First patient dosed in phase 2a study of intranasal MS treatment

A biotechnology company announced the first patient was dosed in its phase 2a clinical trial of intranasal foralumab, a monoclonal antibody treatment for those with non-active secondary-progressive multiple sclerosis.

According to a release from Tiziana Life Sciences Ltd., foralumab is an anti-CD3 monoclonal antibody that binds to the T-cell receptor and dampens inflammation by modulating T-cell function, an effect previously observed in those with COVID-19 and MS, and in healthy study participants.

Six investigational centers have been selected for the double-blind, placebo-controlled trial, with up to 18 individuals enrolled per treatment arm. The trial’s primary endpoint will be change in microglial activation based on PET scans, according to the release. In addition, novel immuno-biomarkers will be measured and assessed for predictive relevance.

Clinical evaluations within the study include the Expanded Disability Status Scale (EDSS), quality of life assessments and the Modified Fatigue Impact Scale (MFIS), which evaluate parameters that are essential to everyday life of patients, per the release.

“I believe that our dosing of the first patient confirms Tiziana’s ability to execute on its commitments and potential to advance our fully human intranasal anti-CD3 mAb, foralumab, using novel imaging methods and clinically relevant endpoints,” Gabriele Cerrone, chairman, acting CEO and founder of Tiziana Life Sciences, said in the release. “We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease.”