Tiziana Life Sciences Ltd (NASDAQ:TLSA) has requested its multiple sclerosis treatment be granted orphan drug designation by the Food and Drug Administration (FDA).
Tiziana’s intranasal foralumab would be the first to receive the designation for non-active secondary progressive multiple sclerosis were it to be approved, the biotechnology firm said on Monday.
Such orphan drug designation is granted for treatments of rare diseases or conditions which affect fewer than 200,000 people in the US, chairman Gabriele Cerrone explained.
“Orphan drug designation allows for up to seven years of marketing exclusivity [...] as well as providing the opportunity for other financial incentives to assist with development,” he said.
“It therefore carries significant value to our company and shareholders.”
Foralumab, which stimulates T regulatory cells, has been shown to improve or stabilize all patients in Tiziana’s trials, with 70% becoming less fatigued after six months.
Some 10 patients have been dosed in Tiziana’s expanded access programme so far, with the FDA allowing an additional 20 patients onto the scheme recently.
Data from phase two trials is planned for release next year, the company said, with the FDA set to review Tiziana’s application within 90 days.