Alzprotect Announces FDA Clearance of IND for AZP2006 (Ezeprogind®) in Progressive Supranuclear Palsy (PSP)
Alzprotect today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for AZP2006 (Ezeprogind®) for the treatment of Progressive Supranuclear Palsy (PSP). FDA clearance permits the Company to begin clinical development of AZP2006 in the United States.
Alzprotect Announces Supportive Results from Open-Label Extension of Phase 2a Study for Progressive Supranuclear Palsy (PSP)
Alzprotect, a French biopharmaceutical company, is pleased to announce the successful completion of the open-label extension (OLE) phase following the Phase 2a clinical trial of AZP2006 (ezeprogind®) for the treatment of Progressive Supranuclear Palsy (PSP). The findings from this 6-month extension phase underscore the potential of AZP2006 to stabilize/delay disease progression in PSP patients, particularly when administered early in the disease course.
Positive Feedback From the EMA and FDA on Alzprotect's Phase 2b/3 Development Strategy for PSP
ALZPROTECT is thrilled to announce that it has received favorable feedback from both the American (FDA) and European (EMA) authorities regarding the regulatory path for advancing the clinical development of Ezeprogind/AZP2006 for patients with PSP. This significant milestone follows the already very promising results of the phase 2a study in PSP and marks a decisive advancement. It will provide a clear path for the further development of Ezeprogind/AZP2006 within both scientific and regulatory expectations.
