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FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy
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Tiziana Life Sciences, a biotechnology company focused on immunomodulation therapies, has announced that the U.S. Food & Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 2a clinical trial. The study will evaluate the company's lead drug candidate, intranasal foralumab, as a potential treatment for Multiple System Atrophy (MSA). This approval is a critical development for patients with MSA, a rare and life-limiting neurodegenerative disorder for which there are no currently approved therapies.

The Phase 2a trial (ClinicalTrials.gov Identifier: NCT06868628) is a six-month, open-label study designed to assess the effects of intranasal foralumab on microglial activation, as well as on clinical outcomes and patient safety. Foralumab is a fully human anti-CD3 monoclonal antibody administered via nasal spray, with the goal of targeting and modulating the T-cell-mediated neuroinflammation that is believed to be a key driver of MSA's rapid progression. The drug works by inducing regulatory T cells, which help promote immune tolerance and reduce neuronal damage, all while minimizing systemic immune suppression.

MSA is an orphan disease with a poor prognosis, marked by severe disability and a median survival of just 6-9 years after diagnosis. The disorder affects autonomic functions like blood pressure and motor control. Increasing evidence points to neuroinflammation and activated microglia as major contributors to the disease's pathogenesis. The study's primary investigator, Dr. Vikram Khurana, noted that foralumab's novel therapeutic pathway offers a promising approach to slow the disease's progression by directly addressing this neuroinflammatory component.

Tiziana's intranasal delivery method is designed to provide an improvement in efficacy and tolerability compared to traditional intravenous delivery. Foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development.

This drug has also shown promising results in other neuroinflammatory diseases, with a favorable safety profile and clinical responses observed in an Expanded Access Program for patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS). Tiziana's innovative approach and the FDA's acceptance of the IND represent a new and hopeful path for treating patients with MSA.

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