Tiziana Life Sciences Ltd (NASDAQ:TLSA) CEO Ivor Elrifi talked with Proactive about a series of important developments for the company, including the dosing of its first patient in an early Alzheimer’s disease Phase 2 trial.
Elrifi explained that the FDA has allowed Tiziana to include both drug-naive patients and those previously treated with anti-amyloid therapies such as Leqembi or donanemab.
The company’s lead candidate, foralumab, is a fully human monoclonal antibody targeting CD3, aimed at reducing neuroinflammation.
Tiziana now has three Phase 2 trials underway—covering secondary progressive multiple sclerosis (SPMS), multiple system atrophy (MSA), and Alzheimer’s—with a fourth in ALS expected to begin in January. All trials aim for topline data readouts in 2026, although the ALS study may extend into early 2027 depending on enrolment.
Proactive: Welcome back inside our Proactive newsroom. And joining me now is Ivor Elrifi. He is the CEO of Tiziana Life Sciences. And Ivor, it's great to see you again. How are you?
Ivor Elrifi: Good. Nice to see you again. Everything was good.
Good. I'm glad to hear that, because the company has some pretty significant news today. I'll let you sort of take it from there because this is a key milestone for the company.
So we have very exciting news across a number of fronts. We are ringing the Nasdaq closing bell today, which is a very proud moment for us. We also dosed our first Alzheimer's patient yesterday. So we now have three Phase 2 trials underway and a fourth one about to begin next month. So, very good headwinds for us right now.
Yeah. Maybe you can sort of talk to us a little bit about those Phase 2s and what you're looking at. And just so people are completely up to date with what the company does.
Sure. So our lead asset is a fully human monoclonal antibody that binds to CD3. It's called foralumab. What we are trying to do is reduce neuroinflammation. Neuroinflammation is common across many neurodegenerative diseases. We have an ongoing Phase 2 trial in secondary progressive multiple sclerosis (SPMS). We're very close to concluding enrollment in that study and expect to have topline data readout in 2026.
We also have a second Phase 2 trial in multiple system atrophy (MSA), for which there is no approved therapy. We expect topline readout in 2026 for that as well. As I just mentioned, we dosed our first patient yesterday in our early Alzheimer’s Phase 2 study, and we expect data readout in 2026. In January, we expect to start our ALS trial, and we're proud of that because we’ve been approved to enter the ALS mismatch program — the preeminent organisation for clinical trial excellence in ALS. It includes four centres and top ALS physicians. We’re very excited about that.
Okay. Just on the dosing of the first patient — that trial is kind of twofold. It’s to see what would happen as a standalone, but also with current care that's out there. Is that right?
Correct. The FDA has permitted us to dose two types of patients in that trial. One is patients who are drug-naive, meaning they’re not on any drug at all. The other group is patients with early Alzheimer’s who have been on an anti-amyloid therapy such as Leqembi or donanemab for six months.
It is our view — and we have data to support this — that patients, even if they’re on an anti-amyloid therapy, still have significant neuroinflammation. So what we hope to see is a reduction in neuroinflammation, along with a reduction in amyloid buildup in those patients.
Yeah. I mentioned this is a key milestone for the company, but it sounds like 2026 is going to be a year with a number of key milestones. Is that what investors should understand about where the company is headed?
Yes, I think that's exactly right. We expect to have topline readouts in three Phase 2 trials next year. SPMS — and let me remind everybody, SPMS is not the same as relapsing-remitting MS. Relapsing-remitting has good therapies. SPMS does not. So there’s a real need. We also have fast track designation from the FDA for that indication.
MSA — there’s no approved therapy. It’s orphan, so we’re going to get fast track and orphan designation from the FDA for that as well. That will also read out in 2026. And the Alzheimer’s trial we just talked about — same timeline. ALS may also read out in 2026, but it could extend into Q1 of 2027 depending on enrollment.
Quotes have been lightly edited for style and clarity