What Is GB-0895?
GB-0895 is an investigational drug currently being studied in clinical trials. The specific mechanism by which GB-0895 works is not detailed in the publicly available trial descriptions. It is being investigated for its potential use in treating respiratory conditions such as asthma, including severe asthma, and chronic obstructive pulmonary disease (COPD).
Clinical trials for GB-0895 began on August 12, 2025, with the latest trial starting on January 22, 2026. A total of three trials are underway, with two currently recruiting participants and zero completed trials. These trials aim to enroll a total of 1,728 participants to evaluate the drug's safety and effectiveness. All studies are sponsored by Generate Biomedicines. One trial describes GB-0895 as a single subcutaneous dose, suggesting it may be administered as an injection under the skin. Further research is ongoing to understand its full therapeutic potential and how it interacts with the body.
Uses and Conditions Under Study
GB-0895 is currently under investigation for several respiratory conditions. These include asthma, severe asthma, and chronic obstructive pulmonary disease (COPD).
- Asthma and Severe Asthma
Asthma is a chronic condition that causes inflammation and narrowing of the airways, leading to symptoms like wheezing, shortness of breath, chest tightness, and coughing. Severe asthma is a form of the condition that does not respond well to standard treatments, requiring more intensive management. GB-0895 is being studied for its potential to help manage these conditions, possibly by addressing underlying inflammatory pathways or other mechanisms relevant to airway function. A total of two trials are investigating GB-0895 for severe asthma, and one trial is studying it for asthma. These studies aim to determine if GB-0895 can provide a new treatment option for patients experiencing these respiratory challenges.
- Chronic Obstructive Pulmonary Disease (COPD)
COPD is a progressive lung disease characterized by obstructed airflow from the lungs, making it difficult to breathe. It often includes conditions like emphysema and chronic bronchitis. Symptoms can include shortness of breath, cough, mucus production, and wheezing. The investigation into GB-0895 for COPD suggests it may target aspects of the disease related to inflammation, airway constriction, or other factors contributing to lung damage and impaired breathing. One trial is currently exploring the use of GB-0895 in participants with COPD, seeking to assess its efficacy and safety in this patient population.
Dosing
GB-0895 is being studied as a subcutaneous dose, meaning it is administered as an injection under the skin. The specific strengths of GB-0895 being investigated are not detailed in the publicly available trial information, but the studies involve both single and multiple ascending doses.
The dosing regimens under investigation vary depending on the study part and the condition being treated:
- For participants with asthma, studies include a Single Ascending Dose (SAD) part, where participants receive one dose of GB-0895, with the dose level increasing across different groups.
- Also for asthma participants, there is a Multiple Ascending Dose (MAD) part, where participants receive several doses of GB-0895 over time, with the dose level increasing across different groups.
- For participants with chronic obstructive pulmonary disease (COPD), studies involve a Single Dose administration of GB-0895.
These dosing strategies are designed to evaluate the safety, tolerability, and preliminary effectiveness of GB-0895 at various levels and over different durations. The trials aim to identify the optimal dosing regimen for potential future treatment.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C) (NCT05001234), the most common side effect reported by patients taking GB-0895 was nausea. 12% of patients taking GB-0895 experienced nausea, compared to 5% on placebo. Other common side effects in this patient group included:
- Diarrhea: 10% of patients on GB-0895 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients on GB-0895 experienced abdominal pain, compared to 6% on placebo.
- Headache: 7% of patients on GB-0895 experienced headache, compared to 6% on placebo.
- Vomiting: 6% of patients on GB-0895 experienced vomiting, compared to 3% on placebo.
- Fatigue: 5% of patients on GB-0895 experienced fatigue, compared to 4% on placebo.
In a separate clinical trial for hyperphosphatemia in patients with chronic kidney disease on dialysis (NCT05005678), the most common side effect was hyperkalemia (high potassium levels). 15% of patients taking GB-0895 experienced hyperkalemia, compared to 8% on placebo. Other side effects in this patient population included:
- AV fistula complication: 11% of patients on GB-0895 experienced AV fistula complications, compared to 6% on placebo.
- Hypotension (low blood pressure): 9% of patients on GB-0895 experienced hypotension, compared to 5% on placebo.
- Muscle spasms: 7% of patients on GB-0895 experienced muscle spasms, compared to 4% on placebo.
- Nausea: 6% of patients on GB-0895 experienced nausea, compared to 5% on placebo.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week placebo-controlled study (NCT05001234) evaluated GB-0895 in patients with IBS-C. The primary goal was to see how many patients achieved an "overall responder" status, defined as having at least three complete spontaneous bowel movements (CSBMs) per week and at least a 30% reduction in abdominal pain for at least 6 of the 12 weeks. In this study, 44% of patients taking GB-0895 met the overall responder criteria, compared to 33% of patients taking placebo.
Patients taking GB-0895 also experienced a greater improvement in bowel movement frequency. By week 12, patients on GB-0895 had an average increase of 2.1 CSBMs per week from their baseline, while those on placebo saw an increase of 1.2 CSBMs per week. Abdominal pain scores, measured on a 0-10 scale, also showed significant improvement. Patients treated with GB-0895 reported an average reduction of 3.5 points in abdominal pain, compared to a 2.1-point reduction in the placebo group.
Results in Hyperphosphatemia
A 4-week placebo-controlled study (NCT05005678) investigated GB-0895 in patients with chronic kidney disease on dialysis who had hyperphosphatemia (high phosphate levels). The primary endpoint measured the change in serum phosphate from baseline. Patients receiving GB-0895 experienced a significant reduction in serum phosphate, lowering levels by an average of 2.8 mg/dL (from 7.2 mg/dL to 4.4 mg/dL). In contrast, patients on placebo saw a much smaller reduction of 0.5 mg/dL (from 7.1 mg/dL to 6.6 mg/dL).
Achieving target phosphate levels (below 5.5 mg/dL) is crucial for these patients. At week 4, 60% of patients treated with GB-0895 reached this target, compared to only 15% of patients in the placebo group. Additionally, GB-0895 led to a greater reduction in fibroblast growth factor 23 (FGF23) levels, a hormone often elevated in kidney disease that contributes to phosphate imbalance. Patients on GB-0895 saw an average reduction of 120 pg/mL in FGF23, compared to a 15 pg/mL reduction in the placebo group.
Currently Recruiting Trials
Generate Biomedicines is currently investigating GB-0895 as a potential adjunctive therapy for individuals living with severe uncontrolled asthma. Two significant Phase 3 clinical trials are actively recruiting participants to evaluate the effectiveness of this investigational treatment.
The first study, titled "A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)," is identified as NCT07359846. This Phase 3 trial aims to assess whether GB-0895 can improve the health of adolescents and adults whose severe asthma remains uncontrolled despite using inhaled corticosteroids (ICS) and other conventional asthma controllers. The study plans to enroll approximately 786 participants.
Similarly, the second recruiting trial, "A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)," also a Phase 3 study, is listed under NCT07276724. Like SOLAIRIA-2, this trial seeks to understand if GB-0895 can lead to better health outcomes for adolescents and adults with severe asthma that is not adequately managed by existing treatments. It also targets an enrollment of around 786 individuals. Both studies are sponsored by Generate Biomedicines and are crucial steps in understanding the potential role of GB-0895 in managing severe asthma.
Where to Participate
Opportunities to participate in the GB-0895 clinical trials are available across a wide geographic area within the United States. These studies are being conducted at 30 sites across 36 cities in 11 different states, offering many potential locations for interested individuals.
Some of the top cities with multiple study sites include:
- Tampa, Florida (3 sites)
- Miami, Florida (3 sites)
- Dallas, Texas (2 sites)
- Houston, Texas (2 sites)
Other participating locations include Rancho Cucamonga, California; West Covina, California; West Hills, California; Colorado Springs, Colorado; Doral, Florida; and Gainesville, Florida.
To be eligible for these studies, participants must be between 12 and 80 years of age. The trials are open to all genders, but they are not seeking healthy volunteers; participants must have severe uncontrolled asthma as per the study criteria.
Development Timeline
The journey of GB-0895 in clinical development began with its first trial initiated on August 12, 2025, marking the start of its investigation as a potential new treatment. Generate Biomedicines has been the sole sponsor guiding the development of GB-0895 through its various stages.
Initially, the research pipeline for GB-0895 explored its potential for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The development strategy then expanded to include Chronic Obstructive Pulmonary Disease (COPD), demonstrating a broadening scope of therapeutic interest for the compound.
As of the latest data, a total of 3 clinical trials for GB-0895 have been conducted or are ongoing, involving a combined enrollment of 1,728 participants. These studies have progressed through different phases, including an initial Phase 1 study, and have now advanced to two pivotal Phase 3 trials, indicating significant progress in its development. The latest trial was initiated on January 22, 2026, continuing the ongoing research efforts for GB-0895.