EMA and FDA Endorse Alzprotect's PSP Treatment Development

ALZPROTECT, a company dedicated to the advancement of treatments for neurodegenerative diseases, has recently received positive responses from both the FDA and EMA on the clinical progression of Ezeprogind/AZP2006 for Progressive Supranuclear Palsy (PSP) patients. This endorsement follows the promising phase 2a study results and represents a significant step forward in the development of the drug.

The regulatory bodies have offered vital advice on the study design, emphasizing the importance of selecting endpoints that are relevant to PSP and ensuring that the study's participants accurately represent the global PSP demographic. This guidance has provided ALZPROTECT with a clear plan to refine the Phase 2/3 study protocol, aligning it with both scientific rigor and regulatory compliance.

The upcoming PROMISE-PSP trial, which is set to begin in late 2024, aims to meet the scientific and regulatory expectations in both the United States and the European Union. Dr. Artin Karapet, Chief Medical Officer of ALZPROTECT, has expressed his excitement about the consensus between different regulatory agencies on key program elements, which he believes brings AZP2006 closer to the patient community.

Phil Verwaerde, CEO of ALZPROTECT, views the alignment with regulatory authorities as a crucial step for the company, validating their vision and the potential of Ezeprogind/AZP2006 for PSP and other neurodegenerative diseases. The company is committed to accelerating its efforts to address the urgent needs of patients.

AZP2006 is a novel treatment that targets the root causes of neurodegeneration by activating a protein crucial for brain function, Progranulin. It has demonstrated a strong safety profile and potential efficacy in human trials involving healthy subjects and PSP patients. ALZPROTECT intends to initiate a Phase 2b/3 proof of concept trial for PSP and plans to extend its drug development to other conditions such as Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis in the near future.