Tiziana Life Sciences PLC (LON:TILS, NASDAQ:TLSA) said its breakthrough fully-human monoclonal antibody “induces immunomodulatory effects capable of providing clinical benefit” when administered nasally.
The latest data come from a phase I assessment of Foralumab, which is being developed for a range of neurodegenerative diseases such as multiple sclerosis, amyotrophic lateral sclerosis and Alzheimer's disease.
Its delivery via the nose rather than orally or by injection is being pioneered by Tiziana and Dr Howard Weiner, chair of the company’s scientific board and a Harvard professor.
The study revealed the treatment was well-tolerated at all doses and there were no apparent symptoms of severe toxicity.
Importantly, the drug showed “significant positive effects” at a 50 micrograms per day dose on T-cell subsets and inflammatory biomarkers.
Tiziana said the latest data supported clinical and pre-clinical studies showing that this route of administration (where the medication is inhaled via the nose) is capable of inducing “site-targeted immunomodulation and anti-inflammatory effects”.
Specifically, it chimed with the feedback received from a recent evaluation of Foralumab in COVID sufferers across a range of doses
The company said the biochemical and physiological (pharmacodynamic) results “point to a clinical dose range that Tiziana intends to test in further clinical development among MS patients”.
“This study demonstrates for the first time that nasally administered Foralumab, at the identified optimal dose of 50 mcg/day, induces immunomodulatory effects capable of providing clinical benefit to treated subjects,” said Weiner.
He described the results of the phase I trial as a “major accomplishment” that provided the scientific rationale to move forward with the further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases.