KeifeRx Receives FDA Acceptance of Investigational New Drug for Phase 3 Study of Nilotinib BE in Early Alzheimer's Disease
The Multi-Center Phase 3 Trial is on track to begin enrollment by year-end 2021
WASHINGTON, July 20, 2021 /PRNewswire/ -- KeifeRx, LLC, an emerging clinical-stage biotechnology company specializing in the discovery and development of new treatment options for neurodegenerative diseases, announced today that the company received an acceptance of its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to launch a Phase 3 trial named NILEAD for Nilotinib BE.
The safety and efficacy of a Nilotinib BE will be investigated in individuals with dementia due to Alzheimer's disease with abnormal levels of brain amyloid and supporting clinical diagnosis of early Alzheimer's disease. "We are very pleased that KeifeRx's first IND has been accepted by the FDA" said Charbel Moussa, MBBS, PhD, Co-Founder and Director of KeifeRx's Scientific Advisory Board. "Our Phase 3 study provides us the opportunity to gain valuable insights about the potential effectiveness of Nilotinib BE in treating early Alzheimer's.
"We are excited about this major milestone for KeifeRx, and the chance to demonstrate the capabilities of our tyrosine kinase inhibitors (TKI) platform in neurodegeneration," said Chris Hoyt, CEO of KeifeRx. "We are looking forward to the successful execution of this program and the ability to help people affected by such a debilitating disease."
Alzheimer's disease is a disorder that affects over 6 million people in the United States and more than 44 million people worldwide.
KeifeRx will launch a national, multicenter, placebo-controlled, double-blind study of Nilotinib BE in early Alzheimer's disease. A total of 1275 patients will be randomized into three groups (1:1:1) in which they will receive placebo or one of two doses of Nilotinib BE for 72 weeks. The primary objectives of the study are to investigate the safety and efficacy of Nilotinib BE on the progression of dementia in early Alzheimer's disease. A biomarker sub-study will investigate the effects of Nilotinib BE on amyloid brain burden as well as other makers of Alzheimer's pathology.
KeifeRx is clinical-stage life sciences company that focuses on a family of drugs called tyrosine kinase inhibitors (TKIs) that trigger degradation of malfunctioning proteins, mitigating their pathological toxic effects. KeifeRx was founded in 2019 to redefine the treatment experience for patients suffering from neurodegenerative diseases and movement disorders which include but are not limited to, Alzheimer's Disease, Lewy Body Dementia and Parkinson's Disease. KeifeRx is a DMV Angels backed company.