Tiziana Life Sciences Ltd shares rose by 22% after it announced positive clinical data from a person with secondary progressive multiple sclerosis receiving the drug developer’s nasally administered monoclonal antibody treatment.
Signs of efficacy were detected, while Tiziana’s Foralumab was well tolerated and there were no adverse effects in the six months of therapy, which will be continued.
Based on these observations, the US Food & Drug Administration has allowed a second patient to receive the drug under a separate single-patient expanded access investigational new drug application.
“We are very excited about the positive clinical data reported today demonstrating the potential of intranasally administered immunotherapy with foralumab for treatment of SPMS and other neurodegenerative diseases,” said Tiziana chief executive, Dr Kunwar Shailubhai in a statement.
READ: Tiziana Life Sciences given nod for second patient to undergo multiple sclerosis treatment
“Importantly, data from this patient serve as the first validation of our breakthrough and potentially transformational approach with a convenient, intranasal ‘take home’ immunotherapy for SPMS and other neurological diseases. Today’s news marks an important first step toward advancing our platform using alternative, novel routes of immunotherapies to provide local rather than systemic delivery of antibodies," he added.
Using advanced imaging, the team at the Brigham and Women’s Hospital (BWH), Harvard, was able to detect a sustained inhibition of certain key drivers of MS, such as microglia, while stabilization of disease was picked by via clinical assessments.
Established MS drugs such as Tysabri, made by Biogen Inc (NASDAQ:BIIB), Johnson & Johnson (NYSE:JNJ)’s Mayzent and Zeposia, from Bristol Myers Squibb Co, are known to supress microglial activation.
“The potential for intranasally administered foralumab to suppress microglial activation is a novel and well-tolerated immunologic approach to potentially treat SPMS, a form of MS that currently has no effective treatment,” said Howard Weiner, director of the MS Program at BWH and chairman of Tiziana’s scientific advisory board.
Contact the author at ian.lyall@proactiveinvestors.com