Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Foralumab Nasal
Foralumab · 5 trials · 8 indications
The occurrence of serious (inclusive of SUSARs) and non-serious treatment emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical, including vital signs (heart rate, blood pressure, weight) and laboratory values (reported as AEs) over both 12 (4 cycles) and 24 (8 cycles) week treatment periods in the Safety population.
the percentage of nasal foralumab treated participants in the Safety population who complete four (12-weeks) or eight (24-weeks) cycles of study treatment without study drug attributed intolerable AEs or SAEs or AESIs that lead to early permanent drug discontinuation.
The safety and tolerability of 50 µg/dose and 100 µg/doses of foralumab nasal as measured by adverse event reports
Assess change in baseline Modified Fatigue Impact Scale (MFIS) Scores range from 0-84. 0 is the minimum score and 84 is the maximum score. Lower scores indicate less fatigue while higher scores indicate increased fatigue.
The TNSS is the sum of scores over 24 hours and 2 weeks for nasal congestion, runny nose, nasal itching, sneezing, and difficulty sleeping. The TNSS is quantified using the following scale: None 0, Mild 1 (symptom clearly present but easily tolerated), Moderate 2 (symptom bothersome but tolerable), Severe 3 (symptom difficult to tolerate - interferes with activities).
Subjects at all sites will undergo PET imaging with the radiotracer \[18F\]PBR06.
Establish the safety of administration of nasal Foralumab to healthy volunteers in escalating doses for 5 consecutive days. Two or more serious adverse events occur that are possibly, probably or definitely related to nasal Foralumab.
Determine the dose at which immune effects are observed in subjects treated with Foralumab
| Arm | Type | Description |
|---|---|---|
| Foralumab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Foralumab Nasal | EXPERIMENTAL | This study includes a 6-month observational lead-in phase followed by a 6-month open-label treatment phase with Foralumab Nasal. |
| Nasal foralumab 50 μg per dosing day (25 μg per nostril) | EXPERIMENTAL | All patients will initially receive nasal foralumab 50 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles. |
| Nasal Foralumab 50 μg | EXPERIMENTAL | Each patient will receive nasal foralumab 50 μg per dosing day (25 μg per nostril). |
| Nasal Foralumab 100 μg | EXPERIMENTAL | Each patient will receive nasal foralumab 100 μg per dosing day (50 μg per nostril). |
| Nasal placebo (acetate buffer) | PLACEBO_COMPARATOR | Each patient will receive placebo on each dosing day in divided doses, in each nostril. |
| nasal foralumab 10 μg daily | EXPERIMENTAL | Group A: nasal foralumab 10 μg daily for 5 days |
| nasal foralumab 50 μg daily | EXPERIMENTAL | Group B: nasal foralumab 50 μg daily for 5 days |
| nasal foralumab 250 μg daily | EXPERIMENTAL | Group C: nasal foralumab 250 μg daily for 5 days |
| Name | Type | Description |
|---|---|---|
| Foralumab Nasal | DRUG | Foralumab is an anti-CD3 monoclonal antibody administered as a nasal spray. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab will be administered intranasally three times per week for the first two weeks, with no administration in the third week. |
| Placebo | DRUG | Foralumab placebo nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Participants will complete eight 3-week dosing cycles over the study. During each cycle, Foralumab placebo nasal solution will be administered intranasally three times per week for the first two weeks, with no administration in the third week. |
| Foralumab TZLS-401 100 µg | DRUG | Patients meeting the requirements of the dose escalation rules will receive nasal foralumab 100 µg three (3) days a week (Monday-Wednesday-Friday) for two weeks, followed by a one-week rest, comprising 3-week cycles. |
| Foralumab | DRUG | Foralumab nasal solution is a preservative-free, sterile, clear, colorless-to-slightly-yellow solution filled in an Aptar Unidose nasal atomizer device. Each Unidose device contains 0.13 mL foralumab placebo nasal solution, sufficient for administration to a single nare. Two Aptar Unidose devices will be used for a single dose (one device per nare). Each Unidose device contains foralumab nasal solution, supplied at either 25 μg foralumab or 50 μg foralumab, sufficient for administration into a single nare. |
Inclusion Criteria: * Adults ≥18 years of age and ≤75 years of age with a diagnosis of symptomatic ALS by revised El Escorial Criteria (clinically possible, probable, probable lab-supported, or definite). * Participant must be actively enrolled and must have met eligibility criteria for the Healey ...
Foralumab is an investigational monoclonal antibody given as a nasal formulation and developed for neurological conditions. It is being studied in amyotrophic lateral sclerosis, multiple system atrophy, and non-active secondary progressive multiple sclerosis. It is also known as Foralumab Nasal or Foralumab TZLS-401 100 µg, and it is in Phase 2 development.
Foralumab targets the CD3 epsilon, CD3 gamma, and CD3 delta chains of the CD3 complex, and it acts as an inhibitor. These CD3 chains are part of the T-cell receptor signaling complex. By binding these targets through a nasal route of administration, Foralumab is designed to modulate immune activity rather than deplete T cells systemically.
Foralumab is developed by Tiziana Life Sciences Ltd, which trades under the ticker TLSA. The company is advancing the nasal formulation of the antibody across several neurological indications, including amyotrophic lateral sclerosis, multiple system atrophy, and non-active secondary progressive multiple sclerosis.
Foralumab is in Phase 2 clinical development. It is investigational and is being evaluated in Phase 2 studies in amyotrophic lateral sclerosis, multiple system atrophy, and non-active secondary progressive multiple sclerosis, with an earlier Phase 1 safety and tolerability study in healthy volunteers already completed.
Foralumab is being studied in the Phase 2 BANYAN trial in ALS (NCT07688239), a Phase 2 trial in non-active secondary progressive multiple sclerosis (NCT06890923), and a Phase 2a study in multiple system atrophy (NCT06868628). A completed Phase 1 safety and tolerability study in healthy volunteers is registered as NCT06879067.