Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it has won approval from the US Food and Drug Administration under an Expanded Access IND to dose its first patient with moderate Alzheimer's disease with its investigational therapeutic intranasal foralumab.
Expanded access INDs allow patients to gain access to investigational drugs, biologics and medical devices to treat serious diseases and conditions for which there are no comparable or satisfactory therapy options outside of clinical trials, the biopharmaceutical company said.
It expects to dose its first patient with moderate Alzheimer's as early as July.
“In addition to our previously announced IND clearance of the Phase 2a early symptomatic Alzheimer’s Disease study, this additional FDA clearance allows Tiziana to also study intranasal foralumab in patients with moderate Alzheimer’s disease who do not qualify for approved therapies,” Tiziana CEO Gabriele Cerrone said.
“Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.”
Dr Howard Weiner, chairman of Tizian’s Scientific Advisory Board and principal investigator, highlighted that patients with moderate Alzheimer’s disease have no other treatment options, including newly approved anti-amyloid drugs, and continue to deteriorate.
“Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive Multiple Sclerosis and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient,” Dr Weiner said.
“We will work closely with FDA to evaluate the treatment responses in this patient with moderate Alzheimer’s disease while we initiate our Phase 2 study Alzheimer’s disease in patients with early symptomatic disease.”