By David Willey, Benzinga
There have been several accelerated approvals granted to treatments for patients with Alzheimer’s disease (AD) by the Food and Drug Administration (FDA) in recent months, and there are several treatments also in development. Tiziana Life Sciences (NASDAQ: TLSA), a biotechnology company with a robust pipeline of therapies, is looking to bring a novel therapy to market that would tackle neuroinflammation in patients with AD.
In 2021, the FDA granted accelerated approval to Aducanumab, developed by Biogen Inc. (NASDAQ: BIIB), and early in 2023, it gave accelerated approval to Lecanemab, developed by Eisai Co Ltd (TYO: 4523) and Biogen. Both immunotherapies target the disease pathology by reducing amyloid plaque buildup in the brain. While Lecanemab does slow the rate of cognitive decline, it includes the risk of adverse events, and Aducanumab was denied authorization by the European Medical Agency, partly because of fears of side effects like swelling in the brain.
A couple of other treatments are currently in development for treating AD, including Eli Lilly’s (NYSE: LLY) Donanemab, which expects a decision from the FDA by the end of the year, and Acumen Pharmaceuticals’ (NASDAQ: ABOS) ACU193, which has announced safety and efficacy results from its phase 1 trial.
Tiziana Focusing On Neuroinflammation For AD
While these drugs target amyloid, none of them are focused on reducing neural inflammation. However, neuroinflammation is a key indicator for AD, caused by microglia – the primary immune cells of the brain – that are activated by the buildup of amyloid plaque. Targeting neuroinflammation has the potential to be a successful therapeutic strategy for tackling mild to moderate AD.
An investigational new drug (IND) application has filed for Foralumab, a treatment that dampens neuroinflammation by binding to T-cells. “There are no FDA-approved treatments for Alzheimer’s disease specific to the neuroinflammation caused by microglia activation triggered by amyloid beta plaque,” said Matthew W. Davis, the Chief Medical Officer of Tiziana. “We plan to study 3-months administration of intranasal foralumab in Alzheimer’s disease patients to see if neuroinflammatory activated microglia will return to the baseline homeostatic state.”
The company has already seen positive results with foralumab in a trial for indications against multiple sclerosis. Because this drug has already undergone a phase 1 trial, Tiziana may now potentially be able to fast-track foralumab as a treatment for AD. It has applied for a $3 million grant from a prestigious Alzheimer’s research foundation to support a potential phase 2a trial.
If it is granted approval, Tiziana’s drug could provide a novel treatment for patients with mild to moderate AD. The Alzheimer's therapeutics market was worth $5 billion in 2022 and is expected to reach $18 billion by 2029, at a compound annual growth rate (CAGR) of 19% over 2022-2029.
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