Tiziana Life Sciences reported that investigators from Brigham and Women’s Hospital presented new biomarker data from an expanded‑access program for its intranasal anti‑CD3 antibody, foralumab, in patients with non‑active secondary progressive multiple sclerosis (na‑SPMS). The poster, shown at a scientific meeting, detailed results from 10 patients who received the nasal treatment and were monitored for up to six months.
The study used [F‑18]PBR06‑PET imaging to measure microglial activation and cerebrospinal fluid (CSF) proteomics to assess inflammatory and neuroprotective proteins. By the three‑month mark, the PET signal had declined in a statistically meaningful way, and the CSF profile showed reduced inflammatory proteins and increased neuroprotective proteins, indicating that foralumab may dampen harmful CNS inflammation while promoting neuroprotection.
These biomarker results reinforce the mechanistic rationale for Tiziana’s ongoing Phase 2a, randomized, double‑blind, placebo‑controlled trial (NCT06292923) in na‑SPMS, for which top‑line data are expected in the first half of 2026. The data suggest that intranasal delivery can achieve central nervous system exposure sufficient to modulate microglial activity, a key driver of disease progression in SPMS.
In addition to na‑SPMS, the company is evaluating foralumab in other neuroinflammatory indications, including multiple system atrophy, Alzheimer’s disease, and amyotrophic lateral sclerosis. The expanded‑access program (NCT06802328) enrolled 14 patients, with 10 showing disease improvement or stability within six months, providing real‑world evidence that supports the drug’s safety and tolerability profile.
Dr. Tarun Singhal, lead author and neurologist at Brigham and Women’s Hospital, noted that the integrated imaging and proteomic results “demonstrate that [F‑18]PBR06‑PET is biologically tied to the inflammatory and neurodegenerative processes driving progression in SPMS, and that CSF proteomics can serve as a practical biomarker of therapeutic response.” Dr. Howard L. Weiner, chairman of Tiziana’s scientific advisory board, added that the data “strengthen the mechanistic rationale for our ongoing Phase 2 program and offer new tools to monitor disease modification in progressive MS.”
The positive biomarker findings position foralumab as a differentiated therapeutic candidate that could address an unmet need in progressive MS, a field where few disease‑modifying options exist. If the Phase 2a trial confirms clinical benefit, the company could advance to a pivotal Phase 3 study, potentially opening a new revenue stream in a market valued at billions of dollars.
The company’s focus on intranasal delivery is intended to reduce systemic immunosuppression while delivering therapeutic concentrations to the central nervous system. The biomarker data provide early evidence that this approach can modulate microglial activation, a target that has been challenging for other therapies.
With top‑line data from the Phase 2a trial expected in the first half of 2026, investors and stakeholders will be watching to see whether the biomarker signals translate into clinical efficacy and whether the safety profile remains favorable in a larger cohort.
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