The first three participants have been dosed in a nasal spray antibody trial for early-stage ALS, testing whether it can calm nerve-damaging inflammation.
The BANYAN trial, part of the Healey ALS MyMatch programme, is evaluating whether the self-administered nasal spray can influence the immune system’s role in the progressive nerve condition, which currently has very limited treatment options.
Suma Babu, principal investigator of Healey ALS MyMatch and co-director of the Neurological Clinical Research Institute at Mass General Brigham, said the study marked “a significant step in advancing the development of foralumab for ALS”.
She said the trial was “designed to answer important questions about foralumab, specifically, whether it has a biological effect on Treg pathway in ALS, as measured by biomarkers”.
The study is recruiting 44 people who were diagnosed within the past two years, have a slow vital capacity of at least 65 per cent, and a neurofilament light chain level of at least 40 pg/mL, a blood marker linked to nerve cell damage.
Participants are randomised 3:1 to receive either the active drug or a placebo, over a 12-week controlled treatment period followed by a further 12 weeks in which all participants receive the active drug.
The main goal is to assess the safety and tolerability of the treatment in people with ALS, with secondary measures including changes in regulatory T cells, the immune cells thought to calm inflammation, and shifts in neurofilament light chain levels.
Researchers will also use brain scans to look for changes in microglial activation, a marker of inflammation in the brain and spinal cord.
ALS causes progressive loss of the nerve cells that control voluntary movement, and treatment options that slow its course remain scarce.
A nasal spray that patients could administer themselves, rather than an intravenous infusion, would mark a less invasive route to modulating the immune response implicated in the disease, though this early study is designed to establish safety and biological activity rather than clinical benefit.
The Healey ALS MyMatch programme uses an emerging genetic and plasma biomarker, pNfL, which was the basis of a recent accelerated approval for a genetic form of ALS, to match subgroups of people with ALS to experimental therapies based on their disease markers.
Ivor Elrifi, chief executive of Tiziana Life Sciences, the company developing foralumab, said dosing the first participants was a meaningful milestone, describing ALS as a disease with urgent unmet medical need and calling the nasal approach a way of trying to modulate neuroinflammation by inducing regulatory T cells that traffic to the central nervous system.
