Tiziana Life Sciences has announced that a Phase 1 clinical trial of its intranasal Foralumab human anti-CD3 monoclonal antibody was well tolerated at doses of 10, 50 and 250 µg per day and demonstrated “significant positive immune effects.” The company is developing intranasal Foralumab, which it licensed from Novimmune in 2014, for the treatment of neurodegenerative diseases such as multiple sclerosis.
The study compared nasal Foralumab to placebo in healthy volunteers over 5 days. According to the company, the 50 μg dose elicited the greatest immune effect, suppressing CD8+ and cytokine IFN-γ, and stimulating production of cytokine IL-10. Tiziana had announced the initiation of the study in November 2018.
Harvard Medical School Professor Howard L. Weiner, a member of Tiziana’s Scientific Advisory Board, said “Nasal administration of Foralumab is a revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) and amyotrophic lateral sclerosis (ALS). Extensive data from animal studies with intranasal delivery of anti-CD3 demonstrate that this route of administration induces anti-inflammatory and immunomodulatory effects. This study demonstrates for the first time that nasally administered Foralumab, at the identified optimal dose of 50 μg, induces immunomodulatory effects capable of providing clinical benefit to treated subjects. This is a major accomplishment providing the scientific rationale to move forward with further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases. . . . Our immediate focus is on developing Foralumab for treatment of pro-MS.”
Tiziana CEO and CSO Kunwar Shailubhai added, “We are very pleased with what we believe is the first-ever demonstration that nasally administered Foralumab is not only well-tolerated, but it also exhibited significantly positive immunomodulatory effects that are indicative of stimulation of Tregs. We are excited as these results provide the scientific rationale for the nasal and oral treatment with Foralumab, our core proprietary platform technologies which could potentially revolutionize treatment with antibodies.”
Read the Tiziana Life Sciences press release.
