2nd Patient to Get Foralumab Nasal Spray After Promising First Data

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by Lindsey Shapiro, PhD |

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Following promising data from the first participant in a special access program that’s testing foralumab nasal spray for secondary progressive multiple sclerosis (SPMS), a second patient has been enrolled in the ongoing evaluation.

The first patient in the study, by Tiziana Life Sciences, the nasal spray’s developer, was halfway through the course of treatment, and early data indicated that foralumab was well-tolerated and effective, the company said.

The new enrollment was authorized by the U.S. Food and Drug Administration (FDA).

“New treatments for progressive [multiple sclerosis] are urgently needed. Intranasal foralumab could revolutionize treatment for this disabling form of disease,” Tanuja Chitnis, MD, professor of neurology at Harvard Medical School and senior neurologist at Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital, said in a press release. Chitnis is the principal investigator.

Foralumab is an experimental antibody treatment that binds to the CD3 receptor on immune T-cells to suppress immune responses, which could benefit patients with autoimmune disorders like multiple sclerosis (MS).

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First developed as an oral therapy, foralumab has been reformulated for nasal delivery. Tiziana is now evaluating this intranasal formulation — a nasal spray — in patients with SPMS, a progressive form of MS.

The first patient enrolled in the study is halfway (three out of six months) through the treatment, which is being administered at BWH. No signs of toxicity have been observed, and positron emission tomography (PET) — an imaging technique — showed a reduction in the activation of microglia, cells involved in the brain’s immune response that can be overactive in SPMS.

“We are extremely pleased with the tolerability of the treatment seen to date as well as with the positive clinical responses observed after completion of three months of dosing in the first patient,” said Howard Weiner, MD, director of the multiple sclerosis program at BWH and chairman of Tiziana’s Scientific Advisory Board.

“We look forward to clinical data after completion of six months of treatment,” Weiner said.

Tiziana submitted the three-month safety data to the FDA to support its request for the enrollment of the additional patient. That request was approved under the FDA’s Individual Patient Expanded Access Program.

This second patient will be given 50 micrograms of foralumab in three-week cycles — three doses per week for two weeks then a one-week rest period — following the same dosing schedule used for the first participant.

The six-month course of treatment is expected to begin this month, with interim data, including safety, neurological changes, and PET imaging, available in April of this year.

Meanwhile, the first patient will continue the dosing regimen, which is expected to conclude in March.

A now completed Phase 1 clinical trial of nasal foralumab in healthy volunteers found it to be safe and tolerable, with promising immunomodulatory effects. Such effects included reduced T-cell subsets, suppressed production of inflammatory molecules, and enhanced production of anti-inflammatory molecules.

Tiziana anticipates that a Phase 2 trial for nasal foralumab in patients with progressive forms of MS will be initiated soon.

Foralumab also is being tested for other disorders.

“We have been systematically building a database of evidence to support both the safety and clinical potential of intranasal and oral forms of foralumab in close collaboration with the FDA, and during 2022 plan to initiate several new trials across areas of large unmet need, including MS, Crohn’s disease, and type 1 diabetes,” said Kunwar Shailubhai, PhD, CEO of Tiziana.

“Today’s update marks important progress in the advancement of our MS program, and supports our novel approach to provide local, rather than systemic delivery of antibodies,” Shailubhai added.