Tiziana, Renaissance partner to accelerate intranasal foralumab
Treatment being tested for nonactive SPMS in expanded access program
Tiziana Life Sciences is partnering with a contract development and manufacturing organization with expertise in intranasal drugs to accelerate the development and commercial launch of foralumab, a treatment designed to be sprayed into the nose.
Tiziana’s medication is being investigated in an expanded access program (EAP) and a Phase 2a clinical trial (NCT06292923) in people with nonactive secondary progressive multiple sclerosis (SPMS).
Developer and manufacturer Renaissance Lakewood will use its expertise in nasal products to optimize the current formulation and establish a plan to scale up foralumab manufacturing, Tiziana said.
Foralumab is an antibody-based therapy being developed for nonactive SPMS, a form of multiple sclerosis (MS) with limited treatment options. While more than 20 therapies are approved for relapsing types of MS, only one treatment, mitoxantrone, is available for people with nonactive SPMS.
“Partnering with Renaissance is a significant milestone in our mission to bring intranasal foralumab to patients in need,” Ivor Elrifi, PhD, Tiziana’s CEO, said in a company press release. ”Their proven track record in pharmaceutical manufacturing will be invaluable as we advance our clinical programs and prepare for potential market entry.”
Foralumab may slow disease progression
Foralumab works by targeting and blocking the CD3 receptor protein found at the surface of T-cells, immune cells involved in the inflammatory attacks that cause MS. This is expected to simultaneously reduce the activity of the inflammatory T-cells that cause MS damage and increase the activity of regulatory T-cells that prevent excessive inflammation.
By easing inflammation, foralumab may slow disease progression in people with nonactive SPMS.
Nonactive SPMS patients in the EAP are receiving 50 mcg of foralumab in three-week cycles — one spray in each nostril three times a week for two weeks, followed by one week of rest.
Data from the first 10 participants showed that most (80%) experienced a reduction in microglial activity shown on PET scans — an indication that brain inflammation was reduced — and 70% also had reductions in fatigue after six months. Over that period, patients either had stable disability levels or improvements; none had worsening disability.
Based on the findings, the U.S. Food and Drug Administration (FDA) cleared Tiziana to enroll 20 more patients into the EAP, four of whom were dosed earlier this month.
The company is also running a Phase 2a trial seeking to enroll about 54 participants with nonactive SPMS. Participants are receiving foralumab, at a dose of 50 mcg or 100 mcg, or a placebo, for three months in a schedule similar to that used in the EAP. Dosing started late last year, and the trial is expected to conclude this year.
The main goals are to assess the treatment’s safety and confirm its ability to reduce microglial activity in PET scans over three months. Disability progression, as well as changes in fatigue, lesions, and in a composite measure of walking ability, dexterity, cognition, and vision will also be assessed.
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