Photo: Tiziana Life Sciences (archive photo)
Tiziana Life Sciences said Monday, November 2, that the lower dose of its experimental nasal antibody foralumab reduced a PET imaging measure of neuroinflammation in a small multiple sclerosis trial. The higher dose did not show a statistically significant imaging benefit, and neither dose produced improvement on the study’s disability measure.
The company’s topline announcement covered 48 patients with non-active secondary progressive multiple sclerosis in the randomized, double-blind, placebo-controlled Phase 2a INFORM-MS trial. Patients received treatment for 12 weeks. Foralumab remains an investigational treatment, not an approved medicine.
The 50-microgram dose met the neuroinflammation endpoint compared with placebo, with a reported p-value of 0.0168. The endpoint used TSPO PET scans to measure microglial activation, an imaging marker of inflammatory activity. The analysis included 40 participants with analyzable PET scans. The 100-microgram dose did not show a statistically significant PET difference.
Fatigue findings need careful interpretation
Tiziana reported that fatigue scores improved from patients’ own starting scores in both treatment groups. On the Modified Fatigue Impact Scale, the mean change was minus 6.17 points with 50 micrograms, minus 7.18 with 100 micrograms and minus 3.12 with placebo. The reported statistical significance for fatigue was against each treatment group’s own baseline, not a demonstrated placebo-adjusted benefit.
The company said the trial was not powered to establish definitive changes in clinical measures such as fatigue. It reported no change in the Expanded Disability Status Scale secondary endpoint over the three-month treatment period. A positive imaging result therefore should not be read as proof that the treatment reverses disability or slows its progression.
All 48 participants completed treatment. Tiziana said both doses were well tolerated, with no deaths, no discontinuations because of adverse events and no study-drug-related serious adverse events. Common reported events included headache, falls, nasal congestion and runny nose. Those findings come from a small, short-duration study and do not establish long-term safety.
The trial enrolled patients at eight U.S. sites: 19 received the 50-microgram dose, 11 received 100 micrograms and 18 received placebo. Dosing took place in four consecutive three-week cycles.
Non-active secondary progressive MS involves gradual accumulation of disability without recent relapses or new MRI activity, according to the company. Foralumab is a fully human anti-CD3 monoclonal antibody delivered as a nasal spray.
Tiziana plans to finish analyzing the data, present detailed results at a scientific congress and discuss further clinical development with the U.S. Food and Drug Administration. Monday’s announcement does not represent regulatory approval or establish that foralumab is an effective treatment for patients outside research settings.
JBizNews Desk | New York
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