Tiziana Life Sciences shares shoot up after receiving FDA sign-off for use nasally administered monoclonal antibody to treat a person with secondary progressive multiple sclerosis

Shares in Tiziana Life Sciences plc (NASDAQ:TLSA, LON:TILS) shot up 20% after it announced the US regulator has approved the use of its nasally administered monoclonal antibody to treat a person with secondary progressive multiple sclerosis (SPMS). Foralumab will be provided under the Food & Drug Administration’s individual patient expanded access protocol overseen by researchers at the Brigham and Women's Hospital (BWH), Harvard. This is the first time a nasally administered antibody will be given to a patient with SPMS. Sufferers of multiple sclerosis have limited treatment options with Tysabri, sold by Biogen Inc (NASDAQ:BIIB), one of the few drugs offering relief. Tiziana’s treatment programme is planned to start in the second quarter and will continue for six months. Safe and well-tolerated The drug developer previously completed a phase I trial of nasally administered Foralumab, which showed it to be well-tolerated with no drug-related safety issues. Nasal foralumab was developed by Howard Weiner, chairman of Tiziana’s scientific advisory board and a professor at BWH. "Nasal anti-CD3 is an exciting, novel approach that has the ability to provide a safe treatment for a form of MS that has no effective treatment,” he said. “We are pleased that the FDA has allowed us to treat a patient with SPMS who needs a better treatment option than is currently available." Covid trial moves forward Earlier, Tiziana said it is taking its versatile treatment into phase II clinical trials in people with moderate to severe Coronavirus (COVID-19). This follows an earlier study in Brazil, which showed evidence that Foralumab reduced pulmonary and systemic inflammation and was well tolerated. Nasally-administered Foralumab is thought to work by improving the immune system by stimulating the body’s regulatory T cells. It is also believed to dampen harmful T cell responses in the nasal and respiratory tract, the primary sites of the COVID-19 virus.