Tiziana Life Sciences has announced that the Phase 2a INFORM-MS study of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis met both of its primary endpoints, demonstrating significant reduction in microglial activation at Week 12 for the lower of two doses tested as well as safety and tolerability for both doses. The INFORM-MS study was initiated at the end of 2023 and expanded a year later.
In addition to meeting the primary endpoints, the trial demonstrated significant improvement in fatigue for both doses, with a greater than 4 point increase in average fatigue scores at Week 12. According to Tiziana, the study enrolled 48 patients, with 19 receiving a 50 mcg dose of foralumab, 11 receiving a 100 mcg dose, and 18 receiving a placebo. Dosing was up to 3 days a week for 2 weeks followed by a week of rest, with the cycle repeated 4 times over 12 weeks.
Tiziana CEO Ivor Elrifi commented, “We are extremely pleased that INFORM-MS successfully met its primary endpoints for both safety and reduction in neuroinflammation measured by PET imaging of microglial activation. The statistically significant, and clinically significant improvements from baseline in MFIS at both 50 μg and 100 μg doses further strengthens our conviction in the potential of intranasal foralumab. These data, together with the accumulating real-world evidence from our expanded access program in na-SPMS patients, as well as emerging data from our current trials in AD, ALS, and MSA, positions us well as we advance foralumab to the next stage of development.”
Read the Tiziana Life Sciences press release
