Proactive - Interviews for investors

Tiziana Life Sciences reports positive phase 2a results for Intranasal Foralumab in MS

Episode Summary

Tiziana Life Sciences CEO Ivor Elrifi joined Steve Darling from Proactive to discuss positive topline results from the company's Phase 2a INFORM-MS clinical trial evaluating intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (na-SPMS). Non-active secondary progressive MS is a form of the disease in which patients experience a gradual accumulation of disability independent of relapses. The company noted that there are currently no FDA-approved therapies specifically indicated for na-SPMS, leaving a significant unmet medical need, particularly around progressive disability and fatigue. Elrifi told Proactive that the randomized, double-blind, placebo-controlled study met both of its primary endpoints. The first endpoint demonstrated a statistically significant reduction in neuroinflammation after 12 weeks of treatment in patients receiving the 50-microgram intranasal foralumab dose compared with placebo. The second endpoint showed that both the 50-microgram and 100-microgram doses were safe and well-tolerated. The company said the primary imaging endpoint, measured using TSPO PET scans, showed reduced neuroinflammation in the 50-microgram treatment group. The findings point to a reduction in microglial activation, an important biological process associated with inflammation in the central nervous system. Tiziana also highlighted improvements in fatigue measured using the Modified Fatigue Impact Scale (MFIS). The company described the clinical improvement as notable given the relatively short 12-week treatment period. According to Elrifi, the results provide encouraging evidence of intranasal foralumab's biological activity in a patient population with limited treatment options. The company said the favourable safety and tolerability findings across both dose groups further support continued investigation of the therapy. Looking ahead, Tiziana plans to complete a comprehensive analysis of the INFORM-MS data and present the detailed findings at an upcoming scientific congress. The company also intends to engage with the U.S. Food and Drug Administration to discuss the trial results and potential next steps for the clinical development of intranasal foralumab in non-active secondary progressive MS. #proactiveinvestors #tizianalifescienceslts #nasdaq #tlsa #newceo #ivorelrifi #Foralumab #MultipleSclerosis #MSResearch #SecondaryProgressiveMS #Neuroinflammation #Immunotherapy #Biotechnology #ClinicalTrials #Phase2a #HealthcareInnovation #DrugDevelopment