AstraZeneca’s CALYPSO Trial Report: Eneboparatide Shows Promise for Chronic Hypoparathyroidism

Here's a summary of the key information extracted from the financial report:

Company Overview

• Company Name: AstraZeneca PLC
• Location: Cambridge Biomedical Campus, Cambridge, United Kingdom
• Report Type: Form 6-K

Trial Results

• Trial Name: CALYPSO Phase III trial
• Drug Investigated: Eneboparatide (AZP-3601), a parathyroid hormone (PTH) receptor 1 agonist
• Target Condition: Chronic Hypoparathyroidism (HypoPT)
• Key Outcome: The trial met its primary endpoint with statistical significance at 24 weeks, demonstrating normalization of serum calcium levels and independence from active vitamin D and oral calcium therapy.
• Patient Population: The trial included 202 adults diagnosed with chronic hypoparathyroidism.
• Trial Design: Randomized, double-blind, placebo-controlled.

Implications

• Patient Impact: HypoPT is a rare endocrine disease affecting over 200,000 people in the U.S. and EU, predominantly women. The results of this trial suggest that eneboparatide could provide a new treatment option for these patients.
• Next Steps: The trial will continue for 52 weeks to further assess the drug's risk-benefit profile and full efficacy and safety data will be analyzed at that time.

Regulatory Status

• Eneboparatide has received fast track and orphan drug designations from the U.S. FDA, and orphan designation from the European Medicines Agency.

CEO Statement

• Marc Dunoyer, CEO of Alexion, AstraZeneca Rare Disease, highlighted the potential of eneboparatide to address unmet needs in treating HypoPT, especially in preventing complications like hypercalciuria and osteoporosis.

Conclusion

The positive results from the CALYPSO trial could potentially position AstraZeneca as a key player in the treatment landscape for chronic hypoparathyroidism, addressing a significant unmet medical need in a sizable patient population. Further data will be crucial for full regulatory approval and market entry.