4 new SPMS patients dosed with nasal foralumab outside of trials

10 patients now being followed in Tiziana's expanded access program

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Tiziana Life Sciences has dosed four new participants in an expanded access program investigating its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS), the company announced.

A total of 10 SPMS patients are now being followed outside of clinical trials in foralumab’s expanded access programs (EAPs), which are taking place at the Brigham and Women’s Hospital (BWH), in Boston.

Such programs allow individuals with serious or life-threatening conditions to have access to an experimental treatment outside of patient trials when there are no alternative therapies available. To date, two patients received foralumab as part of single-patient access programs, and the remaining eight are being treated in an intermediate-size EAP, according to a company press release.

Tiziana will use the data from the EAPs to obtain information on dosing and patient feedback, which will support the design of future studies. The company recently launched a Phase 2a clinical trial to investigate foralumab in people with nonactive SPMS. It’s expected to enroll the first participant before year’s end.

“Our dedication to advancing the field of multiple sclerosis research and providing patients with innovative treatment options is unwavering,” said Gabriele Cerrone, chairman, acting CEO, and founder of Tiziana Life Sciences.

“The anticipated enrollment of our first patient in the Phase 2a [nonactive]-SPMS trial this month brings us another step closer to fulfilling our mission of improving the quality of life for individuals living with [nonactive] SPMS, ” Cerrone added.

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2 patients to date have seen their symptoms ease after starting foralumab

Nonactive SPMS is a type of multiple sclerosis (MS) in which symptoms steadily worsen in the absence of relapses or new inflammatory lesions. The only treatment approved for this form of the disease is mitoxantrone, which is known to modulate the immune system and is used to slow disability progression in people with MS.

Foralumab is a human antibody-based therapy designed to reduce brain and spinal cord inflammation associated with MS and other neurodegenerative diseases. It works by blocking the CD3 receptor at the surface of immune T-cells, inhibiting these cells’ activity and reducing inflammation, while boosting the activity of regulatory T-cells that prevent excessive immune reactions.

According to the company, nasal delivery — using a spray — can potentially improve the treatment’s safety, tolerability, and efficacy compared with intravenous or into-the-vein infusions.

A Phase 1 clinical trial demonstrated that the therapy was safe and well tolerated in healthy volunteers. Moreover, it was able to modulate the immune system toward an anti-inflammatory response.

Participants in the ongoing EAPs all had experienced clinical disease progression despite treatment with available disease-modifying therapies. All now are receiving a 50 microgram (mcg) dose of foralumab sprayed into each nostril in cycles of three weeks. The dosage is three times weekly for two weeks, followed by a week of pause.

So far, the two patients in the single-patient access program have received the medication for more than one year, and the first four on the intermediate-size program have been dosed for at least six months. None has had serious side effects.

We are pleased to announce the commencement of dosing in the second intermediate-sized patient cohort for our [nonactive] SPMS Expanded Access Program.

Data from positron emission tomography (PET) imaging scans also demonstrated that five of these six patients had reductions in the activity of microglia — brain resident immune cells known to contribute to MS progression — at three and six months.

In addition, two patients experienced a reduction in disability, meaning that some of their symptoms eased after starting on the therapy. In the remaining four, disability scores remained stable over at least six months of treatment.

The final four patients enrolled in the intermediate-size program will now receive foralumab in a similar treatment regimen, but their dose may be higher than that previously tested.

“We are pleased to announce the commencement of dosing in the second intermediate-sized patient cohort for our [nonactive] SPMS Expanded Access Program,” Cerrone said.

The company said the data to date “are the first to combine imaging, immune-biomarkers, and clinical measures and safety data endpoints in patients receiving long-term” foralumab nasal spray.