FDA Greenlights Phase 2a Trial of Intranasal Foralumab in Multiple System Atrophy
The Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application, permitting the evaluation of treatment with intranasal foralumab (Tiziana Life Sciences, New York, NY) for people with multiple system atrophy (MSA) in a phase 2a clinical trial (NCT06868628). MSA is a rare, rapidly progressive neurodegenerative disorder with no FDA-approved therapies. The 6-month, open-label study will evaluate the effects of treatment with intranasal foralumab on microglial activation, clinical outcomes, and safety in individuals with MSA.
Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) that targets T-cell–mediated neuroinflammation. Delivered intranasally, the drug is designed to stimulate regulatory T cells and, according to a statement from Tiziana Life Sciences, reduce microglial activation, potentially slowing neuronal damage without systemic immune suppression. In the phase 2a clinical trial, intranasal foralumab will be administered by nasal spray in 8 dose cycles of 3 weeks each. Foralumab is also being studied in an open-label Expanded Access Program (EAP) for multiple sclerosis (MS; NCT06802328), where it has demonstrated disease improvement or stability at 6 months in all 10 current participants, with another ongoing phase 2 trial for people with non-active secondary progressive MS (SPMS; NCT06292923).link to other practical neurology news on these topics?
The planned phase 2a clinical trial that will investigate intranasal foralumab as a treatment for people with MSA is a 6-month, open-label study, which will evaluate changes in the total score on the International Parkinson and Movement Disorder Society—Unified Multiple System Atrophy Rating Scale (MDS-UMSARS) and changes in translocator protein (TSPO) activity as primary end points.
“Neuroinflammation plays a significant role in MSA’s rapid progression. Intranasal foralumab offers a novel therapeutic pathway by targeting T-cell mediated immune activation in the brain,” said Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair in Neurology, Division Chief of Movement Disorders, and Director of the MSA Center of Excellence at Brigham and Women’s Hospital and Principal Investigator of the phase 2a clinical trial. “We aim to observe whether this therapy can meaningfully impact microglial activity and important clinical outcomes over six months in patients with MSA.”
Source: FDA approves Tiziana Life Sciences phase 2 IND for multiple system atrophy. Tiziana Life Sciences. August 11, 2025. Accessed August 12, 2025. https://www.tizianalifesciences.com/fda-approves-tiziana-life-sciences-phase-2-ind-for-multiple-system-atrophy/