Tiziana Life Sciences, a biotech company developing immunomodulation therapies, has been granted Fast Track designation from the US Food & Drug Administration (FDA) for its intranasal formulation of foralumab.
The fully human anti-CD3 monoclobal antibody (mAb) will be used to treat secondary progressive multiple sclerosis, and marks a significant milestone for the commercialisation jounrney of this therapeutic.
The fast track designation will accelerate the review process, potentially allowing the quick release of a therapeutic to market for a disease area with significant unmet needs.
This is the fourth fast track designation the FDA has granted in 2024, according to Tiziana.
The fast track status also allows the Tiziana to have more frequent meetings with the FDA to discuss the drug's development plan, as well as its priority review upon submission.
"Receiving Fast Track designation is a testament to the innovative approach we are taking with foralumab," said Dr William Clementi, Chief Development Officer of Tiziana Life Sciences. "We believe that the intranasal delivery method offers a novel way to effectively target neuroinflammation, and we look forward to working closely with the FDA to bring this therapy to patients in need."
Intranasal foralumab is designed to modulate the immune system and reduce neuroinflammation, which is a key factor in the progression of neurodegenerative diseases such as Multiple Sclerosis, Alzheimer’s Disease and Amyotrophic Lateral Sclerosis (ALS).
Early clinical data have shown that intranasal Foralumab can deliver therapeutic benefits with a favourable safety profile. The company aims to accelerate these programs and capitalise on opportunities to address significant unmet medical needs.