- 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

- Improvements in ADH1-related impacts on daily functioning were also more frequently reported with encaleret compared to standard of care

- The FDA has accepted BridgeBio’s NDA for encaleret in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027; the Company also submitted an MAA to the EMA

- The first participant was dosed in RECLAIM-HP, the registrational Phase 3 study of encaleret in adults and adolescents with chronic hypoparathyroidism

BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, presented bone turnover results and patient-reported outcomes from the Phase 3 CALIBRATE trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1). The data were presented in oral presentations at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting in Boston, Massachusetts. Additionally, the Company dosed the first participant in RECLAIM-HP, its registrational Phase 3 study of encaleret in adults and adolescents with chronic hypoparathyroidism.

Erik Imel, M.D. of Indiana University School of Medicine, presented an oral presentation on 24-week CALIBRATE data showing that encaleret-mediated increases in parathyroid hormone (PTH) may help restore native bone physiology in ADH1. Key findings include:

• Encaleret stimulated endogenous PTH secretion to at or above the lower limit of normal in 91% of participants, compared with 0% on standard of care (SoC)
• Bone turnover markers increased in the encaleret-treated group vs conventional therapy, as assessed by markers of bone formation and resorption
  
  

“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,” said Dr. Imel. “These findings suggest that encaleret is addressing the underlying biology of the disease, not just correcting blood calcium.”

Additionally, Steven Ing, M.D. of Ohio State University and CALIBRATE Investigator, presented an oral presentation on patient-reported outcomes demonstrating that treatment with encaleret improved ADH1 symptom burden and daily functioning compared to participants treated with standard of care (calcium supplementation and/or active vitamin D). Key findings include:

• 100% of participants who received encaleret reported improvements in at least one ADH1 symptom compared to 46% of participants who received standard of care
• Symptom improvement with encaleret treatment compared to SoC at 24 weeks included fatigue (61.3% versus 27.3%), muscle cramps (58.1% versus 36.4%), muscle spasms (58.1% versus 18.2%), tingling (51.6% versus 9.1%) and brain fog (48.4% versus 9.1%)
• Improvements in ADH1-related impacts on daily functioning were more frequently reported with encaleret compared to SoC, including mood and emotions (61.3% versus 27.3%), physical activities (45.2% versus 9.1%), daily life (35.5% versus 18.2%) and work life (35.5% versus 9.1%)
  
  

In partnership with the HypoPARAthyroidism Association (HPA), BridgeBio also shared findings in a poster from regional family genetic testing events that evaluated a proband-initiated model designed to bring no-cost genetic testing and counseling directly to at-risk relatives in their home region. Key findings include:

• 44% of participants (N=27) were symptomatic at the time of testing, and 77% of those individuals had exhibited symptoms for more than 2 years
• BridgeBio and HPA will continue to support regional family genetic testing via this model, which may offer an innovative and scalable approach to shorten the path to diagnosis for families affected by ADH1
  
  

BridgeBio also dosed the first participant in RECLAIM-HP (NCT07805356), a global, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of oral encaleret in adults and adolescents with chronic hypoparathyroidism. Approximately 160 participants will be enrolled and randomized 3:1 to receive encaleret or placebo during the 24-week double-blind treatment period. The primary endpoint is the proportion of participants achieving both blood and urine calcium within the target range at Week 24. Key secondary endpoints include reduction in and/or independence from conventional therapy, patient reported outcomes, bone mineral metabolism, and long-term safety.

“For people living with chronic hypoparathyroidism, the effects of inadequate disease control can build over time, potentially increasing the risk of kidney complications,” said Patty Keating, Executive Director of HPA. “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.”

The first participant dosed in RECLAIM-HP follows a period of significant progress for the encaleret program. The FDA has accepted BridgeBio’s NDA for encaleret in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027. The Company has also submitted an MAA to the EMA for encaleret in ADH1.

In addition to the oral presentations and posters related to ADH1, BridgeBio also shared a poster featuring data showing a lack of peripheral FGFR1 inhibition at clinically relevant infigratinib exposures, supporting the safety profile observed in children with achondroplasia in the PROPEL clinical program.