FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis
Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has accepted its submission for Fast Track Designation for its intranasal foralumab treatment for non-active, secondary-progressive multiple sclerosis (na-SPMS). Foralumab is a fully human anti-CD3 monoclonal antibody designed to induce T regulatory cells. In an Intermediate-Sized Patient Population Expanded Access program, 70% of the ten dosed patients demonstrated a clinically meaningful reduction in fatigue, with disease stability observed over six months. The Fast Track submission included data from both animal models and clinical experience. If granted, this designation could expedite FDA review processes, which is significant given the lack of approved therapies for na-SPMS. Chairman and acting CEO Gabriele Cerrone highlighted the potential of Fast Track Designation to enhance development through increased FDA interaction and partnership.
- FDA acceptance of Fast Track Designation submission for intranasal foralumab for na-SPMS.
- Foralumab demonstrated a 70% reduction in fatigue scores among patients in an ISPPEA program.
- All patients showed disease stability over six months in the ISPPEA program.
- Foralumab would be the only intranasal monoclonal antibody for multiple sclerosis if approved.
- Fast Track Designation could expedite the FDA review process for foralumab.
- Only ten patients have been dosed in the ISPPEA program, which is a very small sample size.
- The Fast Track Designation has not yet been granted, only the submission was accepted.
Insights
The acceptance of Tiziana Life Sciences' submission for Fast Track Designation by the FDA is a significant milestone. This designation is designed to expedite the development and review of drugs that treat serious conditions with unmet medical needs. For non-active secondary-progressive multiple sclerosis (na-SPMS), there are currently no FDA-approved therapies. This highlights the potential market opportunity for intranasal foralumab, if it eventually gains approval.
Foralumab’s unique delivery method, intranasal administration, distinguishes it from other monoclonal antibodies which require intravenous or subcutaneous routes. This could potentially offer a less invasive and more patient-friendly option, improving patient adherence and quality of life.
The initial results from the Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program are promising, with 70% of patients showing clinically meaningful reductions in fatigue scores and all patients maintaining disease stability over six months. However, investors should note that these results are preliminary and based on a small cohort. The ongoing Phase 2a trial will provide more robust data to evaluate efficacy and safety.
In summary, the Fast Track Designation submission acceptance could positively impact Tiziana Life Sciences by accelerating the development timeline, providing additional FDA guidance and potentially shortening the time to market, which is beneficial for patients and shareholders alike. However, it is important to remain cautious until larger, more definitive studies confirm the early promising findings.
From a financial perspective, the acceptance of Tiziana Life Sciences' submission for Fast Track Designation by the FDA could lead to enhanced investor confidence and potential stock price appreciation. This designation can expedite the drug development process, reducing the time and resources needed to bring Foralumab to market. This can significantly impact the company's financials, reducing development costs and time to revenue realization.
The potential to address an unmet medical need in the na-SPMS market offers a substantial revenue opportunity. With no current FDA-approved therapies for na-SPMS, Foralumab could capture a significant market share upon approval. The unique intranasal delivery could further differentiate the product and enhance its market appeal.
However, investors should be aware of the inherent risks associated with biopharmaceutical development, including the possibility of setbacks in clinical trials and regulatory hurdles. While the Fast Track Designation offers potential benefits, it does not guarantee eventual approval. The company's financial health also depends on other factors, including its pipeline diversity, cash flow management and strategic partnerships.
Overall, the news augurs well for Tiziana Life Sciences. Still, prudent investors should keep an eye on upcoming trial results and regulatory updates to make informed decisions.
NEW YORK, June 11, 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 it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate shown to cause T regulatory (Treg) cell induction when dosed intranasally. At present, ten (10) na-SPMS patients have been dosed in an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program with clinically meaningful reduction in fatigue scores (MFIS) in
“Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation. The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted,” he added.
About FDA Fast Track Designation
At this stage of development, a drug that receives Fast Track designation is eligible for some or all of the following[1]:
- More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
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.[2],[3]
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.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
[2] https://www.pnas.org/doi/10.1073/pnas.2220272120
[3] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
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