Tiziana Life Sciences Ltd (NASDAQ:TLSA) expects to report initial results from its Phase 2 trial of its investigational therapeutic intranasal foralumab for Alzheimer’s disease in the fall of 2024, neurology expert and chairman of the company’s scientific advisory board Dr Howard Weiner told Bloomberg in a live interview.
Earlier this week, Tiziana announced it has received United States Food and Drug Administration (FDA) Investigational New Drug (IND) approval to advance foralumab for Alzheimer’s, with a Phase 2 trial to be conducted at the Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System.
During the Bloomberg interview, Dr Weiner said the company expects to start screening Alzheimer’s patients for the trial this fall, with the trial expected to begin in early 2024 and initial results to follow in fall 2024.
Enrolled patients will be treated with intranasal foralumab, which Dr. Weiner described as “a nasal spray with no side effects.”
He explained that foralumab has been successful in dampening inflammation in the brain, which is also being investigated in patients with Multiple Sclerosis (MS).
“For our MS patients we’ve been treating with foralumab, some of them are walking better and have less fatigue. Some of their neurologic symptoms are reversed,” Dr Weiner said in the interview.
“A win here would be not only slowing progression [of Alzheimer’s] but actually an improvement in cognition. Of course, we’ll be testing that.”
Tiziana CEO Gabriele Cerrone commented in a statement: “Dr Weiner's discussion on Bloomberg offers a glimpse into the potential game-changing solutions in neuroinflammation that Tiziana is pursuing, not only in Alzheimer’s but also in our upcoming Phase 2 trial in non-active secondary progressive multiple sclerosis which will begin shortly this year.”
Dr. Weiner's interview with Bloomberg can be found here.
Shares of Tiziana have added about 17.3% at US$0.75 in the last five trading days.
Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
The company’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date.
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