Foralumab nasal spray shown to ease fatigue in nonactive SPMS

Six of eight patients with nonactive secondary progressive multiple sclerosis (SPMS) being treated with foralumab nasal spray — all part of an intermediate-size expanded access program (EAP) allowing the therapy’s use — have experienced reductions in their fatigue levels.

That’s according to treatment developer Tiziana Life Sciences, which is reporting data from positron emission tomography (PET) scans obtained at three months of treatment.

Those scans also revealed that the same six patients had a reduction in the activity of microglia, the brain’s resident immune cells, which are known to contribute to disease progression in multiple sclerosis.

A total of 10 patients are now being followed as part of foralumab’s expanded access programs, which are taking place at Brigham and Women’s Hospital, in Boston. PET scans for the two additional patients should be available later this month, the company said.

“These findings are promising from an imaging standpoint and further studies are needed to confirm them using additional quantitative approaches,” Tarun Singhal, MD, who directs the PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, said in a Tiziana press release.

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Phase 2 clinical trial now testing foralumab nasal spray in nonactive SPMS

While more data from these patients are awaited, the company is running a Phase 2 clinical trial testing its foralumab nasal spray versus a placebo in up to 54 people with nonactive SPMS. The first patient has been dosed, and early data are expected by the end of 2024.

“We’ve seen continued clinical and qualitative PET scan improvement over time,” said Gabriele Cerrone, Tiziana’s chairman, acting CEO, and founder, noting that the experimental therapy targets inflammation in the brain.

“It is my expectation that we will rapidly progress our ongoing Phase 2 trial of intranasal foralumab, given the encouraging results seen so far,” Cerrone said.

Nonactive SPMS is a type of multiple sclerosis (MS) in which symptoms worsen gradually in the absence of obvious relapses or new inflammatory lesions in the brain or spinal cord. Mitoxantrone, an infusion medication, is the only treatment approved to date for nonactive SPMS patients in the U.S.

An antibody, foralumab is designed to reduce inflammation in the brain and spinal by blocking CD3, a protein found on the surface of T-cells. This type of immune cells is involved in MS progression. Treatment is expected to block the activity of T-cells, while boosting the activity of regulatory T-cells that help keep the immune system in check.

So far, two patients have received foralumab under single-patient expanded access programs, while another eight are being treated in an intermediate-size program. Such programs allow patients to gain access to an experimental treatment outside of clinical trials when no other option is available.

Both the programs and the clinical trial are testing foralumab nasal spray at a 50 microgram (mcg) dose. The treatment is given in three-week cycles, consisting of sprays into each nostril three times a weeks for two weeks, followed by a week of pause.

It is my expectation that we will rapidly progress our ongoing Phase 2 trial of intranasal foralumab, given the encouraging results seen so far.

The new data showed an easing of fatigue for the six patients who also had reduced microglial activity, with “a qualitative improvement” in scores on the Modified Fatigue Impact Scale (MFIS), according to Tanuja Chitnis, MD, a professor of neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital.

“Six out of the eight … patients studied so far have seen measurable clinical improvement in their fatigue,” Chitnis said.

Earlier data from the first six patients who received foralumab in the expanded access programs showed reductions in microglial activity in five patients at three and six months. Also, none of the patients experienced disability progression — two improved and four remained stable.

Data from two additional patients now showed that one also experienced a reduction in microglia activity at three months. That means that six of eight patients so far have experienced such improvements after three months.

Researchers hoped the clinical trial will produce similar results to those seen in the EAP programs.

“I am excited to lead the effort to replicate these findings in the ongoing Phase 2 dose-ranging, randomized, placebo-controlled clinical trial,” Chitnis said.