Michael Yee

Brian Abrahams

Jay Olson

Rudy Li

Tazeen Ahmad

Umer Raffat

Charles Duncan

Emma Seymour

Jason Butler

Neena Bitritto-Garg

- Prothena Corporation plc announced that its partner, Bristol Myers Squibb, has received **Fast Track Designation** from the U.S. FDA for **BMS-986446 (PRX005)**, an anti-MTBR-tau-targeting antibody for the treatment of early Alzheimer's disease.  **[1559053_1986f68b913e43f0aa64cfa2945a02e9_0]** 
- This designation is intended to **facilitate the development and expedite the review** of the investigational drug, which is currently in **Phase 2 development** and fully enrolled.  **[1559053_1986f68b913e43f0aa64cfa2945a02e9_0]** 
- BMS-986446 is being investigated as a potential disease-modifying therapy designed to **slow or delay the progression of Alzheimer's disease** by neutralizing the spread and promoting the clearance of pathological tau.  **[1559053_1986f68b913e43f0aa64cfa2945a02e9_0]** 
- Prothena is eligible to receive additional regulatory and sales milestone payments of up to **$562.5 million** and tiered royalties on net sales from Bristol Myers Squibb under their global license agreement.  **[1559053_1986f68b913e43f0aa64cfa2945a02e9_0]**

Prothena's Partner Bristol Myers Squibb Secures FDA Fast Track Designation for Alzheimer's Drug

- Prothena announced results from its **Phase 1 ASCENT clinical program** for **PRX012**, an anti-amyloid beta antibody for early symptomatic Alzheimer’s disease.  **[1559053_9a59e3fb82bc4b34a945a2e2e84f9d5e_0]** 
- The program demonstrated **dose- and time-dependent reductions in amyloid plaque**, with the **400 mg dose** achieving a mean reduction in amyloid PET to **27.47 centiloids (CL)** at month 12.  **[1559053_9a59e3fb82bc4b34a945a2e2e84f9d5e_0]** **[1559053_9a59e3fb82bc4b34a945a2e2e84f9d5e_2]** 
- However, **PRX012** was associated with **higher overall ARIA-E rates** relative to FDA-approved anti-Aβ antibodies, making it less appropriate for the patients studied.  **[1559053_9a59e3fb82bc4b34a945a2e2e84f9d5e_0]** 
- Prothena plans to **explore potential partnership interest** to advance **PRX012** and its preclinical **PRX012-TfR (transferrin receptor) antibody**, which is being developed to potentially lower ARIA risk.  **[1559053_9a59e3fb82bc4b34a945a2e2e84f9d5e_0]**

Prothena Announces Phase 1 ASCENT Clinical Program Results for PRX012

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