Tiziana Life Sciences announced the initiation of a Phase 2a study of intranasal foralumab in patients with non-active secondary-progressive multiple sclerosis (na-SPMS), with a primary endpoint of change in microglial activation as determined by PET scan. The trial will evaluate 2 doses of foralumab versus placebo and is expected to enroll 18 patients in each arm of the study. The company had announced plans for the trial in March 2023.
Tiziana Chairman and acting CEO Gabriele Cerrone commented, “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. We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease. Currently, there are no FDA approved treatments for na-SPMS.”
Chief Operating Officer and Chief Medical Officer Matthew W. Davis said, “I am very pleased the first patient has been dosed and our team is committed to remaining on track with our milestones. We are poised to accelerate enrollment and anticipate data readout in Q4 2024. I believe the study results will reveal important aspects for optimizing clinical management of na-SPMS, particularly the potential for a reduction in MFIS scores.”
Read the Tiziana Life Sciences press release.
