Tiziana to launch clinical trial for MS therapy foralumab in late 2023

Tiziana Life Sciences plans to launch a Phase 2 clinical trial to investigate its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) in late 2023, the company announced.

The decision follows a Type C meeting with the U.S. Food and Drug Administration (FDA), wherein the agency provided feedback for the company’s Phase 2 program.

Tiziana intends to incorporate the recommendations in the trial’s protocol over the next few months and expects to launch the trial with an investigator’s meeting — where all involved meet in person to get familiar with the study — somewhere between June and October.

“I am grateful for the FDA’s thoughtful review of our Phase 2 plans for intranasal foralumab,” Matthew W. Davis, MD, chief medical officer at Tiziana, said in a company press release. “This upcoming quarter, we will update the Phase 2 protocol with the FDA’s suggestions and plan to start the Phase 2 clinical trial by holding our first investigator’s meeting in [the third quarter of] 2023.”

Foralumab is an antibody-based treatment being tested for multiple sclerosis (MS) and other diseases marked by inflammation in the brain and spinal cord.

It’s designed to block CD3, a protein on the surface of immune T-cells. By targeting this receptor, foralumab reduces the activity of certain T-cell subsets that contribute to the inflammatory attacks in MS, while boosting immunosuppressive T-cells that help keep the immune system in check.

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Antibody-based medicines often carry a higher risk of side effects than other therapies. Foralumab was designed to have minimal binding to unwanted targets, however, and is therefore expected to have fewer associated side effects. Administering it through the nose also is expected to cause fewer problems than other routes of administration would.

Foralumab is being investigated in six patients with nonactive SPMS — a form of MS marked by steady disability progression in the absence of relapses, for which only one treatment is approved.

Two patients are receiving the therapy under single-patient access programs and an expanded access program has enrolled four more. All are receiving a 50 microgram (mcg) dose into each nostril in three-week cycles — three doses a week for two weeks, followed by a week of rest.

Data from the single-access programs showed foralumab suppressed immune cell activation in the brain and resulted in improvements in cognition and walking function that’ve been sustained for at least six months.

One patient whose disability was worsening despite treatment with Ocrevus (ocrelizumab) saw improvements after starting on formalumab. The patient went from an Expanded Disability Status Scale (EDSS) score of 6 — meaning a cane was needed to walk 100 meters — to a 5 after 11 months, indicating the patient was able to walk 200 meters without a cane.

Additional data from all six patients are expected later this year.

“Tiziana has reached an important regulatory milestone as it proceeds with the first ever intranasal foralumab clinical trial,” said Gabriele Cerrone, executive chairman and interim CEO of Tiziana. “The FDA’s response to our proposed Phase 2 program allows Tiziana to advance foralumab through the regulatory process as we strive to bring this novel treatment to patients with nonactive SPMS.”