•11:42 ET
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Key Highlights
- ➤Encaleret stimulated endogenous PTH to at least lower-normal levels in 91% of participants
- ➤Bone turnover markers increased with encaleret versus conventional therapy after 24 weeks
- ➤100% reported improvement in at least one ADH1 symptom versus 46% receiving standard of care
- ➤FDA granted Priority Review; PDUFA target action date is May 8, 2027
- ➤BridgeBio dosed the first participant in registrational Phase 3 RECLAIM-HP study
Expert Statements
Erik Imel, M.D., Indiana University School of Medicine
“In ADH1, suppressed PTH secretion results in hypocalcemia and a tendency toward an overall reduced bone turnover state. The observed increases in bone turnover markers following encaleret administration are consistent with the effects of restored endogenous PTH secretion. These findings suggest that encaleret is addressing the underlying biology of the disease, not just correcting blood calcium.”
Patty Keating, Executive Director of the HypoPARAthyroidism Association
“For people living with chronic hypoparathyroidism, the effects of inadequate disease control can build over time, potentially increasing the risk of kidney complications. Our community needs research that asks whether we can do better by reducing the long-term burden of managing the condition day to day. I am thrilled that the first participant was dosed in RECLAIM-HP as it is an important step toward answering that question.”
- Encaleret administration increased bone turnover, based on its action to recover endogenous PTH secretion in patients with ADH1
- 100% of participants who received encaleret reported improvements in at least one ADH1 symptom compared to 46% of participants who received standard of care
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