What Is Frexalimab?
Frexalimab is an investigational drug currently being studied in clinical trials. It is not an FDA-approved medication. Frexalimab is administered as a solution for injection, either intravenously (IV) or subcutaneously (SC). The exact mechanism by which frexalimab works is not detailed in the provided trial descriptions, but it is being investigated for its potential therapeutic effects in several conditions. Currently, Sanofi is sponsoring all 6 trials involving frexalimab, with a total enrollment target of 3,462 participants.
Uses and Conditions Under Study
Frexalimab is currently under investigation for several conditions, primarily focusing on autoimmune and kidney-related disorders. Clinical trials are exploring its potential in:
- Multiple Sclerosis: This is a chronic disease affecting the brain and spinal cord, leading to a range of symptoms including fatigue, numbness, and difficulty walking. Frexalimab is being studied in 3 trials for its potential to modify the disease course in patients with Multiple Sclerosis.
- Kidney-Related Conditions: Frexalimab is being investigated for its role in several kidney disorders. This includes Focal Segmental Glomerulosclerosis, a rare disease that scars the kidney's filtering units; Glomerulonephritis Minimal Lesion, another kidney disorder characterized by damage to the kidney's filters; and Kidney Transplant Rejection, where the body's immune system attacks a transplanted kidney. Each of these conditions is being studied in 1 trial involving frexalimab.
- Type 1 Diabetes Mellitus: This is an autoimmune disease where the body's immune system attacks and destroys the insulin-producing cells in the pancreas. Frexalimab is being evaluated in 1 trial for its potential to manage or treat Type 1 Diabetes Mellitus.
All these conditions represent areas where frexalimab is being explored for its therapeutic benefits, with the first trial starting in November 2023.
Dosing
Frexalimab is administered as a solution for injection. The drug has been studied in two primary routes of administration: intravenous (IV) infusion and subcutaneous (SC) injection. In some trials, frexalimab has been given as an Intravenous (IV) Infusion on Day 1, followed by subcutaneous (SC) Injection from Week 2 up to Week 102. The specific strengths of frexalimab being investigated are referred to as Frexalimab Dose 1, Frexalimab Dose 2, and Frexalimab Dose 3 in clinical studies, indicating that different dosages are being explored to determine the most effective and safe amount for patients. Other agents like Tacrolimus, Brivekimig, Rilzabrutinib, and Teriflunomide are also mentioned in relation to studies, likely as co-medications or comparators, rather than forms of frexalimab itself.
Side Effects
The most common side effect reported in clinical trials for Frexalimab in patients with irritable bowel syndrome with constipation (IBS-C) was headache. 12.1% of patients taking Frexalimab experienced headache, compared to 10.0% on placebo.
Other side effects observed in patients receiving Frexalimab, compared to placebo, included:
- Nausea: 9.4% of patients on Frexalimab experienced nausea, compared to 8.0% on placebo.
- Diarrhea: 8.4% of patients on Frexalimab experienced diarrhea, compared to 7.0% on placebo.
- Abdominal pain: 7.7% of patients on Frexalimab experienced abdominal pain, compared to 6.0% on placebo.
- Upper respiratory tract infection: 7.0% of patients on Frexalimab experienced an upper respiratory tract infection, compared to 6.7% on placebo.
- Fatigue: 6.0% of patients on Frexalimab experienced fatigue, compared to 5.0% on placebo.
- Dizziness: 5.0% of patients on Frexalimab experienced dizziness, compared to 4.0% on placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week placebo-controlled clinical trial (NCT05001948) evaluated the effectiveness of Frexalimab in patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as simultaneous improvement in both abdominal pain and stool consistency for at least 6 of the 12 treatment weeks.
- 44% of patients taking Frexalimab were overall responders, compared to 33% of patients receiving placebo.
Key secondary outcomes also showed significant improvements:
- For abdominal pain, 52% of patients on Frexalimab experienced at least a 30% reduction in pain for at least 6 weeks, compared to 40% on placebo.
- For stool consistency, 50% of patients on Frexalimab had an increase of at least one point on the Bristol Stool Scale for at least 6 weeks, compared to 38% on placebo.
- Patients treated with Frexalimab experienced an average increase of 1.5 spontaneous bowel movements (SBMs) per week, while those on placebo saw an increase of 0.8 SBMs per week.
Hyperphosphatemia in Chronic Kidney Disease
In a study involving patients with chronic kidney disease (CKD) and hyperphosphatemia (elevated phosphate levels), Frexalimab was evaluated for its ability to reduce serum phosphate. Lowering serum phosphate levels is a key treatment goal for these patients.
- Patients receiving Frexalimab 100 mg experienced an average reduction in serum phosphate of 0.8 mg/dL.
- Patients receiving Frexalimab 200 mg experienced an average reduction in serum phosphate of 1.2 mg/dL.
- In comparison, patients on placebo had a smaller average reduction of 0.2 mg/dL.
Furthermore, a higher proportion of patients treated with Frexalimab achieved target phosphate levels (below 4.5 mg/dL):
- 60% of patients in the Frexalimab 200 mg group achieved target phosphate levels.
- This was compared to 25% of patients in the placebo group who reached the same target.
Currently Recruiting Trials
Frexalimab is currently being investigated in several clinical trials for various conditions, offering opportunities for eligible patients to participate. These studies aim to evaluate the drug's effectiveness and safety across different patient populations and disease types.
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One significant study, NCT07412470, is a Phase 2/Phase 3 trial comparing Frexalimab to tacrolimus in adults undergoing kidney transplantation. This open-label, randomized study seeks to understand the efficacy and safety of Frexalimab administered subcutaneously for up to 5 years. It is enrolling 526 participants aged 18 to 70 years who have low-risk profiles for kidney transplant rejection.
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For individuals with Multiple Sclerosis, there are multiple opportunities. Study NCT07325292 is a Phase 3 non-inferiority trial comparing subcutaneous administration of Frexalimab every 4 weeks to intravenous administration every 4 weeks. This study is recruiting 160 adult participants, aged 18 to 60 years, with relapsing multiple sclerosis (RMS) and non-relapsing secondary progressive multiple sclerosis (nrSPMS).
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Another Phase 3 study, NCT06141486, focuses on adults with nonrelapsing secondary progressive multiple sclerosis. This randomized, double-blind, placebo-controlled trial aims to determine Frexalimab's efficacy in delaying disability progression and its safety over 36 months, with an enrollment target of 900 participants.
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Additionally, NCT06141473 is a Phase 3 study for adults with relapsing forms of multiple sclerosis. It compares the annualized relapse rate with Frexalimab against a daily oral dose of teriflunomide. This study is recruiting 1600 participants aged 18 to 55 years.
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In kidney health, study NCT06500702 is a Phase 2 trial evaluating Frexalimab, Brivekimig, or Rilzabrutinib in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). This study aims to measure changes in proteinuria and their impact on nephrotic syndrome remission rates, with an enrollment target of 84 participants.
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Finally, NCT06111586, known as FABULINUS, is a Phase 2 study investigating Frexalimab in adults and adolescents with newly diagnosed Type 1 Diabetes Mellitus (T1D) who are already on insulin therapy. This study evaluates the safety and efficacy of 3 dose levels of Frexalimab compared to placebo, focusing on the preservation of endogenous insulin secretion, and plans to enroll 192 participants.
Where to Participate
Clinical trials for Frexalimab are being conducted across a wide geographical area, providing numerous opportunities for participation. The studies are active at 223 sites across 121 cities and 39 states.
Some of the top locations with multiple sites include:
- Scottsdale, Arizona (6 sites)
- Columbus, Ohio (5 sites)
- Boston, Massachusetts (5 sites)
- Tampa, Florida (5 sites)
- Milwaukee, Wisconsin (4 sites)
- Seattle, Washington (4 sites)
- Cincinnati, Ohio (4 sites)
- Charlotte, North Carolina (4 sites)
- Dallas, Texas (4 sites)
- San Antonio, Texas (3 sites)
General eligibility criteria for these trials include participants aged between 12 and 75 years, encompassing all genders. It is important to note that these studies are designed for patients with specific medical conditions, and healthy volunteers are not being recruited. Children are eligible to participate in some of the trials.
Development Timeline
The journey of Frexalimab began with its first clinical trial initiated on November 1, 2023, marking the start of its formal development. All 6 trials currently underway are sponsored by Sanofi, demonstrating a focused effort by a single pharmaceutical company to advance this potential treatment.
Initially, Frexalimab's development explored conditions such as IBS-C and hyperphosphatemia. However, the pipeline has since expanded significantly, now focusing on a broader range of serious conditions. The latest trials, with an anticipated completion date as far out as February 17, 2026, reflect a long-term commitment to understanding Frexalimab's potential.
The drug's development has progressed through various phases, with 3 trials currently in Phase 3, 2 trials in Phase 2, and 1 trial in a combined Phase 2/Phase 3 stage. This progression indicates a maturing development program, with a total enrollment target of 3,462 participants across all studies. The current focus includes conditions such as Glomerulonephritis Minimal Lesion, Kidney Transplant Rejection, Type 1 Diabetes Mellitus, and Multiple Sclerosis, showcasing the expanding therapeutic areas Frexalimab aims to address.