Expanded Access Program of Nasal Foralumab Enrolls 4 SPMS Patients

A group of four patients have entered a special program where they’ll gain access to foralumab nasal spray, an experimental therapy that’s being tested for non-active secondary progressive multiple sclerosis (SPMS).

This is the first group of four who entered Tiziana Life Sciences’ intermediate-size expanded access program. Recruitment started late last month and was completed in one week.

“We are very encouraged by the rapid enrollment of non-active secondary progressive multiple sclerosis in this study, which further validates the positive investigator feedback we have received about evaluating foralumab in this patient population,” Gabriele Cerrone, executive chairman and interim CEO of Tiziana, said in a company press release.

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4 SPMS patients will be treated at Brigham and Women’s Hospital in Boston

The four patients will be treated at Brigham and Women’s Hospital, in Boston, and receive foralumab at a dose of 50 micrograms (mcg). If needed, the program may enroll four more SPMS patients and treat them with a 100 mcg dose.

“This is the first time that non-active [SPMS] patients may receive a higher, 100 mcg dosing of intranasal foralumab versus the 50 mcg dosing previously studied,” Cerrone said.

People with SPMS experience a gradual worsening of symptoms caused by inflammation and damage to the nervous system. In patients with non-active disease, this worsening occurs over time without obvious attacks or relapses.

These data will be vital to confirming the durable clinical benefits of intranasal foralumab and will support our efforts to begin our Phase 2 study of foralumab in SPMS patients in mid-to-late 2023

Foralumab is an antibody treatment designed to reduce inflammation by binding to and blocking CD3. This is a protein found on the surface of T-cells, a type of immune cell involved in the immune attacks that drive MS.

The intermediate-size program of foralumab was based on data from two patients with non-active SPMS who have been receiving the therapy in single-patient expanded access programs.

The patients received 50 mcg of foralumab in three-week cycles — three doses each week for two weeks, followed by one week of rest — for six months.

While these patients were experiencing continuous disease progression before starting on foralumab, both saw improvements in cognition and walking function after three months that were sustained for at least six months.

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Alongside the clinical improvements, PET scans revealed that microglia in the brain were less active. Microglia are brain-resident immune cells whose activation is thought to contribute to inflammation in MS.

These two patients are set to undergo additional PET scans in the coming months to determine if the reduction in microglia activity is sustained over time. If positive, findings are expected to support a Phase 2 trial which Tiziana is planning to initiate in the second half of 2023.

“We are on track to conduct PET scans on our first two patients from our original study in the upcoming months,” Cerrone said in the press release announcing the start of the expanded access program.

“These data will be vital to confirming the durable clinical benefits of intranasal foralumab and will support our efforts to begin our Phase 2 study of foralumab in SPMS patients in mid-to-late 2023,” he added.