EMA and FDA Endorse Alzprotect's PSP Phase 2b/3 Plan

ALZPROTECT has achieved a major milestone with the positive reception from both FDA and EMA on the clinical progression of Ezeprogind/AZP2006 for progressive supranuclear palsy (PSP) patients. The favorable feedback is a significant boost following the phase 2a study's promising results, indicating a clear path for future development in line with scientific and regulatory standards.

The regulatory bodies have offered essential guidance on the study's design, emphasizing the selection of endpoints that are relevant to PSP and ensuring the study's demographic reflects the global PSP patient population. This advice has equipped ALZPROTECT with a strategic plan to refine the Phase 2/3 study protocol, ensuring it meets scientific rigor and regulatory compliance. With a clear regulatory path, ALZPROTECT is gearing up for the Proof of Concept randomized controlled PROMISE-PSP trial, expected to start by the end of 2024, aiming to meet the expectations of both the U.S. and the EU.

Dr. Artin Karapet, Chief Medical Officer at ALZPROTECT, expressed his enthusiasm for the consensus reached among regulatory bodies, noting that their guidance is not only practical but also brings the treatment closer to the patient community. Phil Verwaerde, CEO of ALZPROTECT, emphasized the importance of this alignment with regulatory authorities, stating that it validates their vision and the potential of Ezeprogind/AZP2006 for PSP and other neurodegenerative diseases. He also highlighted the company's commitment to accelerating efforts to address the urgent needs of patients.

Ezeprogind/AZP2006 is a novel molecule with a unique mechanism that targets the root causes of neurodegeneration by enhancing the activity of a protein crucial for brain function, Progranulin. The drug has demonstrated good safety and efficacy in human trials involving 102 healthy subjects in three Phase I trials and 36 PSP patients in a Phase 2a trial. ALZPROTECT plans to initiate a Phase 2b/3 proof of concept study for PSP and intends to expand its drug development to encompass Parkinson's disease, Alzheimer's disease, and amyotrophic lateral sclerosis in the near future.