Tiziana Life Sciences Ltd (NASDAQ:TLSA) said its near-term focus is on developing intranasal foralumab for inflammatory diseases of the central nervous system (CNS), including non-active secondary-progressive Multiple Sclerosis (SPMS), Alzheimer’s disease and amyotrophic lateral sclerosis.
Tiziana interim CEO Gabriele Cerrone said the biotechnology company is looking forward to leveraging the clinical and pre-clinical results from the promising formulation of intranasal foralumab generated so far in CNS-based autoimmune diseases to guide its pipeline investment.
“Our near-term strategic focus to prioritize resources for the clinical development of this unique therapeutic candidate will allow Tiziana to focus on areas of greatest potential success, be highly efficient in our development timelines and maximize shareholder value while still maintaining optionality for our other research programs, including milciclib in oncology,” Cerrone said in a statement.
READ: Tiziana finishes enrolling first patient cohort for expanded access program evaluating Foralumab in advanced stage multiple sclerosis
“We aim to become a leading company pioneering intranasal therapies for CNS-based diseases and have sufficient capital to fund our programs until the first quarter of 2024.”
New York-based Tiziana said its fully human anti-CD3 monoclonal antibody – foralumab – administered intranasally through its proprietary drug delivery technology, has shown benefit in several different pre-clinical models of CNS-based inflammatory disease.
These studies confirmed the uptake of the drug in the cervical lymph nodes of animal models – an area rich in lymphocytes that is a key site of action to target – as it then spurs the production of T-cells and reduces inflammation, according to Tiziana.
Tiziana chief medical officer Dr Matthew W Davis said that, along with the company’s academic partners, the company believes that many inflammatory CNS disease pathologies could benefit from intranasally administered foralumab.
“As such, we are focusing our efforts in this area due to the positive clinical and pre-clinical findings we’ve seen to date across several CNS inflammatory diseases. We embark on this journey with our partners at Brigham and Women’s Hospital and look forward to studying intranasal foralumab to address a range of underserved inflammatory CNS conditions,” Davis added in a statement.
MS program update
Tiziana said it expects to announce the results of the six-month PET scan on patient EA2 and the nine-month PET scan on patient EA1 in the first quarter of 2023.
Additionally, Tiziana said it recently announced the completion of enrollment for the first cohort of its intermediate-size patient population (four patients) to continue to evaluate the safety and activity of intranasal foralumab in non-active SPMS patients, as part of its expanded access program. During the first quarter of 2023, the company said it plans to perform three-month PET scans on patients EA3 through EA6, anticipating the results to be available in 2Q 2023.
Separately, in the fourth quarter of 2022, Tiziana said it expects to request a Type C meeting with the FDA to discuss its Phase 2 program for evaluating foralumab in non-active SPMS patients and to receive feedback from the FDA by the end of the first quarter of 2023.
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