Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that the first patient has been dosed in its Phase 2a study which is comparing two doses of its investigational therapeutic intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS).
The trial involves six investigational centers which will recruit up to 18 patients per treatment arm.
The primary endpoint will be change in change in microglial activation based on PET scans with other evaluations to include the Expanded Disability Status Scale, Quality of Life (QoL) assessments, and the Modified Fatigue Impact Scale.
The company said it is poised to accelerate enrollment in the trial and expects data readout in the fourth quarter of 2024.
“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,” Tiziana Life Sciences CEO Gabriele Cerrone commented.
“We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease.”
Principal Investigator at Brigham at Women’s Hospital Dr. Tanuja Chitnis added: “My anticipation is this randomized placebo-controlled trial is the first step in bringing this potential treatment to patients that have na-SPMS, a disease with no approved therapy.”
Shares of Tiziana traded higher on the news, up 4.5% at US$0.58 in premarket trade on Tuesday.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Its lead drug candidate intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date.