Tiziana Life Sciences Ltd (NASDAQ:TLSA) has said it plans to file an investigational new drug (IND) application this quarter for the use of intranasal foralumab in the treatment of patients with mild to moderate Alzheimer’s Disease.
“Following the FDA feedback from our protocol and development plans from the August 2022 type ‘B’ Pre-IND meeting, Tiziana plans submit its intranasal foralumab protocol and IND for mild to moderate Alzheimer’s disease in Q2 2023,” Gabriele Cerrone, executive chairman, founder and interim chief executive officer of Tiziana said in a statement.
The biopharma group’s chief medical officer, Dr Matthew W Davis, pointed out that at present, there are no treatments approved by the US Food and Drug Administration (FDA) for Alzheimer’s disease-specific to the neuroinflammation caused microglia activation triggered by amyloid beta plaque.
“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,” Davis explained.
To fund the phase 2a trial, Tiziana is hoping to raise $3 million in non-dilutive funding from what it described as “a prestigious Alzheimer’s foundation”.
“It is my expectation that this funding application will be submitted Q2 2023 with a response expected Q3 2023,” Cerrone said.
Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), has been shown to dampen inflammation in patients with COVID-19, with multiple sclerosis and in healthy normal subjects, and phase 2 trials are expected to start in the third quarter this year in patients with non-active Secondary-progressive multiple sclerosis (SPMS).
Contact the author at jon.hopkins@proactiveinvestors.com