First SPMS Patient Dosed With Foralumab Nasal Spray

Foralumab, an investigational anti-CD3 antibody that is administered via a nasal spray, has been given for the first time to a person with secondary progressive multiple sclerosis (SPMS).

It was administered under an Individual Patient Expanded Access Program, which earned approval from the U.S. Food and Drug Administration in April. It seeks to investigate the safety, tolerability, and changes in neurological behaviors after six months of foralumab use.

The first patient was dosed at the Brigham and Women’s Hospital, Harvard Medical School, in Boston, Massachusetts, and will receive 50 micrograms of foralumab into the nose in three-week cycles. Each cycle consists of three doses per week for two weeks, followed by a one-week rest period.

The study also will examine the activation of microglia (cells involved in the brain’s immune system), as well as immunological and neurodegenerative markers, to understand clinical responses associated with the treatment.

“Nasally administered anti-CD3 is an exciting, novel approach that has the ability to provide safe treatment for a form of MS that currently has no effective treatment,” Howard Weiner, MD, the Harvard neurology professor who reformulated foralumab for nasal delivery, said in a press release.

“We are excited to examine this first-in-class approach to treat patients with SPMS for whom no effective treatment option is currently available,” he added.

Foralumab is an experimental antibody that targets the CD3 receptor on immune T-cells. This dampens the potential damaging immune responses of T-cells and increases the activity of regulatory T-cells (negative regulators of the immune system), which is expected to benefit people with autoimmune conditions like MS.

Tiziana Life Sciences, the therapy’s developer, recently completed a Phase 1 clinical trial of foralumab in healthy individuals. Participants in this trial received ascending doses of 10, 50, and 250 micrograms once daily for five consecutive days. Tiziana reported the treatment was well-tolerated, with no treatment-related safety issues at any of the doses tested.

The company later reported positive data from an exploratory clinical study of nasal foralumab in COVID-19 patients in Brazil.

In that study, 40 patients were assigned randomly to receive either 100 micrograms of nasal foralumab plus three days of priming with 6 mg oral dexamethasone (12 participants), nasal foralumab alone (12 patients), or no treatment (16 patients) for 10 days. Similar to the other Phase 1 trial, results indicated that foralumab was well-tolerated with no apparent severe adverse side effects.

This trial also indicated that foralumab significantly reduced lung inflammation, as well as the levels of two inflammation biomarkers: interleukin-6 and C-reactive protein.

“Effective and targeted treatments for progressive MS are urgently needed,” said Tanuja Chitnis, a senior neurologist at Brigham and Women’s Hospital, where the current study takes place. “Nasal foralumab could revolutionize treatment for this disabling form of disease.”