BridgeBio Pharma Initiates P-III Study (CALIBRATE) of Encaleret for Autosomal Dominant Hypocalcemia Type 1
Shots:
- The company initiated the P-III study (CALIBRATE) evaluating the efficacy & safety of encaleret vs SoC in a ratio (2:1) in 45 patients aged ≥16yrs. with biochemical evidence of hyperparathyroidism & genetic confirmation of ADH1 for 24wks.
- In an ongoing P-IIb study, 92% achieved normal blood calcium levels in the absence of SoC, and 77% had achieved normal 24-hr urinary calcium excretion within the normal range @24wk. of outpatient treatment, was well-tolerated with no observed safety signals of clinical concern, and restored normal mineral homeostasis. The results were presented at ENDO 2022
- Encaleret has received FTD in the US while ODD in the US & EU. If encaleret is approved, it will be the first therapy indicated for ADH1
Ref: - Globenewswire | Image: BridgeBio Pharma
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