Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced that Johns Hopkins University has begun dosing patients in its Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
This marks the third clinical site for the trial, alongside Brigham and Women’s Hospital and Yale Medical Center.
The trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of intranasal foralumab, a fully human, anti-CD3 monoclonal antibody designed to modulate the immune system and address neuroinflammation.
The blinded portion of the trial is expected to conclude by the end of 2025, after which all participants, including those initially receiving a placebo, will have the option to enter a six-month open-label extension period for further evaluation.
Shares of Tiziana moved 1.9% higher on Wednesday morning.
'Significant milestone'
“The addition of Johns Hopkins University to our Phase 2 trial to is a significant milestone in our mission to develop a novel approaches and treatment for na-SPMS,” Tiziana’s chief development officer William Clementi said in a statement.
“Intranasal foralumab has demonstrated promising potential in modulating the immune system to reduce neuroinflammation, and we are eager to continue advancing this study to provide new hope for patients facing this disabling condition.”
Tiziana CEO Ivor Elrifi added: “We believe intranasal foralumab represents a paradigm shift in addressing non-active Secondary Progressive MS, and we remain dedicated to advancing its development to benefit patients in need.”
Dr Pavan Bhargava, Professor of Neurology and principal investigator at JHU, highlighted the importance of advancing novel treatments for na-SPMS.
“Patients with non-active SPMS currently have limited treatment options, and there is an urgent need for therapies that can modulate compartmentalized neuroinflammation and potentially slow disease progression,” Dr Bhargava said.
“We are excited to participate in this clinical trial and explore the potential benefits of foralumab in this underserved population.”