KeifeRx Receives FDA Acceptance of Investigational New Drug for Alzheimer's Disease

KeifeRx, LLC, an emerging clinical-stage biotechnology company specializing in the discovery and development of new treatment options for neurodegenerative diseases, announced that the company received an acceptance of its Investigational New Drug (IND) application from the US 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, Associate Professor at Georgetown University and 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.