Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Foralumab TZLS-401 100 µg · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Subjects must have enrolled in and successfully completed TILS-021 within the preceding 90 days, including End of Treatment and End of Study assessments. * Screening clinical laboratory studies are within the normal ranges or within the parameters specified below, and clinical...
Foralumab TZLS-401 100 µg is an investigational small molecule antibody being developed for the treatment of Non-Active Secondary Progressive Multiple Sclerosis (SPMS). It is administered nasally and is currently in Phase 2 clinical development for this neurological condition.
Foralumab TZLS-401 100 µg is a monoclonal antibody (mab) that targets a specific molecular target involved in the immune response. As an antibody-based therapy, it is designed to modulate the immune system to potentially slow or halt the progression of Non-Active Secondary Progressive Multiple Sclerosis.
Foralumab TZLS-401 100 µg is developed by Tiziana Life Sciences Ltd, a biopharmaceutical company listed on the stock exchange under the ticker symbol TLSA. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for patients with Non-Active Secondary Progressive Multiple Sclerosis.
Foralumab TZLS-401 100 µg is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug has received Orphan Drug and Fast Track designations from the FDA, reflecting its potential to address an unmet medical need in Non-Active Secondary Progressive Multiple Sclerosis.
Foralumab TZLS-401 100 µg is being studied in a Phase 2 clinical trial with the identifier NCT06890923, titled 'Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis'. This trial is currently recruiting participants in the United States and aims to enroll 55 patients aged 18 years and older.
Yes, Foralumab TZLS-401 100 µg is the same drug as TZLS-401. The name 'Foralumab TZLS-401 100 µg' refers to the drug substance Foralumab at a dose of 100 micrograms, with TZLS-401 being the development code used by Tiziana Life Sciences Ltd for this investigational therapy.