Tiziana Reports Reduction in Brain Inflammation in Third Multiple System Atrophy Patient Treated with Intranasal Foralumab
Rhea-AI Summary
Tiziana Life Sciences (Nasdaq: TLSA) reported quantitative PET imaging results from the third Multiple System Atrophy (MSA) patient to complete dosing in its Phase 2 trial of intranasal foralumab. PET analysis showed up to a 34% reduction in standardized uptake value (SUV) and 26% reduction in standardized uptake value ratio (SUVR) in disease-relevant brain regions, including the basal ganglia and cerebellar white matter.
According to Tiziana, these reductions are similar to those seen in the first two MSA patients, who demonstrated up to approximately 35% SUV and 24% SUVR reductions, supporting PET imaging evidence of biological activity in dampening neuroinflammation. The company plans to treat additional MSA patients and continues parallel development of intranasal foralumab in non-active secondary progressive multiple sclerosis through an expanded access program and a Phase 2a randomized trial.
Positive
- Third MSA patient PET results up to 34% SUV and 26% SUVR reduction in key brain regions
- Consistent PET reductions across first three MSA patients, with prior data showing ~35% SUV and 24% SUVR decreases
- 14 na-SPMS patients in expanded access program showed improvement or stability within 6 months, per Tiziana
- Phase 2a randomized trial of intranasal foralumab ongoing in non-active secondary progressive multiple sclerosis
- Only fully human anti-CD3 mAb currently in clinical development, according to Tiziana
- Favorable safety profile and clinical responses reported to date for intranasal foralumab, per the company
Negative
- MSA PET data currently based on only three patients who have completed dosing
- Further validation needed, with correlation to clinical features and additional quantitative techniques recommended
- No approved disease-modifying treatments currently exist for MSA, underscoring ongoing unmet need and development risk
News Explained
The third MSA patient completed dosing, but the reported up-to-34% SUV and 26% SUVR reductions are PET imaging findings; the release says their relationship to clinical features and confirmation with additional quantitative techniques remain to be established.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 22 | Insider share purchase | Positive | -5.5% | Executive chairman purchased shares, but the stock declined over the following 24 hours. |
| Jun 25 | Phase 2 dosing update | Positive | +0.9% | The last patient received a first dose in the INFORM-MS Phase 2a trial. |
| Jun 15 | Insider share purchase | Positive | +0.9% | Executive chairman purchased additional shares through Panetta Partners Limited. |
| May 28 | Healthcare conference presentation | Neutral | -0.7% | Management scheduled a corporate presentation covering clinical and corporate updates. |
| May 21 | Phase 2 enrollment update | Positive | -9.3% | The INFORM-MS placebo-controlled Phase 2a trial reached full enrollment. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
TLSA showed mixed reactions to prior company announcements, including two positive clinical or insider events followed by negative moves.
Key Terms
pet imaging technical
standardized uptake value medical
standardized uptake value ratio medical
anti-CD3 monoclonal antibody medical
mucosal tolerance medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
BOSTON, July 31, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces quantitative PET imaging results from the third patient with Multiple System Atrophy (MSA) in the Phase 2 clinical trial treated with intranasal foralumab to complete dosing.
Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. The third MSA patient to complete dosing has shown up to
“The consistency of these PET findings across MSA patients, based on our lab’s approaches, remains encouraging,” said Tarun Singhal, MBBS, M.D.,M.B.A., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Mass General Brigham and Associate Professor of Neurology at Harvard Medical School. “In this third patient to complete dosing, we again saw quantitative reductions similar to those previously seen in the first two patients and reinforce the PET imaging evidence supporting biological activity of intranasal foralumab in dampening neuroinflammation in this devastating disease. Correlation with clinical features and further confirmation with additional quantitative techniques should be performed.”
Figure 1: PET Scan of MSA Patient Treated with Intranasal Foralumab
“Seeing reproducible reductions in neuroinflammation on PET imaging in a third MSA patient further strengthens our confidence in the potential of intranasal foralumab,” said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. “These data build directly on the positive signals already observed in the first two MSA patients, as well as in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease. We remain committed to advancing this program for patients who currently have no approved disease modifying options.”
PET imaging comparisons conducted before and after treatment demonstrated marked reductions in radiotracer uptake across disease-relevant brain regions. These findings suggest a reduction in neuroinflammatory activity following administration of intranasal foralumab.
Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system through mucosal tolerance mechanisms and reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies.
MSA is a rare, progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. There are currently no approved disease-modifying treatments for the condition.
Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these findings and better characterize the therapy’s potential to reduce neuroinflammation in MSA.
About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biologic candidate that has been shown to stimulate T regulatory cells when dosed intranasally. Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2],[3]
About Tiziana Life Sciences
Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information about Tiziana and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Tiziana's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Tiziana's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. Tiziana cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of Tiziana only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Tiziana will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
[3] https://www.neurology.org/doi/10.1212/NXI.0000000000200543
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/30ec9a73-e4a3-4339-a898-67df1b9ad427
