Positive Feedback From the EMA and FDA on Alzprotect’s Phase 2b/3 Development Strategy for PSP

LILLE, France--(BUSINESS WIRE)-- 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.

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Regulatory authorities have provided crucial insights into various design elements, with a particular focus on selecting study endpoints pertinent to the PSP indication and ensuring that the demographic and characteristic profile of the study sample closely mirrors the global PSP population. This feedback has armed Alzprotect with a valuable roadmap, enabling the refinement of the intended Phase 2/3 study protocol to ensure seamless alignment with scientific standards and regulatory requirements. With well-defined regulatory pathways for the PSP indication, Alzprotect’s forthcoming Proof of concept randomized controlled PROMISE-PSP trial, scheduled to commence in late 2024, is set to deliver outcomes that align with scientific and regulatory expectations across the United States and the European Union.

Dr. Artin Karapet, our Chief Medical Officer, expressed his heartfelt joy stating, “I am truly delighted to witness this alignment between agencies from different shores on critical program elements. Their guidance not only paves a feasible path forward but also brings AZP2006 one step closer to our patient community.”

Phil Verwaerde, Chief Executive Officer, added, “The alignment with regulatory authorities marks a pivotal moment for ALZPROTECT. It validates our vision and the potential of Ezeprogind/AZP2006 not only for PSP but also for a broader neurodegenerative disease spectrum. We are dedicated to accelerating our efforts to meet the urgent needs of patients.”

The molecule, AZP2006, proposes a fundamentally distinct mechanism of action compared to existing treatments: Targeting the root causes of neurodegeneration by stimulating the action of a protein essential to the functioning of the brain, Progranulin.

AZP2006 has shown excellent safety and promising efficacy in human trials, including 102 healthy subjects across three Phase I trials and 36 PSP patients in a Phase 2a trial. Alzprotect plans to initiate a randomized Phase 2b/3 proof of concept for PSP and expand its drug development to include Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis in the coming years.

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