What Is Depemokimab?
Depemokimab is an investigational medication currently being studied in clinical trials. While the specific mechanism of action is not detailed in the provided trial descriptions, it is being investigated for its potential role in treating various inflammatory conditions. It is administered as a sterile liquid formulation.
Clinical trials are exploring depemokimab for conditions such as asthma, chronic obstructive pulmonary disease, and nasal polyps. It is also being studied for less common conditions like eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. A total of 13 trials have been conducted or are ongoing, with 5 trials currently recruiting participants. These studies have involved a total of 7,464 participants.
All clinical trials for depemokimab have been sponsored by GlaxoSmithKline.
Uses and Conditions Under Study
Depemokimab is being investigated for its potential to treat several inflammatory and respiratory conditions. These conditions often involve an overactive immune response or specific types of white blood cells called eosinophils.
- Asthma: Depemokimab is being studied in 6 trials for asthma. Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to symptoms like wheezing, shortness of breath, chest tightness, and coughing. Investigational treatments like depemokimab aim to reduce airway inflammation and improve lung function.
- Pulmonary Disease, Chronic Obstructive (COPD): This medication is also being explored in 3 trials for COPD, a progressive lung disease that causes obstructed airflow from the lungs. COPD includes conditions like emphysema and chronic bronchitis. Treatments often focus on managing symptoms and preventing exacerbations.
- Nasal Polyps: Depemokimab is under investigation in 2 trials for nasal polyps, which are noncancerous growths on the lining of the nasal passages or sinuses. These can cause symptoms such as nasal obstruction, loss of smell, and chronic sinusitis.
- Eosinophilic Granulomatosis With Polyangiitis (EGPA): This rare autoimmune disease, involving inflammation of small blood vessels and often affecting the lungs, skin, and nervous system, is being studied in 1 trial with depemokimab. EGPA is characterized by high levels of eosinophils.
- Hypereosinophilic Syndrome (HES): Another rare condition characterized by persistently elevated eosinophil counts in the blood and tissues, HES can affect multiple organ systems. Depemokimab is being studied in 1 trial for HES, aiming to reduce eosinophil levels and prevent organ damage.
Dosing
Depemokimab is administered as a sterile liquid formulation. Clinical trials have explored different methods for administering the medication.
Participants in studies have received depemokimab via a Single-Shot Device (SSD) or an autoinjector. These administration methods are designed for convenient delivery of the medication. The specific strengths or frequencies of administration (e.g., daily, weekly, monthly) are not detailed in the provided trial data.
In some studies, depemokimab has been administered alongside a placebo matching another medication, mepolizumab, or as a placebo matching prior anti-IL-5/5R treatments. This approach helps researchers understand the specific effects of depemokimab compared to other treatments or no active treatment.
Side Effects
In clinical trials, the most common side effects reported by patients taking Depemokimab were:
- Nasopharyngitis (common cold symptoms): 14.5% of patients taking Depemokimab experienced this, compared to 14.0% on placebo.
- Upper respiratory tract infection: 10.4% of patients taking Depemokimab experienced this, compared to 11.4% on placebo.
- Nasal polyps: 5.5% of patients taking Depemokimab reported nasal polyps, compared to 7.4% on placebo.
- Headache: 5.0% of patients taking Depemokimab experienced this, compared to 6.4% on placebo.
- Bronchitis: 4.9% of patients taking Depemokimab experienced this, compared to 3.4% on placebo.
- Rhinitis (inflammation of the nasal lining): 4.2% of patients taking Depemokimab experienced this, compared to 5.3% on placebo.
- Sinusitis (sinus inflammation): 4.1% of patients taking Depemokimab experienced this, compared to 5.0% on placebo.
- Respiratory tract infection: 3.6% of patients taking Depemokimab experienced this, compared to 2.6% on placebo.
These side effects were observed across multiple clinical trials involving up to 941 patients treated with Depemokimab.
Clinical Trial Results
Depemokimab for Severe Asthma with Eosinophilic Phenotype
A 52-week placebo-controlled study (NCT04719832) evaluated Depemokimab in participants with severe asthma with an eosinophilic phenotype. Key findings included:
- Patients treated with Depemokimab experienced an average of 0.46 exacerbations per year, compared to 1.11 exacerbations per year for those on placebo. This represents a 60% reduction in clinically significant asthma exacerbations.
- Exacerbations requiring hospitalization or an emergency department visit were also significantly reduced. There were 5 such exacerbations in the Depemokimab group, compared to 13 in the placebo group, a 62% reduction.
- Patients on Depemokimab showed greater improvement in asthma-related quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, with an average reduction of 13.03 points, compared to 9.67 points for placebo. A larger reduction indicates better quality of life.
An open-label extension study (NCT05243680) followed participants who had completed the previous studies. For those who continued on Depemokimab, the annualized rate of clinically significant exacerbations remained low at 0.55 per year. Participants who had previously received placebo and then switched to Depemokimab experienced a reduced annualized exacerbation rate of 0.58 per year, showing improvement after starting the treatment.
Depemokimab for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Two studies, NCT05274750 and NCT05281523, assessed the efficacy and safety of Depemokimab in patients with CRSwNP over 52 weeks. The results demonstrated improvements in several key areas:
- Patients treated with Depemokimab saw a reduction in the size and number of nasal polyps, with endoscopic nasal polyps scores decreasing by 0.5 to 0.6 points across the studies, compared to a slight increase (0.1 to 0.2 points) in the placebo group.
- Overall sinonasal symptoms, as measured by the Sino-nasal Outcome Test (SNOT)-22, improved significantly. Depemokimab led to an average symptom score reduction of 13.3 to 15.9 points, whereas placebo resulted in a reduction of 6.0 to 6.5 points. A larger reduction signifies better symptom control.
- Fewer patients on Depemokimab required systemic corticosteroids or disease-modifying medication for CRSwNP, or nasal surgery. 26% of patients on Depemokimab required such interventions, compared to 36% on placebo, representing a 28% reduction.
- Specifically, the need for first nasal surgery or disease-modifying medication was lower in the Depemokimab group (12.2%) compared to the placebo group (16.7%), a 27% reduction.
- Imaging results also showed improvement, with Lund Mackay Computed Tomography (CT) scores, which measure inflammation and disease severity, decreasing by 2.8 to 3.5 points for Depemokimab patients, compared to 0.3 to 0.8 points for placebo.
- Patients on Depemokimab also experienced greater improvements in nasal obstruction (average reduction of 0.74 to 0.78 points vs. 0.53 to 0.57 points for placebo) and loss of smell (average reduction of 0.48 to 0.56 points vs. 0.29 to 0.30 points for placebo).
Currently Recruiting Trials
Several clinical trials are currently seeking participants to further evaluate Depemokimab for various conditions. These studies aim to understand the efficacy and safety of this investigational treatment.
For individuals with Chronic Obstructive Pulmonary Disorder (COPD) with type 2 inflammation, there are three Phase 3 studies. The "eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation" trial, identified as NCT07177339, is assessing depemokimab as an early add-on therapy and aims to enroll 1196 participants. Two other Phase 3 trials, "Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2)" (NCT06961214) and "(ENDURA -1)" (NCT06959095), are investigating depemokimab as an extended treatment duration biologic. These studies are targeting enrollments of 960 and 981 participants, respectively, to evaluate depemokimab as an add-on medicine for uncontrolled moderate to severe COPD with type 2 inflammation.
Another Phase 3 study, "Depemokimab Asthma Imaging and Bronchoscopy Sub-Study" (NCT06979323), is recruiting 150 participants with asthma. This trial focuses on how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic individuals.
Finally, the "Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial" (NCT05334368) is a Phase 3 study for adults with uncontrolled Hypereosinophilic Syndrome (HES). This randomized, placebo-controlled trial plans to enroll 123 participants to assess the efficacy and safety of depemokimab when added to standard of care therapy.
Where to Participate
Clinical trials for Depemokimab are currently recruiting participants across a wide geographic area, with study sites located in 65 cities across 24 states. The majority of these sites are concentrated in Florida, with additional locations in other states.
Top recruiting locations include:
- Miami, Florida (8 sites)
- Doral, Florida (2 sites)
- Brooksville, Florida (2 sites)
- Aurora, Colorado (1 site)
- Fort Lauderdale, Florida (1 site)
- Loxahatchee Groves, Florida (1 site)
- Naples, Florida (1 site)
- Adairsville, Georgia (1 site)
- Cordele, Georgia (1 site)
- New Port Riche, Florida (1 site)
To be eligible for participation in these studies, individuals must generally be between 18 and 80 years of age. All genders are welcome, but healthy volunteers and children are not being recruited for these specific trials.
Development Timeline
The journey of Depemokimab began with its first clinical trial on January 22, 2021, marking the start of its development as a potential new therapy. From the outset, GlaxoSmithKline has been the sole sponsor, driving the research and development efforts for this investigational drug.
Initially, depemokimab was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline expanded significantly, reflecting a growing understanding of the drug's potential. The focus broadened to include other conditions, such as Nasal Polyps, Eosinophilic Granulomatosis With Polyangiitis, and Hypereosinophilic Syndrome.
The development program has progressed rapidly, with a total of 13 trials conducted to date, involving a substantial enrollment of 7,464 participants. The majority of these studies, 12 out of 13, have advanced to Phase 3, indicating a mature stage of clinical investigation. Only one trial remains in Phase 1. The latest projected completion date for a trial is March 6, 2026, demonstrating ongoing commitment to thoroughly evaluate depemokimab's safety and efficacy.