AstraZeneca says CALYPSO Phase III trial met composite primary endpoint

AstraZeneca (AZN) said positive results from the CALYPSO Phase III trial showed that eneboparatide, an investigational parathyroid hormone 1 receptor agonist, met its composite primary endpoint, demonstrating a statistically significant and clinically meaningful normalisation of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium supplements in adults with chronic hypoparathyroidism at week 24. n the trial, 31.1% of patients treated with eneboparatide met the composite primary endpoint, achieving sCa within normal range and independence from oral supplements at week 24, compared with 5.9% of patients in the placebo group. Immunogenicity was observed in the majority of patients, resulting in reduced treatment effects in some patients. sCa was controlled with the aid of supplements and up-titration of eneboparatide. CALYPSO also met all key secondary endpoints at week 24, including normalisation of urinary calcium excretion in patients with hypercalciuria at baseline. This was achieved in 56.6% of these patients in the eneboparatide group compared to 20% in the placebo group. Eneboparatide also demonstrated statistically significant improvements in patient-reported outcomes reflecting disease-specific core physical symptoms and physical functioning, as well as SF-36 Physical Function Subscore.