KeifeRx Receives FDA Approval of New Investigational Drug for Phase 3 Study of Nilotinib BE in Early Alzheimer’s Disease

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, today announced that the company has received acceptance of its application investigational new drug (IND) from the United States The United States Food and Drug Administration (FDA) will initiate a Phase 3 trial named NILEAD for Nilotinib BE.

The safety and efficacy of a BE Nilotinib will be studied in people with dementia due to Alzheimer’s disease with abnormal levels of cerebral amyloid and supporting the 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 Scientific Advisory Board. “Our phase 3 study offers us the opportunity to gain valuable information on the potential efficacy of Nilotinib BE in the treatment of early-onset Alzheimer’s disease.

“We are excited about this major milestone for KeifeRx and the opportunity to demonstrate the capabilities of our tyrosine kinase (TKI) inhibitor platform in neurodegeneration,” said Chris Hoyt, CEO of KeifeRx. “We look forward to the successful delivery of this program and the ability to help those affected by such a debilitating disease.”

Alzheimer’s disease is a disease that affects more than 6 million people in United States and over 44 million people around the world.

About NILEAD:

KeifeRx will launch a national, multicentre, placebo-controlled, double-blind study of Nilotinib BE in the onset of Alzheimer’s disease. A total of 1275 patients will be randomized into three groups (1: 1: 1) in which they will receive a placebo or one of the two doses of Nilotinib BE for 72 weeks. The main objectives of the study are to study the safety and efficacy of Nilotinib BE on the progression of dementia at the onset of Alzheimer’s disease. A biomarker sub-study will study the effects of nilotinib BE on amyloid brain load as well as on other causes of Alzheimer’s disease.

About KeifeRx:

KeifeRx is a clinical-stage life science company focused on a family of drugs called tyrosine kinase inhibitors (TKIs) that trigger the breakdown of defective proteins, mitigating their pathological toxic effects. KeifeRx was founded in 2019 to redefine the therapeutic experience for patients with neurodegenerative diseases and movement disorders, including Alzheimer’s disease, Lewy body dementia and Parkinson’s disease. KeifeRx is a company backed by DMV Angels.

For more information on KeifeRx, please visit https://www.keiferx.com, https://www.linkedin.com/company/keiferx, or contact: Pasha Jahangiri, 571-294-7167 or 314757 @ email4pr. com.

KeifeRx
1356 Beverly Road, Suite 300
McLean, Virginia 22101

View original content: https://www.prnewswire.com/news-releases/keiferx-receives-fda-acceptance-of-investigational-new-drug-for-phase-3-study-of-nilotinib-be-in – onset-alzheimer-disease-301337231.html

SOURCE KeifeRx

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