Approval Probability
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Also known as Foralumab Nasal
Foralumab · 4 trials · 7 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 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 | 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 | 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 drug being studied for Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, and ALS (Amyotrophic Lateral Sclerosis). It is also being evaluated in a safety study in healthy volunteers. Foralumab is in Phase 2 clinical development for these neurological conditions.
Foralumab targets CD3E, CD3G, and CD3D, which are components of the CD3 T-cell receptor complex. It acts as an inhibitor of these molecular targets. By inhibiting CD3, Foralumab is designed to modulate T-cell activity, which is relevant to the autoimmune and neurodegenerative conditions being studied.
Foralumab is being developed by Tiziana Life Sciences Ltd, a biopharmaceutical company. The company's stock is listed under the ticker symbol TLSA. Tiziana Life Sciences is conducting clinical trials of Foralumab in the United States for multiple neurological indications.
Foralumab is in Phase 2 clinical development. It has received Orphan Drug and Fast Track designations from the FDA. Foralumab is investigational and has not been approved by the FDA. It is being studied in Phase 2 trials for Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, and ALS.
Foralumab is being studied in several clinical trials. NCT06292923 is a Phase 2 study in non-active Secondary Progressive Multiple Sclerosis with 54 participants. NCT06868628 is a Phase 2a study in Multiple System Atrophy with 5 participants. NCT06879067 is a completed Phase 1 safety study in healthy volunteers. NCT07688239 is a Phase 2 trial in ALS with 44 participants.
Yes, Foralumab is also known as Foralumab Nasal. The drug is administered via the nasal route, as indicated by the name. Clinical trials of Foralumab Nasal are being conducted for conditions such as Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, and ALS.