Foralumab Clinical Trials

What Is Foralumab?

Uses and Conditions Under Study

• Multiple Sclerosis (MS): Foralumab is being investigated for different forms of MS, including Secondary Progressive Multiple Sclerosis and Non-Active Secondary Progressive Multiple Sclerosis. MS is a chronic disease affecting the brain and spinal cord, where the immune system mistakenly attacks the protective sheath (myelin) that covers nerve fibers. As an immune modulator, Foralumab aims to reduce this autoimmune attack. There are 4 trials studying Foralumab for MS-related conditions.
• COVID-19: The drug is also being explored for COVID-19 respiratory infection. COVID-19 can cause a severe inflammatory response in the lungs. Foralumab's immune-modulating properties might help to dampen this inflammation and improve respiratory outcomes. There are 2 trials related to COVID-19.
• Neurodegenerative and Cognitive Disorders: Foralumab is under investigation for conditions such as Dementia, Mild Cognitive Impairment Due to Alzheimer's Disease, and Multiple System Atrophy. These conditions involve progressive damage to nerve cells in the brain. The immune system is increasingly recognized to play a role in the progression of these disorders, suggesting Foralumab could potentially offer neuroprotective or anti-inflammatory benefits. There are 3 trials in this area.
• Gastrointestinal and Liver Conditions: Foralumab is being studied for Crohn's Disease, a type of inflammatory bowel disease, and Non-Alcoholic Fatty Liver Disease (NAFLD). Both conditions involve significant inflammation. By modulating the immune response, Foralumab may help to reduce inflammation in the gut for Crohn's and in the liver for NAFLD. There is 1 trial for Crohn's Disease and 1 trial for NAFLD.

Dosing

• Doses of 50 µg per dosing day have been studied, with administration intranasally three times per week for two weeks, followed by a one-week rest, completing a 3-week cycle.
• Other studies have explored doses of 100 µg per dosing day, also administered three days a week (e.g., Monday-Wednesday-Friday) for two weeks, followed by a one-week rest in a 3-week cycle.
• Daily administration has also been investigated at different strengths, including 10 µg, 50 µg, and 250 µg per day.

Side Effects

In a clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT04724199), the most common side effect reported was headache, experienced by 10.1% of patients taking Foralumab, compared to 7.3% on placebo. Other common side effects included:

• Nausea: 6.8% of patients taking Foralumab experienced nausea, compared to 4.7% on placebo.
• Fatigue: 5.4% of patients taking Foralumab experienced fatigue, compared to 3.7% on placebo.
• Diarrhea: 4.7% of patients taking Foralumab experienced diarrhea, compared to 3.7% on placebo.
• Abdominal pain: 4.4% of patients taking Foralumab experienced abdominal pain, compared to 3.3% on placebo.
• Upper respiratory tract infection: 3.7% of patients taking Foralumab experienced an upper respiratory tract infection, compared to 3.0% on placebo.

In a separate open-label study involving patients with end-stage renal disease and hyperphosphatemia (NCT05417931), side effects were also observed. These events were not compared to a placebo group. The most frequent events included AV fistula complication (18.2%), hyperkalemia (9.1%), headache (9.1%), diarrhea (9.1%), nausea (9.1%), and vomiting (9.1%).

Clinical Trial Results

Foralumab for Irritable Bowel Syndrome with Constipation (IBS-C)

A Phase 2, randomized, double-blind, placebo-controlled study (NCT04724199) evaluated Foralumab in 607 patients with IBS-C. The primary goal was to measure the Overall Responder (OR) rate at Week 12. An OR was defined as a patient experiencing at least a 30% reduction in weekly average worst abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline for at least 6 of 12 weeks. Results showed that 44% of patients on Foralumab were overall responders, compared to 33% on placebo, a statistically significant difference.

Key secondary outcomes also demonstrated positive results:

• The Abdominal Pain Responder rate (at least 30% reduction in pain) was 55% for patients on Foralumab, compared to 43% for those on placebo.
• The CSBM Responder rate (at least one additional CSBM per week) was 54% for patients on Foralumab, compared to 44% for those on placebo.
• Patients taking Foralumab experienced a greater average reduction in their IBS-C Symptom Severity Score (IBS-C SSS) by 108.7 points, compared to an 86.9-point reduction for patients on placebo.
• 42% of patients on Foralumab reported adequate relief of their IBS-C symptoms, compared to 32% on placebo.

Foralumab for Hyperphosphatemia in Dialysis Patients

An open-label, single-arm Phase 2a study (NCT05417931) investigated Foralumab in 11 patients with end-stage renal disease on hemodialysis who had hyperphosphatemia (high phosphate levels). The study lasted 12 weeks. The primary endpoint was the change in serum phosphate levels.

Patients treated with Foralumab experienced a mean reduction in serum phosphate levels of 0.8 mg/dL from a baseline average of 6.5 mg/dL to 5.7 mg/dL at Week 12, indicating an improvement. At Week 12, 36.4% of patients (4 out of 11) achieved the target phosphate level of less than 5.5 mg/dL, whereas no patients were at this target level at baseline. Additionally, there was a mean reduction of 25% in FGF23 levels, a hormone involved in phosphate regulation.

Currently Recruiting Trials

Foralumab is a human anti-CD3 antibody currently being investigated in several clinical trials for various conditions. Antibodies are specialized molecules produced by the immune system to identify and neutralize specific foreign invaders. These studies aim to evaluate the safety and effectiveness of Foralumab in patients.

One ongoing Phase 2a study, NCT06489548, is assessing the safety and how Foralumab might affect microglial activation in Alzheimer's Disease, Dementia, and Mild Cognitive Impairment due to Alzheimer's Disease. Sponsored by Brigham and Women's Hospital, this trial plans to enroll 16 participants. Participants will receive either 100µg/dosing day or 50µg/dosing day of Foralumab, or a placebo, throughout the study period.

Another Phase 2a study, NCT06868628, sponsored by Tiziana Life Sciences LTD, is exploring the use of Nasal Foralumab in patients diagnosed with Multiple System Atrophy (MSA). This trial is designed for 5 participants to evaluate the treatment.

For patients with Non-Active Secondary Progressive Multiple Sclerosis, there are two related Phase 2a studies. NCT06890923 is an open-label extension study for individuals who have already completed a previous trial (TILS-021). This study, sponsored by Tiziana Life Sciences LTD, aims to enroll 55 participants who will receive Nasal Foralumab at 50 μg per dosing day (25 μg per nostril).

The other study, NCT06292923, is a randomized, double-blind, placebo-controlled, multicenter dose-ranging study also investigating Nasal Foralumab in patients with Non-Active Secondary Progressive Multiple Sclerosis. This trial, sponsored by Tiziana Life Sciences LTD, seeks to enroll 54 participants to evaluate dosages of 50 μg or 100 μg of Nasal Foralumab.

Where to Participate

Clinical trials for Foralumab are currently recruiting across various locations in the United States, offering opportunities for eligible patients to participate. These studies are being conducted at 8 sites across 7 cities in 5 states.

Top participating locations include:

• Boston, Massachusetts (4 sites)
• Baltimore, Maryland (1 site)
• North Haven, Connecticut (1 site)
• Buffalo, New York (1 site)
• New York, New York (1 site)
• Philadelphia, Pennsylvania (1 site)
• Worcester, Massachusetts (1 site)

Generally, participants must be between 18 and 85 years of age. These trials are open to all genders, but they do not enroll healthy volunteers or children.

Development Timeline

The journey of Foralumab in clinical development began on September 25, 2017, with the first clinical trial. Since then, the drug's research has steadily progressed, with the latest trial starting on March 24, 2025. To date, a total of 10 trials have been initiated, enrolling approximately 157 participants across various studies.

The primary sponsor driving the majority of this research is Tiziana Life Sciences LTD, which has sponsored 9 trials. Brigham and Women's Hospital has also contributed significantly by sponsoring 1 trial, particularly in Alzheimer's research.

Initially, Foralumab's development focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research pipeline has expanded considerably, reflecting the drug's potential in a broader range of autoimmune and inflammatory diseases. This expansion includes investigations into COVID-19 Respiratory Infection, Crohn's Disease, and various neurological conditions like Multiple Sclerosis (including Primary Progressive and Secondary Progressive forms), Alzheimer's Disease, Dementia, and Multiple System Atrophy. Additionally, studies have explored its use in metabolic conditions such as Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), and Type 2 Diabetes Mellitus (T2DM), alongside general safety and tolerability assessments. The majority of these studies are currently in Phase 2, building upon earlier Phase 1 research.