NEW YORK - Tiziana Life Sciences , Ltd. (NASDAQ:TLSA) announced today that its novel intranasal therapy foralumab has been submitted for Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS).
This comes after an ISPPEA Program showed a clinically meaningful reduction in fatigue scores in 70% of na-SPMS patients and disease stability within six months in all participants.
Foralumab is a fully human anti-CD3 monoclonal antibody, which has been shown to induce T regulatory (Treg) cells when administered intranasally. This mode of delivery is unique among monoclonal antibody therapies for multiple sclerosis, which typically require intravenous or subcutaneous administration.
The Fast Track Designation is sought to expedite the review process for drugs targeting serious conditions with unmet medical needs. If granted, it would facilitate more frequent meetings with the FDA and the possibility of Accelerated Approval and Priority Review for foralumab.
The company provided data from both animal models and the ISPPEA program to support its Fast Track request. The ongoing Phase 2a trial, a double-blind randomized, placebo-controlled, multicenter study, is further evaluating the efficacy and safety of intranasal foralumab (NCT06292923).
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, expressed that the Fast Track Designation could significantly benefit the development program for foralumab, acknowledging the serious and progressive nature of na-SPMS and the lack of FDA-approved therapies for this condition.
Tiziana Life Sciences is focused on developing therapies using drug delivery technologies to facilitate alternative routes of immunotherapy. The company's approach aims to improve efficacy, safety, and tolerability over traditional intravenous delivery methods. Foralumab's favorable safety profile and clinical response in patients have been demonstrated in studies to date.
The information in this article is based on a press release statement from Tiziana Life Sciences.
In other recent news, Tiziana Life Sciences Ltd has made significant developments in the biotech sector. The firm has been invited to apply for a grant from the ALS Association through the Hoffman ALS Clinical Trial Awards Program. This invitation comes in recognition of Tiziana's efforts in developing treatments for amyotrophic lateral sclerosis (ALS). The company's lead development candidate, foralumab, is being considered for a clinical trial, which could potentially benefit ALS patients.
In addition, Tiziana Life Sciences has sought FDA Orphan Drug Designation for foralumab, intended for non-active secondary progressive Multiple Sclerosis (na-SPMS). If granted, this could provide the company with up to seven years of marketing exclusivity. The FDA has also approved the expansion of its Expanded Access program for intranasal foralumab, now including 30 patients.
Furthermore, the company has reported significant findings from its research, indicating that intranasal foralumab therapy reduced brain inflammation in na-SPMS patients. Tiziana has also announced positive clinical results from its Expanded Access Program for na-SPMS patients, with 70% of the participants experiencing an improvement in fatigue. These recent developments underline Tiziana's commitment to advancing its research and providing potential new treatments for patients with limited options.
InvestingPro Insights
As Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) continues to innovate in the field of immunotherapy with its intranasal treatment foralumab, investors are closely watching the company's financial health and stock performance. With a market capitalization of $101.5 million, TLSA is a smaller biotech firm that is pushing the boundaries of treatment for multiple sclerosis. Despite the promising clinical outcomes, InvestingPro data highlights a challenging financial landscape for the company.
One of the critical InvestingPro Data metrics to consider is the company's Price / Book ratio, which stands at a high 18.34 as of the last twelve months ending Q4 2023. This suggests that the stock may be trading at a premium compared to its book value, which could be a point of caution for value-focused investors.
Moreover, TLSA's operating income shows a significant loss of $17.98 million during the same period, underscoring the financial risks inherent in biotech firms that are in the development phase without a profitable product on the market yet.
Investors should also note that TLSA is trading near its 52-week high, with a price that is 95.24% of this peak. This could indicate strong market confidence in the company's future prospects, especially considering the strong returns over the last three months, which have reached an impressive 100.38%.
Still, it is essential to balance this optimism with the InvestingPro Tips that caution about the company's weak gross profit margins and the expectation that net income may drop this year. Analysts are not anticipating profitability for TLSa within this fiscal year, which could impact long-term investment decisions.
For those interested in a deeper analysis, InvestingPro offers a range of additional tips to help investors make informed decisions. There are currently 11 more InvestingPro Tips available for TLSA, which can provide further insights into the company's financial health and stock performance. To access these valuable tips and more, consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Whether you're a seasoned investor or just starting, these insights can help you navigate the complex and often volatile biotech sector. With Tiziana Life Sciences' foralumab showing clinical promise, the financial metrics and expert analysis from InvestingPro are vital tools for anyone looking to invest in the future of healthcare.
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