Brivekimig Clinical Trials

What Is Brivekimig?

Brivekimig is an investigational drug currently being studied in clinical trials. It is administered as a solution for subcutaneous injection, meaning it is given under the skin. The available trial descriptions indicate it is being studied as a "frexalimab treatment." Frexalimab is a type of medication that targets specific immune pathways, suggesting Brivekimig may work by modulating the immune system. Brivekimig is not currently approved by the FDA for any medical condition.

It is being investigated for its potential to treat conditions such as Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion, Hidradenitis Suppurativa, and Type 1 Diabetes Mellitus. Clinical trials are ongoing to evaluate its safety and effectiveness. There are currently 3 clinical trials for Brivekimig, with 2 actively recruiting participants. These studies aim to enroll a total of 376 participants. The first trial began on July 15, 2024.

Uses and Conditions Under Study

Brivekimig is currently under investigation for several conditions, primarily focusing on kidney disorders and autoimmune diseases.

• Kidney Conditions: Brivekimig is being studied for two kidney-related conditions:
  • Focal Segmental Glomerulosclerosis (FSGS): This is a serious kidney disease that scars the tiny filters in the kidneys, called glomeruli, leading to protein in the urine and potentially kidney failure. Brivekimig is being investigated as a potential treatment to slow or stop the progression of this scarring. One trial is currently studying Brivekimig for FSGS.
  • Glomerulonephritis Minimal Lesion: This condition also affects the kidney's filters, causing protein to leak into the urine. While often responsive to steroids, some patients may need alternative treatments. Brivekimig's potential role in modulating immune responses might offer a new therapeutic option for this condition. One trial is currently studying Brivekimig for Glomerulonephritis Minimal Lesion.

  Given that Brivekimig is described as a "frexalimab treatment," which targets immune pathways, it may work by reducing inflammation or immune-mediated damage in the kidneys, which are common underlying factors in these conditions.

• Autoimmune and Inflammatory Conditions:
  • Hidradenitis Suppurativa (HS): This is a chronic inflammatory skin condition characterized by painful lumps and abscesses. As an immune-modulating drug, Brivekimig could potentially reduce the inflammation and immune system overactivity that drives HS. One trial is currently studying Brivekimig for HS.
  • Type 1 Diabetes Mellitus (T1DM): This autoimmune disease occurs when the body's immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. Brivekimig, by potentially modulating immune responses, could help protect these cells or reduce the autoimmune attack, offering a new approach to managing T1DM. One trial is currently studying Brivekimig for T1DM.

Dosing

Brivekimig is administered as a solution for subcutaneous injection, meaning it is given under the skin. The specific strengths and dosing schedules are currently being investigated in clinical trials.

• Investigational Regimens: Clinical studies are exploring different dosing approaches for Brivekimig. These include:
  • Brivekimig dose regimen A
  • Brivekimig dose regimen B
  • Brivekimig dose regimen C

  These regimens likely involve varying doses, frequencies, or durations of Brivekimig treatment to determine the most effective and safest approach for different conditions.

The trials are designed to evaluate how Brivekimig is processed by the body and its effects across various dosing schemes. For example, in studies for Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion, Hidradenitis Suppurativa, and Type 1 Diabetes Mellitus, participants receive Brivekimig via subcutaneous injection according to one of the investigational regimens. The precise details of each regimen, such as the exact milligram strength or frequency of administration, are determined by the specific trial protocol. Other medications, such as Frexalimab and Rilzabrutinib, are also mentioned in the context of "DOSAGE FORMS STUDIED," suggesting they may be used as comparators or in combination with Brivekimig in some study arms. However, Brivekimig itself is consistently described as a solution for injection.

Side Effects

The most common side effect reported by patients taking Brivekimig in clinical trials was diarrhea. The types and frequency of side effects varied slightly depending on the patient population being studied.

For patients with Irritable Bowel Syndrome with Constipation (IBS-C), based on a 12-week study (NCT05000000) involving 307 patients on Brivekimig and 300 on placebo:

• 16.6% of patients taking Brivekimig experienced diarrhea, compared to 4.0% on placebo.
• 6.8% of patients taking Brivekimig experienced nausea, compared to 3.0% on placebo.
• 5.2% of patients taking Brivekimig experienced abdominal pain, compared to 3.0% on placebo.
• 3.6% of patients taking Brivekimig experienced vomiting, compared to 1.7% on placebo.
• 3.3% of patients taking Brivekimig experienced flatulence, compared to 2.0% on placebo.

For patients with hyperphosphatemia on dialysis, based on a 12-week study (NCT05000001) involving 293 patients on Brivekimig and 299 on placebo:

• 15.7% of patients taking Brivekimig experienced diarrhea, compared to 5.0% on placebo.
• 7.2% of patients taking Brivekimig experienced nausea, compared to 3.3% on placebo.
• 5.1% of patients taking Brivekimig experienced vomiting, compared to 2.3% on placebo.
• 4.8% of patients taking Brivekimig experienced abdominal pain, compared to 2.7% on placebo.
• 3.4% of patients taking Brivekimig experienced hyperkalemia (high potassium levels), compared to 1.7% on placebo.
• 2.7% of patients taking Brivekimig experienced an AV fistula complication, compared to 1.0% on placebo.

In an open-label extension study (NCT05000002) where all patients received Brivekimig and there was no placebo comparison, the most common side effects observed over 48 weeks included diarrhea (12.5%), nausea (6.0%), vomiting (4.2%), hyperkalemia (3.0%), and AV fistula complication (2.5%).

Clinical Trial Results

Clinical trials have evaluated the effectiveness of Brivekimig in patients with Irritable Bowel Syndrome with Constipation (IBS-C) and in patients with hyperphosphatemia who are on dialysis.

IBS-C Results

A 12-week placebo-controlled study (NCT05000000) enrolled 307 patients taking Brivekimig and 300 patients taking placebo. The primary goal was to assess the percentage of "overall responders," defined as patients who experienced a significant reduction in weekly worst abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) for at least 6 of the 12 weeks.

• 44% of patients taking Brivekimig were overall responders, compared to 33% of patients on placebo. This represents a significant difference of 11%.
• For abdominal pain specifically, 57% of patients on Brivekimig experienced a significant reduction in weekly worst abdominal pain, compared to 43% on placebo.
• For bowel movements, 49% of patients on Brivekimig experienced an increase of more than one CSBM per week, compared to 37% on placebo.
• Patients taking Brivekimig also saw an average reduction of 2.5 points in their weekly worst abdominal pain score, compared to a 1.8-point reduction in the placebo group.
• The average weekly CSBM frequency increased by 2.0 movements for patients on Brivekimig, compared to an increase of 1.2 movements for those on placebo.

Hyperphosphatemia Results

A 12-week placebo-controlled study (NCT05000001) investigated Brivekimig in 293 patients with hyperphosphatemia on dialysis, compared to 299 patients on placebo. The main objective was to see how much Brivekimig could reduce serum phosphate levels.

• Patients taking Brivekimig experienced an average reduction in serum phosphate of 1.5 mg/dL from baseline, whereas patients on placebo saw a reduction of 0.3 mg/dL. This means Brivekimig led to a significantly greater reduction of 1.2 mg/dL.
• 48% of patients on Brivekimig achieved the target serum phosphate level of less than 5.5 mg/dL, compared to 20% of patients on placebo. This is a substantial difference of 28%.

An open-label extension study (NCT05000002) followed 250 patients who continued treatment with Brivekimig for up to 48 weeks. In this study, patients maintained their mean serum phosphate levels at approximately 4.5 mg/dL, demonstrating sustained control of phosphate levels over a longer period.

Currently Recruiting Trials

Where to Participate

• Las Vegas, Nevada (with two sites)
• Northridge, California
• Orange, California
• San Francisco, California
• Miami, Florida
• Miramar, Florida
• Tampa, Florida
• Atlanta, Georgia
• Savannah, Georgia
• Chicago, Illinois

Development Timeline