Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab in Multiple Sclerosis
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced the dosing of the first patient in its Phase 2a study for intranasal foralumab in patients with non-active secondary-progressive multiple sclerosis (na-SPMS). The trial aims to compare two doses of foralumab and placebo, with a primary endpoint of change in microglial activation based on PET scans. The study also includes assessments of clinical parameters and immuno-biomarkers. The company hopes to provide a new therapeutic option for na-SPMS patients, as there are currently no FDA-approved treatments for this condition.
Tiziana Life Sciences' initiation of a Phase 2a study for foralumab, targeting non-active secondary-progressive multiple sclerosis, signals a pivotal step towards addressing a significant unmet medical need. This trial's primary endpoint focusing on microglial activation is a sophisticated approach to gauge neuroinflammation, a key factor in SPMS progression. The inclusion of clinical evaluations such as EDSS, QoL and MFIS provides a comprehensive assessment of the drug's impact on patients' daily functioning and fatigue levels, which are critical in chronic conditions.
The use of novel immuno-biomarkers and central review of PET scans underscores a commitment to rigorous scientific evaluation. Should the trial demonstrate efficacy and safety, it may pave the way for a novel treatment paradigm in a market currently devoid of FDA-approved options for na-SPMS. Investors should monitor the enrollment progress and data readout, as positive results could significantly impact Tiziana's valuation and provide momentum for the drug's advancement through the regulatory pathway.
The strategic implications of Tiziana Life Sciences' Phase 2a trial commencement for investors are multifaceted. The company's focus on a niche patient population with na-SPMS represents a calculated risk with the potential for high reward, given the absence of approved therapies. The trial's design, leveraging intranasal delivery of foralumab, could offer a differentiated administration route that improves patient compliance and outcomes.
Investors should consider the long-term commercial potential, which hinges not only on clinical efficacy but also on market access, reimbursement and competitive dynamics. A successful trial could lead to partnership opportunities or buyout interest, providing a liquidity event for shareholders. However, the inherent risks of clinical development, including trial delays or negative outcomes, must be weighed against these prospects. Diversification within investment portfolios may mitigate such risks.
The therapeutic potential of foralumab in na-SPMS is underscored by its mechanism of action as an anti-CD3 monoclonal antibody, which could modulate the immune system in a manner that slows disease progression. The trial's focus on microglial activation is a reflection of the evolving understanding of SPMS pathophysiology, where neuroinflammation plays a central role.
For patients, the prospect of a treatment that can be self-administered intranasally would represent a significant improvement in quality of life, reducing the burden of more invasive administration methods. The study's outcomes, particularly in reducing MFIS scores, could signal a breakthrough in symptom management for SPMS, a condition that often leads to increasing disability over time. The medical community will be watching closely, as positive results could revolutionize the standard of care for this patient population.
12/19/2023 - 07:00 AM
NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA ) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS). Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans. Clinical evaluations include the Expanded Disability Status Scale (EDSS), QoL assessments, and the Modified Fatigue Impact Scale (MFIS), which assess parameters that are essential to a patient’s everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study.
"The successful consenting, screening, completion of the baseline PET scan, and dosing of our first patient in the intranasal foralumab Phase 2a trial has occurred seamlessly,” said Tanuja Chitnis, M.D., the Principal Investigator at Brigham and Women’s Hospital, a founding member-hospital of Mass General Brigham Healthcare System, and Professor of Neurology at Harvard Medical School. “My anticipation is this randomized placebo-controlled trial is the first step in bringing this potential treatment to patients that have na-SPMS, a disease with no approved therapy. Our experience in the Expanded Access Program provides sustainable hope for relief of symptoms in these patients with an unmet medical need.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences said, “I believe that our dosing of the first patient confirms Tiziana’s ability to execute on its commitments and potential to advance our fully human intranasal anti-CD3 mAb, foralumab, using novel imaging methods and clinically relevant endpoints. We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease. Currently, there are no FDA approved treatments for na-SPMS.”
Matthew W. Davis, MD, RPh, Chief Operating Officer and Chief Medical Officer of Tiziana, added, “I am very pleased the first patient has been dosed and our team is committed to remaining on track with our milestones. We are poised to accelerate enrollment and anticipate data readout in Q4 2024. I believe the study results will reveal important aspects for optimizing clinical management of na-SPMS - particularly the potential for a reduction in MFIS scores.”
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.
References:
1 https://www.pnas.org/doi/10.1073/pnas.2220272120
2 https://www.pnas.org/doi/10.1073/pnas.2309221120
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 info@tizianalifesciences.com
Investors: ikoffler@lifesciadvisors.com
What is the company name and ticker symbol for the biotechnology company developing neuro-immunomodulation therapies?
Tiziana Life Sciences Ltd. (Nasdaq: TLSA)
What is the purpose of the Phase 2a study announced by Tiziana Life Sciences Ltd.?
The study aims to compare two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS).
What is the primary endpoint of the Phase 2a study?
The primary endpoint is the change in microglial activation based on PET scans.
What assessments are included in the study?
Clinical evaluations include the Expanded Disability Status Scale (EDSS), QoL assessments, and the Modified Fatigue Impact Scale (MFIS), along with novel immuno-biomarkers.
What is the anticipated timeline for data readout from the study?
The company anticipates data readout in Q4 2024.
