Phase 2 trial testing foralumab in nonactive SPMS adds 6 US sites
All study sites in Northeast, will allow PET scans to be done at 1 center
Tiziana Life Sciences is expanding its Phase 2 clinical trial testing foralumab nasal spray for the treatment of nonactive secondary progressive multiple sclerosis (SPMS), with six additional clinical sites across the northeastern region of the U.S.
The new sites, all at top U.S. institutions, bring together leaders in medical research and neurology with access to innovative facilities, Tiziana stated in a company press release. The new sites are Yale University in Connecticut, Johns Hopkins University in Maryland, Cornell University and the University at Buffalo, both in New York, University of Massachusetts, and Thomas Jefferson University in Pennsylvania.
“We are honored to collaborate with these prestigious institutions as we further expand our clinical trial,” said Ivor Elrifi, CEO of Tiziana.
According to Tiziana, the goal of adding only sites across the Northeast is for all patients to receive PET scans at a single Invicro imaging site, located in New Haven, Connecticut. This ensures that all patients will be examined with the same scan and using consistent imaging protocols, which minimizes variability in scan results.
“This milestone demonstrates our dedication to advancing innovative treatments for patients living with SPMS and underscores the potential of our platform to address complex neurodegenerative diseases,” Elrifi added.
Trial of foralumab nasal spray expanded, now with sites in 5 states
Nonactive SPMS is a progressive type of multiple sclerosis marked by a gradual worsening of symptoms without relapses, or sudden flare-ups, that follows an initial relapsing-remitting form of the disease. While more than 20 therapies are approved for the relapsing type of MS, one treatment, mitoxantrone, is available for treating patients who eventually transition to nonactive SPMS.
Tiziana’s foralumab is being developed to address this gap. The therapy targets a protein called CD3, found at the surface of immune T-cells, which simultaneously reduces the activity of inflammatory T-cells and boosts the activity of anti-inflammatory T-cells. This is expected to reduce the activation of other immune cells, such as microglia, and reduce inflammation to slow MS progression.
Foralumab is being tested in 10 people with nonactive SPMS in an expanded access program. Each of these patients has received treatment for more than six months. The therapy was given in three-week cycles, consisting of sprays into each nostril — at a 50 microgram dose — three times a week for two weeks, followed by one week of rest.
Data so far has shown that 80% of these patients had a reduction in the activity of microglia, which are brain-resident immune cells, in PET scans, and 70% also had less fatigue after six months. Importantly, all patients had either stable or improved disability levels after that period. Based on those findings, the U.S. Food and Drug Administration (FDA) allowed the company to enroll 20 more patients into the expanded access program.
Those data also supported the launch of the ongoing Phase 2 clinical trial (NCT06292923), launched at Brigham and Women’s Hospital of Harvard Medical School in Massachusetts. The trial dosed its first participant late last year.
The study is enrolling as many as 54 MS patients who experience continuous disease progression despite treatment with available therapies. Participants are receiving foralumab, at a dose of 50 mcg or 100 mcg, or a placebo, in three-week cycles.
Foralumab has been granted the FDA’s fast track designation for the treatment of nonactive SPMS. That status is designed to accelerate the development and review of medications that have the potential to fill unmet needs.
About the Author
