Tiziana Life Sciences Announces Updated Clinical and PET Scan Findings for Intranasal Foralumab in Two New Multiple Sclerosis Patients
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Insights
Recent findings from Tiziana Life Sciences Ltd. regarding their neuro-immunomodulation therapies, specifically in patients with non-active secondary progressive multiple sclerosis (na-SPMS), indicate a potential breakthrough in the treatment of this chronic disease. The improvement in fatigue scores and the reduction in microglial activation are significant because microglia play a crucial role in neuroinflammation, which is a hallmark of multiple sclerosis progression. The Modified Fatigue Impact Scale (MFIS) is a validated tool to assess the impact of fatigue on daily functioning and improvements in this scale can be indicative of enhanced quality of life for patients.
The use of positron emission tomography (PET) scans to measure microglial activation provides a quantitative biomarker to evaluate the efficacy of treatments. [F-18] PBR06, the tracer used in the PET scans, is designed to bind to the translocator protein (TSPO) which is expressed by activated microglia. A reduction in the PET signal suggests a decrease in inflammation, which could correlate with clinical improvement. However, it is important to note that while these initial results are promising, they are based on a small sample size and need to be confirmed through larger, controlled clinical trials.
The ongoing Phase 2 trial will be critical to establish the efficacy and safety of intranasal foralumab. This route of administration targets inflammation directly in the brain, which could offer advantages over systemic treatments. The trial's design, a dose-ranging, randomized, placebo-controlled study, is the gold standard for determining a drug's effect. If successful, this could lead to a new therapeutic option for patients with na-SPMS, a condition with limited treatment modalities.
The announcement by Tiziana Life Sciences Ltd. of positive interim clinical data could have a favorable impact on the company's stock performance. Investors often react positively to news of successful clinical trial outcomes, especially in the biotechnology sector where the pipeline's progress is closely tied to the company's valuation. The development of treatments for na-SPMS represents a significant market opportunity due to the chronic nature of the disease and the need for innovative therapies.
However, the financial implications for Tiziana and its investors will depend on the continuation of positive results in the ongoing Phase 2 trial and subsequent studies. Regulatory approvals, market acceptance and the ability to scale production will also be key factors influencing the long-term financial success of the therapy. Moreover, partnerships or licensing agreements could be pursued to mitigate risk and finance further development. It is essential for investors to monitor the progress of the trials and any strategic decisions made by the company in relation to its pipeline.
The therapeutic landscape for multiple sclerosis (MS), particularly secondary progressive MS, is evolving with a focus on neuroprotective and neuroimmunomodulatory therapies. Tiziana's foralumab represents a novel approach in this space, potentially addressing an unmet medical need. The global MS drugs market is expected to grow, driven by the increasing prevalence of the disease and the introduction of new therapies. Tiziana's positive preliminary results could position the company as a noteworthy player in this market.
Market dynamics, such as competitor activities, pricing strategies and reimbursement policies, will influence Tiziana's market penetration. The company's ability to demonstrate clinical benefits, along with a favorable safety profile, will be crucial in differentiating foralumab from other treatments. Additionally, the patient-centric approach of intranasal administration could improve adherence and patient outcomes, further enhancing the drug's market potential. Stakeholders should watch for the outcome of the Phase 2 trial and subsequent regulatory interactions to better assess the market impact of Tiziana's therapy.
NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced positive findings have been seen in a total of six out of eight Intermediate Size Patient Population Expanded Access (EA) patients. These patients have shown improvements in fatigue scores measured by the Modified Fatigue Impact Scale (MFIS). PET scan findings showing a reduction in microglial activation was also seen in the six patients with MFIS score improvement at the three-month evaluation period. PET scan findings for two additional EA patients (10 total) are planned to be available in late January.
Tarun Singhal, M.B.B.S., M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, commented, “Upon review of the baseline and three-month [F-18] PBR06 PET scans of the two new na-SPMS EA patients, a qualitative reduction in microglial activity was seen in one of two new patients. When combined with my assessment of the first six EA patients at three-months, a total of six out of the eight suggested a reduction in qualitative microglial PET signal. These findings are promising from an imaging standpoint and further studies are needed to confirm them using additional quantitative approaches.”
“The EA patient having a qualitative improvement in their PET scan also improved in their Modified Fatigue Impact Scale,” stated Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital. “Six out of the eight na-SPMS EA patients studied so far have seen measurable clinical improvement in their fatigue. I am excited to lead the effort to replicate these findings in the ongoing Phase 2 dose-ranging, randomized, placebo-controlled clinical trial.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences noted “We’ve seen continued clinical and qualitative PET scan improvement over time in patients with na-SPMS where intranasal foralumab targets inflammation in the brain. It is my expectation that we will rapidly progress our ongoing Phase 2 trial of intranasal foralumab, given the encouraging results seen so far under the EA IND."
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial dosed its first patient in December of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.1,2
About Tiziana Life Sciences
Tiziana Life Sciences 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, 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.
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 Company'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 Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company 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, 2022, 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. The Company 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
Investors:
Irina Koffler
LifeSci Advisors, LLC
+1 646 970 4681
ikoffler@lifesciadvisors.com
1 https://www.pnas.org/doi/10.1073/pnas.2220272120
2 https://www.pnas.org/doi/10.1073/pnas.2309221120
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