On Monday, AstraZeneca Plc (NASDAQ:AZN) released high-level results from the CALYPSO Phase 3 trial designed to evaluate the efficacy and safety of eneboparatide in adults with chronic hypoparathyroidism.
The study showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance at 24 weeks in adults with chronic hypoparathyroidism (HypoPT) compared to placebo.
The primary endpoint is a composite of normalization of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy.
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HypoPT is a rare endocrine disease caused by a deficiency of PTH and is characterized by impaired regulation of calcium and phosphate levels in the blood. Eneboparatide was well tolerated.
After the 24-week randomized treatment period, all patients receive eneboparatide in the ongoing long-term extension until 52 weeks. Full efficacy and safety data will be analyzed at 52 weeks.
Concurrently, AstraZeneca and Alteogen entered into an exclusive license agreement for ALT-B4, a hyaluronidase utilizing Hybrozyme platform technology.
Under the terms of the agreement, AstraZeneca will acquire worldwide rights to use ALT-B4 to develop and commercialize subcutaneous formulations of several oncology assets.
Alteogen will be responsible for the clinical and commercial supply of ALT-B4 to AstraZeneca.
AstraZeneca will pay Alteogen an upfront payment and additional payments upon achieving specific development, regulatory, and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialized products.
On Monday, the European Union approved AstraZeneca’s Imfinzi (durvalumab) as monotherapy for adults with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
The approval is based on results from the ADRIATIC Phase 3 trial.
The trial showed that Imfinzi reduced the risk of death by 27% compared to placebo.
The estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.
Imfinzi also reduced the risk of disease progression or death by 24% versus placebo.
The median progression-free survival (PFS) was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.
Earlier on Monday, AstraZeneca agreed to acquire cell therapy focused-EsoBiotec SA for up to $1 billion.
Price Action: At the last check on Monday, AZN stock was down 1.04% to $76.78 during the premarket session.
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