Tiziana Life Sciences Ltd (NASDAQ:TLSA) chief medical officer and chief operating officer Matthew Davis speaks to Thomas Warner from Proactive after announcing that Tiziana has received FDA clearance to investigate Foralumab as a potential treatment for Alzheimer's disease.
Davis says that the news marks a significant milestone for both the company and for Alzheimer's treatment at large, going on to say that the drug will be assessed for efficacy in patients with existing FDA approvals and as a standalone therapy for mild to moderate Alzheimer's cases.
The green light from the FDA comes after extensive groundwork, building on the success of Tiziana's work in multiple sclerosis, and Davis highlights the wealth of patient safety data and preclinical evidence that bolstered the FDA's decision.
With the regulatory hurdle crossed, clinical trials are set to commence in collaboration with Brigham and Women's Hospital.
Davis acknowledges the vast potential of the Alzheimer's market, which remains underserved. He emphasises the unique approach of Foralumab as the only fully human anti-CD3, which sets it apart from existing treatments.
While precise timelines haven't been disclosed, Davis anticipates concrete developments within the next two quarters.
He also assures audiences of Tiziana's continued commitment to multiple sclerosis research, with an investigator meeting and dosing of the first patient anticipated by year-end.