Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with Foralumab
Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has granted approval for the use of intranasal foralumab in treating a patient with moderate Alzheimer's disease under an Expanded Access IND. This pathway allows patients with serious conditions, lacking other therapy options, to access investigational drugs. Dr. Howard L. Weiner, Principal Investigator and Chairman of Tiziana’s Scientific Advisory Board, expressed optimism about the potential of nasal foralumab to slow cognitive decline, citing its effectiveness in reducing microglial inflammation in progressive MS patients. The company plans to closely monitor treatment responses while preparing for a Phase 2 study targeting early symptomatic Alzheimer’s disease. Gabriele Cerrone, Chairman and acting CEO, emphasized the groundbreaking potential of foralumab in addressing neuroinflammation caused by toxic protein accumulation in the brain.
- FDA approval for the use of intranasal foralumab in treating a patient with moderate Alzheimer's disease.
- Potential for nasal foralumab to slow cognitive decline in Alzheimer's patients.
- Initiation of a Phase 2 study for early symptomatic Alzheimer's disease.
- to a single patient under Expanded Access IND, indicating early-stage data and potential risks.
Insights
Tiziana Life Sciences' FDA clearance for using intranasal foralumab in patients with moderate Alzheimer's disease represents a significant milestone. Foralumab's potential to slow cognitive decline by dampening microglial inflammation could offer new hope for Alzheimer’s patients, who currently have limited treatment options. By employing an expanded access IND, Tiziana can treat patients outside of traditional clinical trials, providing them with access to this investigational drug sooner. This is particularly valuable for those who have not benefited from existing therapies, including newly approved anti-amyloid drugs.
The mechanism of action for nasal foralumab is noteworthy. Unlike traditional treatments that target amyloid plaques, foralumab focuses on reducing neuroinflammation, a contributing factor in Alzheimer’s pathology. This distinction may lead to different treatment effects and potentially improved outcomes. Moreover, the intranasal route of administration could enhance patient compliance and drug efficiency, as it offers a less invasive and more direct pathway to the brain.
From a research perspective, initiating treatment under the expanded access IND will provide data on the drug's effectiveness and safety in a real-world setting. These insights will be important as Tiziana moves forward with its Phase 2 study. If successful, foralumab could alter the current treatment landscape for moderate Alzheimer’s disease.
The announcement by Tiziana Life Sciences is potentially very positive for the company’s financial outlook. FDA clearance for expanded access IND often signals regulatory confidence in the drug's safety profile, which can positively influence investor sentiment. As foralumab progresses through clinical stages, any positive data could significantly boost Tiziana’s market valuation.
Moreover, Alzheimer's disease represents a substantial market opportunity. With increasing global prevalence, effective treatments are in high demand. If foralumab proves effective, Tiziana could capture a share of this lucrative market. The potential to treat moderate cases, where current therapeutic options are lacking, adds a unique selling point.
Investors should also consider the inherent risks. Early-stage biotech investments are typically high risk-high reward. While the expanded access provides early real-world data, clinical trial results remain paramount. Any negative outcomes could adversely affect the stock. However, the fact that Tiziana has both early symptomatic and moderate Alzheimer’s disease studies underway diversifies their clinical development risk.
NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.
Howard L. Weiner, M.D., Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham healthcare system stated, “I am excited to treat this first patient with moderate AD with nasal foralumab as early as July. These patients have no other treatment options including newly approved anti-amyloid drugs and continue to deteriorate. Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient. We will work closely with FDA to evaluate the treatment responses in this patient with moderate AD while we initiate our Phase 2 study Alzheimer’s Disease in patients with early symptomatic disease.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “In addition to our previously announced IND clearance of the Phase 2a early symptomatic Alzheimer’s Disease study, this additional FDA clearance allows Tiziana to also study intranasal foralumab in patients with moderate Alzheimer’s Disease who do not qualify for approved therapies.” Gabriele Cerrone further commented, “Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.”
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 (NCT06292923) began screening patients in November 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.
For more information please visit our website: www.tizianalifesciences.com
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
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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