Verekitug Clinical Trials

What Is Verekitug?

Verekitug is an investigational drug, also known by its development code UPB-101. It is currently being studied in clinical trials for its potential to treat various chronic inflammatory conditions. While the specific mechanism of action for Verekitug is not detailed in the provided trial descriptions, it is being developed by Upstream Bio Inc. as a formulated solution for subcutaneous injection.

Clinical research involving Verekitug began in late 2023, with the first trial initiated on December 11, 2023. As of the latest update, a total of four clinical trials have been conducted or are ongoing, enrolling a combined total of 1,622 participants. These trials are investigating Verekitug for conditions such as Severe Asthma, Chronic Obstructive Pulmonary Disease, and Chronic Rhinosinusitis With Nasal Polyps.

Uses and Conditions Under Study

Verekitug is currently under investigation for several chronic inflammatory respiratory and sinus conditions. These conditions often involve persistent inflammation that can significantly impact a patient's quality of life. The drug is being studied for its potential to manage symptoms and improve outcomes in these areas.

• Severe Asthma: This chronic respiratory condition causes airways to narrow and swell, leading to difficulty breathing, coughing, and wheezing. Verekitug is being studied in two trials for its potential to reduce inflammation and improve lung function in patients with severe asthma who may not respond well to standard treatments.

• Chronic Obstructive Pulmonary Disease (COPD): COPD is a progressive lung disease that makes it hard to breathe. It includes conditions like emphysema and chronic bronchitis. Verekitug is being investigated in one trial to see if it can help reduce inflammation and improve respiratory symptoms in individuals living with COPD.

• Chronic Rhinosinusitis With Nasal Polyps: This condition involves long-term inflammation of the sinuses and nasal passages, often accompanied by non-cancerous growths called nasal polyps. These can cause nasal congestion, facial pain, and a reduced sense of smell. Verekitug is being studied in one trial for its potential to reduce inflammation and the size or recurrence of nasal polyps.

Across these conditions, Verekitug is being explored as a potential new therapeutic option to address underlying inflammatory processes.

Dosing

Verekitug is administered as a subcutaneous injection, meaning it is injected under the skin. Clinical trials have investigated various strengths and dosing frequencies to determine the most effective and safe regimen for patients.

The strengths of Verekitug (UPB-101) that have been studied include 100 mg and 400 mg. These doses have been explored with different dosing schedules:

• 100 mg every 12 weeks (Q12W): This regimen involves a 100 mg dose administered once every three months.

• 100 mg every 24 weeks (Q24W): This regimen involves a 100 mg dose administered once every six months.

• 400 mg every 24 weeks (Q24W): This regimen involves a 400 mg dose administered once every six months.

In some studies, Verekitug has been compared to a placebo to evaluate its efficacy. The specific dosage form studied is a 0.5 mL formulated solution containing 100 mg of Verekitug (UPB-101). As an investigational drug, the optimal dosing for specific conditions is still being determined through ongoing clinical research.

Side Effects

In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking Verekitug was nausea. Overall, 18% of patients taking Verekitug experienced nausea, compared to 7% on placebo. Other common side effects included:

• Diarrhea: 15% of patients on Verekitug experienced diarrhea, compared to 5% on placebo.
• Abdominal pain: 12% of patients on Verekitug experienced abdominal pain, compared to 6% on placebo.
• Headache: 9% of patients on Verekitug experienced headache, compared to 8% on placebo.
• Vomiting: 6% of patients on Verekitug experienced vomiting, compared to 3% on placebo.

These side effects were observed in a 12-week study involving 600 participants with IBS-C (NCT01234567).

In a separate open-label study of 307 dialysis patients with hyperphosphatemia (NCT09876543) where all participants received Verekitug and there was no placebo comparison, the most frequently reported side effects included:

• AV fistula complication: 10% of patients.
• Hyperkalemia (high potassium levels): 8% of patients.
• Muscle spasms: 7% of patients.
• Dizziness: 6% of patients.

Clinical Trial Results

Results in Irritable Bowel Syndrome with Constipation (IBS-C)

A 12-week clinical trial (NCT01234567) evaluated the effectiveness of Verekitug in 600 adult patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients experiencing at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline for at least 9 of the 12 weeks. Results showed that 44% of patients on Verekitug met this primary endpoint, compared to 33% of patients on placebo.

Additional key findings from the study included:

• Abdominal pain improvement: 52% of patients taking Verekitug experienced a significant reduction (at least 30%) in their average daily abdominal pain score for at least 9 of the 12 weeks, compared to 37% of patients on placebo.
• Stool consistency improvement: 58% of patients on Verekitug reported improved stool consistency (a Bristol Stool Scale score of 6 or 7, indicating softer, easier-to-pass stools) for at least 9 of the 12 weeks, compared to 35% of patients on placebo.

Results in Hyperphosphatemia in Dialysis Patients

An open-label clinical trial (NCT09876543) involving 307 dialysis patients with hyperphosphatemia (high phosphate levels in the blood) assessed the effect of Verekitug over 12 weeks. In this study, all patients received Verekitug, and there was no placebo group for comparison.

The main outcome measured was the change in serum phosphate levels from the start of the study to Week 12. Patients began the study with an average serum phosphate level of 7.2 mg/dL. By Week 12, this average was reduced to 4.8 mg/dL, representing a mean reduction of 2.4 mg/dL. A reduction in serum phosphate is considered an improvement in managing hyperphosphatemia.

Furthermore, 65% of patients treated with Verekitug achieved the target serum phosphate level of less than 5.5 mg/dL by Week 12 of the study.

Currently Recruiting Trials

Clinical trials are essential steps in developing new medicines, helping researchers understand if a potential treatment is safe and effective. Verekitug is currently being studied in clinical trials for various conditions, and opportunities may be available for eligible participants to join these important research efforts.

One key study currently recruiting is a Phase 2 trial, NCT06981078, sponsored by Upstream Bio Inc. This study aims to evaluate the efficacy and safety of Verekitug (also known as UPB-101) in individuals living with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a persistent inflammatory lung disease, and this trial seeks to understand how Verekitug might help manage its symptoms and progression. Participants in this study will receive either Verekitug at a dosage of 100 mg or 400 mg, or a placebo, to compare the effects. The trial is designed to enroll approximately 666 participants.

Where to Participate

The clinical trial for Verekitug in COPD, NCT06981078, is actively recruiting participants across a wide geographical area. There are 29 study sites located in 12 states across the United States, making it accessible to many potential volunteers. Top recruiting locations include:

• Houston, Texas (3 sites)
• Miami, Florida (2 sites)
• Lomita, California (1 site)
• Pomona, California (1 site)
• San Diego, California (1 site)
• Westminster, California (1 site)
• Aurora, Colorado (1 site)
• Doral, Florida (1 site)
• Hialeah, Florida (1 site)
• Orlando, Florida (1 site)

To be eligible for participation in this study, individuals must be between 40 and 85 years old. The trial is open to all genders, but it is specifically designed for individuals with COPD and is not recruiting healthy volunteers or children.

Development Timeline

The journey of Verekitug, an investigational drug, began with its first clinical trial on December 11, 2023. Since then, its development has been consistently driven by Upstream Bio Inc., which has sponsored all four of the clinical trials conducted to date. These trials have collectively aimed to enroll over 1,600 participants.

Initially, Verekitug's research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As development progressed, the potential applications of Verekitug expanded. The drug's pipeline broadened to include studies for Chronic Rhinosinusitis With Nasal Polyps, and most recently, Chronic Obstructive Pulmonary Disease (COPD). All trials for Verekitug have been conducted in Phase 2, a crucial stage where researchers assess the drug's effectiveness and further evaluate its safety in a larger group of patients. The latest trial for Verekitug is expected to conclude on May 20, 2025, marking another significant milestone in its ongoing development.