IND enables initiation of U.S. clinical development in 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.

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“FDA IND clearance is a pivotal step in our PSP program,” said Philippe Verwaerde, PhD, President & Chief science Officer. “We can now expand our clinical efforts in the U.S. to evaluate AZP2006’s potential to address PSP, a severe neurodegenerative disease with no approved disease-modifying therapies.”

Dr. Artin Karapet, Chief Medical Officer, commented: “The FDA’s clearance of our IND for AZP2006 is a pivotal milestone, aligning U.S. and European regulatory pathways and enabling the initiation of rigorous clinical trials in the United States for patients living with PSP.”

Upcoming U.S. Clinical Study

This IND clearance enables U.S. clinical development and supports Alzprotect’s planned participation in the NIH/NIA-funded Progressive Supranuclear Palsy Trial Platform (PTP). AZP2006 was selected as one of the first candidates for evaluation in the PTP, reinforcing the relevance of Alzprotect’s lysosomal dysfunction approach in PSP.

About Progressive Supranuclear Palsy (PSP)

PSP is a rare, rapidly progressive tauopathy characterized by postural instability, falls, ocular motor dysfunction, and cognitive impairment. There are no approved disease-modifying treatments for PSP in the U.S.

About AZP2006 (Ezeprogind®)

AZP2006 is an innovative small oral molecule designed to restore lysosomal homeostasis by modulating the Progranulin/Prosaposin pathway, thereby targeting core mechanisms of neurodegeneration rather than symptoms alone. With Orphan Drug Designation in both Europe and the United States for PSP, AZP2006 has shown a favorable safety profile and promising clinical signals in Phase 1 and Phase 2a studies. Alzprotect now plans to advance AZP2006 into a randomized Phase 2b proof-of-concept trial in PSP, with potential expansion into other neurodegenerative diseases, including Parkinson’s, Alzheimer’s, and ALS.

About Alzprotect

Founded in 2007 in Lille, France, Alzprotect develops innovative therapies aimed at slowing or halting neurodegenerative diseases and restoring brain function. The company is supported by BPIfrance, the French National Research Agency, and Eurasanté, and its portfolio is protected by four international patent families. Learn more at www.alzprotect.com.

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FDA clearance of AZP2006’s IND marks a key step toward U.S. clinical development in Progressive Supranuclear Palsy, enabling Alzprotect to advance its lysosomal dysfunction approach for patients with no approved disease-modifying treatment options.