Tiziana Life Sciences reports positive Phase 2a results for intranasal foralumab in non‑active secondary progressive MS
+1 new source since this summary was written
Tiziana Life Sciences announced that its Phase 2a INFORM‑MS trial met both primary endpoints, showing a statistically significant reduction in brain inflammation and improvements in fatigue for the 50 µg intranasal foralumab dose. The double‑blind, placebo‑controlled study enrolled 48 patients across eight U.S. sites and reported no serious safety issues. The company plans to present the full data at a scientific congress and discuss next steps with the FDA.
Why it matters
The company said the data provide encouraging evidence of biological activity in a disease with no approved therapies, which could support further development and potential regulatory engagement. However, the stock fell more than 13% after the announcement, reflecting market skepticism despite the positive trial outcomes.
Key facts
- 1The trial enrolled 48 patients across eight U.S. clinical sites. rttnews.com
- 2Patients received a 50 µg or 100 µg intranasal dose of foralumab or placebo for 12 weeks. rttnews.com
- 3The 50 µg dose showed a statistically significant reduction in microglial activation versus placebo (p=0.0168). rttnews.com
- 4The 50 µg group reduced fatigue scores by 6.17 points; the 100 µg group reduced fatigue by 7.18 points, both statistically significant. rttnews.com
- 5No deaths, drug‑related serious adverse events, or withdrawals due to adverse events were reported. rttnews.com
Open questions
- Material 4 reports the stock at $0.67 down 15.08%, while material 5 reports $0.69 down 13.44%.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.