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

2024-03-13

临床2期临床1期

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. This press release features multimedia. View the full release here: 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 pro 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. View source version on businesswire.com: Contacts p.verwaerde@alzprotect.com Source: Alzprotect Smart Multimedia Gallery Video Alzprotect's corporate video Logo View this news release online at:

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构