October 20, 2023
The FDA’s decision to allow at-home dosing of intransal foralumab for patients with multiple sclerosis is likely to improve patient compliance to treatment and health outcomes, according to a recent release statement.
This was originally published in NeurologyLive.
Foralumab is designed to bind to T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. The agent is administered intranasally, providing a novel avenue for the treatment of inflammatory human diseases. Tiziana also noted they developed delivery device training materials and refined them in collaboration with the agency. Therefore, patients with MS will be trained in the use of the nasal device in accordance with the instructed materials.
“Traditionally, patients with MS had to visit healthcare facilities for treatment, which could be inconvenient and burdensome. The FDA’s approval for home dosing of foralumab will transform the way patients manage their condition, offering them greater control over their treatment schedules and the convenience of receiving care in their familiar environment,” Gabriele Cerrone, executive chairman and interim chief executive officer at Tiziana Life Sciences, said in a statement.1 “We are elated with the FDA’s allowance for home dosing of intranasal foralumab. This step significantly aligns with our mission to make innovative therapies more accessible to patients and ultimately improve their quality of life. We believe that this treatment approach will revolutionize the way patients with MS manage their condition.”
At MSMilan 2023, the joint ECTRIMS-ACTRIMS meeting, held October 11-13, in Milan, Italy, a small-scale study of patients with non-active secondary progressive multiple sclerosis (SPMS) treated with foralumab showed improvements in clinical measures of fatigue and physical function. All patients with SPMS in the study (n = 6) experienced improvement in at least 1 clinical measure of Expanded Disability Status Scale (EDSS), pyramidal score, or Modified Fatigue Impact Score (MFIS), and all but 1 (5 of 6) showed improvement on microglial PET imaging at 6 months.
Using 18F-PBR06-microglial PET imaging, results showed that 5 of the 6 participants had reductions in PET signal at 3- and 6-months after initiating treatment. Notably, no new T2 or gadolinium-enhancing lesions were noted on post-treatment 3T MRIs. The therapy was shown to be safe and well tolerated with runny nose and nasal congestion, both self-limited, as the only treatment-related adverse events (AEs). Two patients had serious AEs deemed unrelated to the study drug (Patient EA1 and EA2 – COVID diagnosis; EA1 – 2 episodes UTI/cystitis associated with benign prostatic hyperplasia).