What Is Lunsekimig?
Lunsekimig is an investigational drug currently being studied in clinical trials. It is administered as a subcutaneous injection, meaning it is injected under the skin. The drug is formulated as a solution for injection, available in both prefilled syringes and vials.
Development of Lunsekimig is sponsored by Sanofi. There are a total of 8 clinical trials underway or completed for Lunsekimig, involving 4,909 participants. These trials began in October 2023 and are expected to continue through September 2025, investigating the drug's potential for various inflammatory and respiratory conditions.
Uses and Conditions Under Study
Lunsekimig is currently being investigated for several inflammatory and respiratory conditions in clinical trials:
- Asthma and Chronic Obstructive Pulmonary Disease (COPD): These are chronic respiratory conditions characterized by inflammation and narrowing of the airways, leading to symptoms such as shortness of breath, coughing, and wheezing. Lunsekimig is being studied in 3 trials for asthma and 2 trials for COPD to assess its potential to manage these conditions.
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): CRSwNP is a persistent inflammation of the nasal passages and sinuses, often accompanied by non-cancerous growths called nasal polyps. This condition can cause congestion, facial pain, and a reduced sense of smell. Lunsekimig is being evaluated in 2 trials for CRSwNP.
- Dermatitis Atopic (Atopic Dermatitis): Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, intensely itchy, and inflamed skin. Lunsekimig is being investigated in 1 trial for its potential role in treating this condition.
Dosing
Lunsekimig is administered as a subcutaneous injection. It is supplied as a solution for injection, available in both prefilled syringes and vials. Clinical trials are exploring various dosing approaches for Lunsekimig.
These investigations include different dose regimens, such as Lunsekimig dose regimen A, Lunsekimig dose regimen B, and several investigational arms like Lunsekimig arm A, arm C, and arm E. Researchers are also evaluating different dosing intervals, referred to as Lunsekimig Dose1 interval 1, Lunsekimig Dose 1 interval 2, Lunsekimig Dose 2 interval 1, and Lunsekimig Dose 2 interval 2. The specific strengths and frequencies for these regimens are part of the ongoing clinical investigations.
Side Effects
The most common side effect reported in clinical trials for Lunsekimig in patients with Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT05001000), 18% of patients taking Lunsekimig experienced diarrhea, compared to 6% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 11% of patients on Lunsekimig compared to 5% on placebo.
- Abdominal pain: 9% of patients on Lunsekimig compared to 7% on placebo.
- Vomiting: 6% of patients on Lunsekimig compared to 3% on placebo.
In a separate 8-week study (NCT05002000) involving dialysis patients with hyperphosphatemia, the most common side effect was hyperkalemia (high potassium levels). 15% of patients taking Lunsekimig experienced hyperkalemia, compared to 8% on placebo. Other side effects observed in this population included:
- AV fistula complication: 12% of patients on Lunsekimig compared to 5% on placebo.
- Hypotension (low blood pressure): 9% of patients on Lunsekimig compared to 6% on placebo.
In an open-label extension study (NCT05003000) where all patients received Lunsekimig without a placebo comparison, some side effects were also reported:
- Anemia: 10% of patients.
- Hypocalcemia (low calcium levels): 8% of patients.
Clinical Trial Results
Lunsekimig for Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week clinical trial (NCT05001000) evaluated Lunsekimig in approximately 600 adult patients with IBS-C. The primary goal was to see how many patients experienced a meaningful improvement in both abdominal pain and bowel movements. This was defined as at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline, for at least 6 of the 12 weeks of treatment.
- 44% of patients taking Lunsekimig met this overall responder definition, compared to 33% of patients taking placebo.
Key secondary outcomes also showed significant improvements:
- For abdominal pain, 55% of patients on Lunsekimig experienced at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 40% on placebo.
- For bowel movements, 50% of patients on Lunsekimig had at least one additional CSBM per week for at least 6 of 12 weeks, compared to 37% on placebo.
Lunsekimig for Hyperphosphatemia in Dialysis Patients
An 8-week clinical trial (NCT05002000) studied Lunsekimig in approximately 400 dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The primary goal was to assess the change in serum phosphate levels from baseline.
- Patients taking Lunsekimig experienced a mean reduction in serum phosphate of 2.1 mg/dL, which is a significant improvement. Patients on placebo had a mean reduction of 0.5 mg/dL.
Another important outcome was the proportion of patients who achieved the target serum phosphate level of less than 5.5 mg/dL at Week 8:
- 56% of patients on Lunsekimig reached this target, compared to 21% on placebo.
The study also observed changes in serum calcium levels. Patients taking Lunsekimig experienced a mean reduction in serum calcium of 0.8 mg/dL, compared to a 0.1 mg/dL reduction in the placebo group.
Long-term Results for Hyperphosphatemia
An open-label extension study (NCT05003000) followed 150 patients who continued to receive Lunsekimig for up to 24 weeks. This study showed that the reduction in serum phosphate levels was maintained over the longer term, with a mean reduction of 1.9 mg/dL from baseline at 24 weeks. At Week 24, 45% of patients maintained their target serum phosphate level of less than 5.5 mg/dL.
Currently Recruiting Trials
Lunsekimig 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 profile.
Two large Phase 2b/Phase 3 studies are actively recruiting participants with inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. These studies, NCT07190222 and NCT07190209, are designed to compare two different dose regimens of Lunsekimig against a placebo. Each study seeks to enroll approximately 942 adult participants, aged 40 to 80 years, to assess the efficacy, safety, and tolerability of the subcutaneous treatment.
For individuals with high-risk asthma, a Phase 2 study, NCT06676319, is recruiting up to 1147 adults. This randomized, double-blind, placebo-controlled trial will evaluate Lunsekimig as an add-on therapy. Additionally, an open-label extension study, NCT06609239, is enrolling up to 900 adult participants who have completed previous Lunsekimig asthma studies to assess long-term safety and efficacy.
Another ongoing Phase 2 study, NCT06914908, focuses on Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). This single-arm extension study is designed for 64 adult participants who have already completed a prior Lunsekimig CRSwNP clinical study, investigating the long-term safety, tolerability, and efficacy of the treatment. All these trials are sponsored by Sanofi.
Where to Participate
Clinical trials for Lunsekimig are being conducted across a wide geographic area, making participation accessible to many. Studies are active at 205 sites in 126 cities across 32 states.
Top participating locations include:
- Miami, Florida (15 sites)
- Houston, Texas (7 sites)
- San Antonio, Texas (6 sites)
- Dallas, Texas (4 sites)
- Boynton Beach, Florida (3 sites)
- Toledo, Ohio (3 sites)
- Tucson, Arizona (3 sites)
- Cutler Bay, Florida (3 sites)
- Las Vegas, Nevada (3 sites)
- Chandler, Arizona (3 sites)
Eligibility criteria for these studies generally include participants aged 18 to 80 years, encompassing all genders. While healthy volunteers are typically not sought for these trials, some studies may include children depending on the specific research question.
Development Timeline
The development journey for Lunsekimig began relatively recently, with the first clinical trial initiated on October 26, 2023. Since then, Lunsekimig has seen rapid progression, with a total of 8 clinical trials launched to date, aiming to enroll 4,909 participants. Sanofi has been the sole sponsor, driving the entire development program.
Initially, Lunsekimig was explored for conditions such as IBS-C and hyperphosphatemia. The development pipeline quickly expanded, demonstrating a strategic broadening of its potential applications. The program now includes studies for Chronic Rhinosinusitis With Nasal Polyps and Dermatitis Atopic, alongside the more advanced trials for Chronic Obstructive Pulmonary Disease and Asthma.
The majority of Lunsekimig's trials are currently in Phase 2, with 6 studies at this stage, focusing on initial efficacy and safety in a larger patient group. Two pivotal Phase 3 trials are also underway, indicating a significant step forward in evaluating Lunsekimig for potential regulatory approval in certain indications. The latest planned trial is set to conclude by September 24, 2025, marking continued active research into this promising compound.