Tiziana Life Sciences Ltd (NASDAQ:TLSA) said it has commenced site initiation for its lead intranasal foralumab program entering Phase 2a clinical testing in non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients.
Following an investigator’s meeting with principal investigators at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, the biotechnology company announced in a statement that six to 10 new clinical trial sites will be recruited, in total.
“As planned for this quarter, we are on track and have begun site initiation visits so patient enrollment begins in this critical clinical trial,” commented Dr Matthew Davis, Tiziana’s chief operating officer and chief medical officer.
“Advancing our lead anti-CD3 therapeutic, foralumab, in na-SPMS into Phase 2a will enable Tiziana to define novel endpoints, such as PET imaging, a similar target endpoint in our Expanded Access program (EAP). We are encouraged as five out of six patients in our open-label EAP have improved by qualitative analysis in their PET scans (3 months of treatment) compared to baseline.
“Phase 2a na-SPMS study assesses the same outcome measure, but now, and for the first time for this novel therapeutic, in a double-blind, randomized placebo control, a multi-center trial is now underway,” Davis added.
The company noted that foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, suppressing effector features in multiple immune cell subsets.
This effect has been demonstrated in patients with COVID-19, multiple sclerosis, and healthy, normal subjects.
Intranasal foralumab Phase 2 trials have begun in patients with non-active SPMS. Nasal anti-CD3 mAb represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.
Tiziana is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy.
Its shares were 3.5% higher at $0.68 by noon in New York.
~Updated with share price movement~
Contact the author at stephen.gunnion@proactiveinvestors.com