Tiziana Life Sciences Ltd (NASDAQ:TLSA) has completed enrollment in its Phase 2 clinical trial evaluating foralumab for secondary progressive multiple sclerosis (SPMS), while also reporting expanded access study data suggesting the investigational therapy may deliver clinically meaningful benefits for patients.
Speaking with Proactive, CEO Ivor Elrifi said the placebo-controlled study has fully enrolled 48 participants across several leading US institutions, including Harvard, Yale, Cornell, Johns Hopkins, UMass Buffalo and Thomas Jefferson.
Topline data are expected by the end of September or early October, following the three-month treatment period and subsequent analysis.
The newly released expanded access data, which includes patients treated for as long as three years, indicated that foralumab's reductions in neuroinflammation may also correlate with improvements in disability progression and fatigue. Elrifi described fatigue as a hallmark of secondary progressive MS and said improvements in this area could materially improve patient quality of life. Most treated patients reportedly achieved improvements on the Modified Fatigue Impact Scale above the threshold considered clinically meaningful.
Elrifi acknowledged the expanded access study was not powered for statistical significance, but said the findings reinforce confidence heading into the controlled trial. The company also compared its data against published results from Sanofi's tolebrutinib program and said foralumab appeared to demonstrate stronger trends across disability-related events and fatigue measures.
Elfiri noted that tolebrutinib was not approved by the FDA due to severe liver safety concerns and only modest efficacy, adding: "So right now we're the front runner, we think, in treating this type of MS."
The upcoming readout could represent a major catalyst for the company. Several pharmaceutical groups have already expressed interest in the program, with some said to want to be "first in line" to review the topline data.
Tiziana also plans to present findings at the joint ACTRIMS-ECTRIMS conference in Toronto later this year.