Tiziana registers nasal foralumab ALS trial with no placebo control listed
The 44-patient BANYAN study will test safety and microglial biomarkers within the Healey ALS Platform, not efficacy, and no primary endpoint or competitor has ever tested this CD3 agonist in ALS.
Executive Summary
- Tiziana Life Sciences LTD registered a new Phase 2 trial, BANYAN (NCT07688239), testing nasally administered foralumab in 44 ALS patients through the Healey ALS Platform's MyMatch structure, with a primary completion date of July 1, 2027.
- The registered primary endpoints measure safety and tolerability over 12 and 24 weeks, not efficacy, so the 2027 data will not establish whether foralumab slows ALS progression.
- No CD3-targeted therapy has ever completed a trial in ALS; historical outcomes for foralumab in this indication show zero completed, terminated, or withdrawn studies.
- Tiziana has completed only 2 of 4 prior trials globally, a 50% completion rate, with 2 terminations on record, a factor that weighs on execution confidence for this new study.
- The Healey Platform's pre-screened, biomarker-selected population (neurofilament light above 40 pg/mL) gives BANYAN faster access to eligible patients than a standalone trial would, but the study still needs to clear enrollment and dosing before any biomarker signal emerges.
The registration
Tiziana Life Sciences LTD listed a new ALS trial on ClinicalTrials.gov: the BANYAN Trial, evaluating safety, biomarker activity, and microglial activation of nasally dosed foralumab. The study, NCT07688239, is a Phase 2, interventional trial with an anticipated enrollment of 44 patients and a primary completion date of July 1, 2027. The trial has not started recruiting; its planned start date is July 25, 2026. It runs inside the Healey ALS Platform Trial's MyMatch Common Screening Protocol, which pre-screens ALS patients against a shared eligibility bar before assigning them to individual sub-studies.
What the trial can prove
The registered primary outcome measures are safety, defined as the occurrence of serious and non-serious treatment-emergent adverse events over 12 and 24 weeks, and tolerability, the percentage of participants completing four or eight treatment cycles without drug-related discontinuation. Neither is an efficacy endpoint. Secondary measures include changes in blood and CSF neurofilament light, a marker of neurodegeneration, and immune reconstitution markers such as regulatory T cell counts and gene expression by single-cell RNA sequencing. A 2027 readout will show whether the drug is tolerated and whether it moves these biomarkers, not whether it changes ALS progression.
Eligibility and design
Enrollment requires a blood neurofilament light level above 40 pg/mL, ALS onset within 24 months, and slow vital capacity of at least 65% predicted, a narrower population than a general ALS trial would use. The registry lists a placebo search term in the competitive database, but the trial record itself does not confirm randomization structure, arm sizes, or blinding. ClinicalTrials.gov has no results posted for this study, consistent with a trial that has not yet started recruiting.
No mechanism precedent
No CD3-targeted therapy has ever completed a trial in ALS. A search across completed, terminated, and withdrawn ALS trials for foralumab, CD3, and Phase 2 status returns zero results. The nearest modality precedent is siplizumab, a CD2-targeted monoclonal antibody in a Phase 1 ALS trial (NCT06453668), which shares indication and modality but targets a different antigen. CD3-targeted bispecific antibodies such as teclistamab, epcoritamab, and elranatamab are active mostly in multiple myeloma and lymphoma, a different modality (T-cell engaging bispecifics) and disease context, so they inform CD3 biology broadly but are not direct competitors for this indication.
Sponsor execution history
Tiziana Life Sciences LTD has completed 2 of 4 trials tracked globally, a 50% completion rate, with 2 terminations on record. That history matters because BANYAN's small size (44 patients) and reliance on a shared screening protocol still depend on Tiziana's own execution to reach the 2027 primary completion date. The trial's protocol stability reading shows zero change events since its registration on July 7, 2026, but that reflects a single day of registry history rather than a track record of amendment discipline.
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