Tiziana seeks sites to conduct Phase 2a trial of nasal foralumab

Tiziana Life Sciences has started to recruit clinical sites for a Phase 2a clinical trial that will investigate its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS).

The announcement follows a meeting with the principal investigators of the trial at Brigham and Women’s Hospital (BWH), in Boston, Massachusetts. In total, six to 10 clinical trial sites are expected to participate.

“As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial,” Matthew Davis, MD, Tiziana’s chief operating officer and chief medical officer, said in a press release.

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Foralumab is an antibody-based treatment designed to reduce the inflammation in the brain and spinal cord that drives multiple sclerosis (MS) and other neurodegenerative diseases.

The therapy works by blocking the CD3 receptor at the surface of immune T-cells, which suppresses the activity of cells that contribute to inflammation in these conditions, while boosting the activity of regulatory T-cells that work to prevent excess immune reactions.

A Phase 1 clinical trial tested foralumab in healthy individuals and demonstrated the nasal spray was safe and well tolerated. The therapy also worked as expected, modulating the immune system toward a more anti-inflammatory response.

Patients enrolled in expanded access programs

Foralumab is currently being investigated in six people with nonactive SPMS, who are receiving the therapy at BWH as part of expanded access programs. Nonactive SPMS is a type of MS in which symptoms steadily worsen in the absence of relapses or new inflammatory lesions. So far, only mitoxantrone is approved for this form of the disease.

Among the six patients, two are receiving the treatment under single-patient access programs, and four are enrolled in an intermediate-size program. All are receiving a 50 microgram (mcg) dose of foralumab sprayed into each nostril in three-week cycles — three times a week for two weeks, followed by a week of pause.

Results from the first two patients, who were experiencing progressively worsening disability despite treatment with approved MS medications, demonstrated the therapy led to disability improvements (an easing in disability), which were sustained for at least six months. One patient also had improvements in walking ability, cognition, and dexterity after six months.

Importantly, PET scans showed that microglia — the resident immune cells in the brain, whose activation is thought to contribute to inflammation in MS — were less active at three and six months after treatment initiation.

More recent data from the latest four patients have come to confirm this result, with three of them also showing reductions in microglial activation after three months.

“We are encouraged as five out of six patients in our open-label [expanded access programs] have improved by qualitative analysis in their PET scans (3 months of treatment) compared to baseline,” Davis said.

Randomized and double-blind Phase 2 trial

The Phase 2 trial will be a multicenter trial in which patients will be assigned randomly to receive either the treatment or a placebo, and both investigators and patients do not know which one they are receiving.

One of its outcome measures will be the reduction in microglial activity in PET scans, “a similar target endpoint in our Expanded Access program,” Davis added.