Tiziana inks deal for clinical trial testing its experimental treatment in RRMS
Nasal therapy foralumab will be tested in combination with anti-CD20 therapy
Written by |
Tiziana Life Sciences has signed a deal with strategic partners to support a clinical trial testing its experimental nasal therapy foralumab in people with hard-to-treat RRMS. (Photo by iStock)
- Tiziana Life Sciences is partnering to test foralumab in patients with RRMS.
- The trial will test foralumab plus anti-CD20 therapy.
- Foralumab will be evaluated as an add-on treatment.
Tiziana Life Sciences has signed a deal with strategic partners to support a clinical trial designed to test its experimental nasal therapy foralumab in people with hard-to-treat relapsing-remitting multiple sclerosis (RRMS).
Under the signed Memorandum of Understanding (MOU), the collaboration involves Tiziana, The King Abdullah International Medical Research Center in Saudi Arabia, and the U.S.-based Foundation for Neurologic Diseases, a research organization that focuses on neurological conditions like MS.
The trial will test foralumab plus anti-CD20 therapy — a treatment class that includes the approved RRMS therapies Briumvi (ublituximab-xiiy), Kesimpta (ofatumumab), and Ocrevus (ocrelizumab) — in RRMS patients showing inadequate responses to anti-CD20 therapy alone.
“This MOU marks an important step in fostering international scientific collaboration in neuroimmunology and immunomodulation research,” Ivor Elrifi, CEO of Tiziana, said in a company press release. “We are pleased to partner with KAIMRC along with the Foundation for Neurologic Diseases to explore opportunities that align with our mission of advancing innovative therapies for neurodegenerative and neuroinflammatory diseases, including a clinical trial of foralumab in combination with anti-CD20 therapy for RRMS patients having suboptimal responses to anti-CD20 treatment alone.”
Some RRMS patients have disease activity despite anti-CD20 treatment
Multiple sclerosis is an autoimmune disease marked by inflammation in the brain and spinal cord. At disease onset, the most common form is RRMS, which is marked by relapses where symptoms suddenly worsen, followed by periods of remission where symptoms are stable.
A range of treatments are widely available for RRMS. Anti-CD20 therapies work by killing B-cells, a type of immune cell with a key role in driving MS.
This type of treatment have been proven to reduce the risk of flares in RRMS, but as with any medication, not everyone responds in the same way. Some people with RRMS continue to have notable disease activity despite anti-CD20 treatment.
According to Tiziana, these patients likely are experiencing inflammation that isn’t fully controlled by anti-CD20 treatment, lending a biological rationale for add-on therapy to target other drivers of inflammation.
Foralumab could also be a potential treatment for na-SPMS
Foralumab is an antibody-based therapy designed to reduce the inflammatory activity of T-cells and microglia, which are other types of immune cells that contribute to inflammation in MS. The upcoming clinical trial will test foralumab as an add-on treatment for people with RRMS whose disease is not adequately controlled by anti-CD20 treatment alone.
Over time, RRMS may develop into secondary progressive MS (SPMS), which is characterized by symptoms that get gradually worse over time irrespective of relapse activity. Some people with SPMS still experience disease flares, known as active SPMS. Treatments for RRMS are also often used to manage active SPMS.
But for people with SPMS who do not experience flares — known as non-active SPMS or na-SPMS — options are much more limited. Tiziana is also developing foralumab as a potential treatment for na-SPMS.
A U.S.-based Phase 2a study called INFORM-MS (NCT06292923) is currently testing foralumab in adults with na-SPMS. Dosing of the last patient was initiated in June.
Foralumab’s new program in RRMS “represents an additional Multiple Sclerosis type beyond our ongoing non-active Secondary Progressive MS (na-SPMS) program, and does not change our efforts toward na-SPMS, where the Phase 2 trial remains blinded with results expected in October this year,” Elrifi said.
Leave a comment
Fill in the required fields to post. Your email address will not be published.