Hartaj Singh

Sema Sharan

- **Astria Therapeutics** has initiated the opening of clinical centers in the **European Union (EU)** for its **Phase 3 ALPHA-ORBIT trial** of **navenibart**.  **[1454789_de59815bad8e4471aab0962355b44dc2_0]** 
- Navenibart is an investigational monoclonal antibody designed to treat **hereditary angioedema (HAE)**, with potential for administration every **3 or 6 months**.  **[1454789_de59815bad8e4471aab0962355b44dc2_0]** **[1454789_de59815bad8e4471aab0962355b44dc2_1]** 
- The trial, authorized by the European Medicines Agency (EMA), plans to activate **32 centers** across **10 EU countries** and aims to enroll up to **135 adults and 10 adolescents** with HAE Type 1 or 2.  **[1454789_de59815bad8e4471aab0962355b44dc2_0]**

Astria Therapeutics expands Phase 3 ALPHA-ORBIT trial to EU

- Astria Therapeutics has commenced **patient enrollment in the European Union** for its **Phase III ALPHA-ORBIT trial** of **navenibart**, an investigational treatment for hereditary angioedema (HAE).  **[1454789_4824e9f949804f06b1ecd095bc271694_0]** 
- The trial is expanding to **10 EU countries**, including Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain, adding to existing sites in other global regions.  **[1454789_4824e9f949804f06b1ecd095bc271694_0]** 
- Navenibart is a plasma kallikrein monoclonal inhibitor being developed for HAE, with a potential dosing regimen of every **3 and 6 months**.  **[1454789_4824e9f949804f06b1ecd095bc271694_0]** **[1454789_4824e9f949804f06b1ecd095bc271694_1]** 
- The ALPHA-ORBIT trial is designed to assess the efficacy and safety of navenibart in up to **135 adults and 10 adolescents** with HAE type 1 or 2.  **[1454789_4824e9f949804f06b1ecd095bc271694_1]**

Astria Therapeutics Initiates EU Patient Enrollment for Phase III ALPHA-ORBIT Trial

- Astria Therapeutics has **begun enrolling Hereditary Angioedema (HAE) patients in the European Union** for its ALPHA-ORBIT Phase 3 study of navenibart.  **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_0]** 
- The ALPHA-ORBIT study is a **global, randomized, double-blind, placebo-controlled Phase 3 trial** evaluating the efficacy and safety of navenibart, an experimental monoclonal antibody inhibitor of plasma kallikrein, for HAE.  **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_0]** **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_1]** 
- Navenibart is designed for **subcutaneous administration every 3 or 6 months**.  **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_0]** **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_1]** 
- The European Medicines Agency (EMA) approval facilitates the activation of **32 sites across 10 EU countries**, including Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, and Spain.  **[1454789_1893a7a3e1d84f8cbe98cb8aa719c5dd_0]**

Astria Therapeutics Initiates EU Enrollment for ALPHA-ORBIT Phase 3 Study

- Astria Therapeutics has commenced opening clinical trial sites in the **European Union (EU)** and is now recruiting participants for the **Phase 3 ALPHA-ORBIT study** of **Navenibart**.  **[1454789_3c20b2c5fa134a8187069b297c4967c1_0]** 
- Navenibart is an investigational monoclonal antibody inhibitor of plasma kallikrein being developed for the treatment of **hereditary angioedema (HAE)**, with potential administration every three to six months.  **[1454789_3c20b2c5fa134a8187069b297c4967c1_0]** **[1454789_3c20b2c5fa134a8187069b297c4967c1_1]** 
- The European Medicines Agency (EMA) approval enables the activation of an anticipated **32 sites across 10 EU countries** for the ALPHA-ORBIT study.  **[1454789_3c20b2c5fa134a8187069b297c4967c1_0]** 
- The global ALPHA-ORBIT study is designed to evaluate the efficacy and safety of Navenibart, enrolling up to **135 adults and 10 adolescents** with HAE Type 1 or Type 2.  **[1454789_3c20b2c5fa134a8187069b297c4967c1_1]**

Astria Therapeutics (ATXS)