Tiziana seeks ALS Association grant to test foralumab for ALS

Early-stage clinical trial would enroll 20 patients

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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Tiziana Life Sciences has applied for a grant from the ALS Association to fund an early-stage clinical trial testing intranasal foralumab as a potential therapy for amyotrophic lateral sclerosis (ALS).

The association invited the company to apply for the grant, which is offered under the Hoffman ALS Clinical Trial Awards Program. The program is designed to support early clinical trials, usually meant to produce safety, dosing, and biomarker data to advance the development of investigational therapies.

“We are deeply honored to be invited by the ALS Association to apply for this grant, which represents a significant milestone in our ongoing efforts to develop an effective treatment for ALS,” Gabriele Cerrone, Tiziana’s chairman, acting CEO, and founder, said in a company press release. “This funding would allow us to advance our clinical program and accelerate the development of our potential therapy that could make a meaningful difference in the lives of ALS patients.”

The company said it would use the funds to launch a clinical trial involving 20 ALS patients, who would receive ascending doses of intranasal foralumab for six months.

“Tiziana’s study goal is to give people living with amyotrophic lateral sclerosis (ALS) the opportunity to participate in a 6-month, dose-titration trial of intranasal foralumab,” said James Berry, MD, director of the Neurological Clinical Research Institute at Massachusetts General Hospital. Berry will co-lead the trial along with Suma Babu, the institute’s co-director.

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While the mechanisms behind ALS aren’t completely understood, inflammation is believed to be a key process contributing to disease onset and progression. This is caused by an excess activation of several immune cell types, including T-cells and microglia, the brain’s resident immune cells.

Foralumab is an antibody-based therapy designed to reduce inflammation by targeting the CD3 protein on the surface of immune T-cells.

In animal models, the medication was found to reduce the activity of inflammatory T-cells while increasing the function of regulatory T-cells, which regulate the inflammatory activity of other immune cells. This shift in T-cell subtypes is expected to further dampen the activity of other immune cell types.

Foralumab is being tested as a nasal spray formulation in a Phase 2a trial (NCT06292923) enrolling about 54 adults with nonactive secondary progressive multiple sclerosis (MS), another neurodegenerative disease.

The medication has been tested in MS patients as part of an expanded access program and either stabilized or reversed disability levels in all patients after six months, while reducing the activity of microglia visible on PET scans.

Tiziana previously received a grant from the ALS Association supporting preclinical studies to determine whether foralumab could also reduce the activation of microglia in an animal model of ALS.

The potential ALS clinical trial “is aimed at advancing novel treatment approaches for ALS by evaluating its effect using cutting-edge image biomarkers like positron emission tomography (PET) and key clinical outcome assessments,” said Babu.