Tiziana Life Sciences’ intranasal drug has hit the dual endpoints of a phase 2a study in patients with a form of multiple sclerosis (MS), although the win was slightly marred by the higher dose missing on a key neuroinflammation goal.
The London- and Boston-based biotech evaluated the anti-CD3 monoclonal antibody, called foralumab, in the mid-stage Inform-MS trial of 48 patients with non-active secondary progressive MS. Participants received either 50 μg or 100 μg doses of intranasal foralumab or placebo over 12 weeks.
PET scans of evaluable patients showed a 0.0231 reduction in white-matter/global-brain SUV ratio (SUVR) for the 50 μg cohort compared to placebo. This difference—which Tiziana described as statistically significant—hit one of the trial’s primary endpoints assessing neuroinflammation.
The 100 μg dose was less successful, however, failing to demonstrate a statistically significant difference in SUVR during the PET scans.
The win was more straightforward for the study’s other dual primary endpoint of safety, with all 48 participants completing treatment and no serious adverse events linked to foralumab. A total of 76.7% of patients across both doses of the study drug experienced treatment-emergent adverse events (TEAs) compared to 83.3% of the placebo cohort. The most common TEAs among foralumab patients were headache, fall, nasal congestion and rhinorrhea.
When it came to the trial’s secondary endpoint of fatigue as measured by the Modified Fatigue Impact Scale (MFIS) scores, the 50 ug cohort saw a 6.17-point decrease, while the 100 ug group saw a 7.18-point drop. With the placebo group seeing “no significant change,” Tiziana was able to point to this measure as a statistically significant improvement for its drug.
Another secondary endpoint, measured using the Expanded Disability Status Scale (EDSS), was unable to show a benefit for foralumab.
The company said in the Nov. 2 release that it plans to engage with the FDA to discuss the results and the “potential path forward for further clinical development of intranasal foralumab in na-SPMS.”
There are currently no FDA-approved therapies indicated specifically for na-SPMS, a form of the disease characterized by disability and symptoms slowly worsening over time without clinical relapses. This means there remains “a significant unmet need … particularly related to progressive disability and fatigue,” noted Tiziana.
The biotech’s CEO Ivor Elrifi said that 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 Alzheimer’s disease, amyotrophic lateral sclerosis, and multiple system atrophy, position us well as we advance foralumab to the next stage of development.”
The array of clinical trials for foralumab reflects Tiziana’s focus on the drug, after the company announced plans at the end of last year to spin out its interleukin-6 receptor candidate into a separate company.