GB-0895 for Asthma and COPD

Not currently recruiting at 12 trial locations

Overseen By Generate Recruitment

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Generate Biomedicines

Disqualifiers: Other serious disease, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new treatment called GB-0895 for individuals with asthma or COPD, a lung disease that makes breathing difficult. The trial aims to assess how well the body tolerates this treatment and its behavior inside the body. The study consists of different parts: one for individuals with asthma testing single and multiple doses, and another for those with COPD testing a single dose. It suits individuals with mild to moderate asthma for over a year or COPD for over a year, who are current or former smokers. Participants should not have experienced recent serious flare-ups or require oxygen for COPD. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GB-0895 is likely to be safe for humans?

Research has shown that GB-0895, a protein designed to target and neutralize specific substances in the body, has been well-tolerated by patients with mild to moderate asthma. In studies, patients who received a single dose of this treatment reported only minor side effects. Although this trial is in its early stages, past experiences suggest that GB-0895 might be safe for humans.

Since this trial is in the first phase, it primarily focuses on safety and tolerability. Researchers are examining how the body responds to the treatment and identifying any side effects. These early trials are crucial to determine if a treatment is safe enough for larger studies. While there is no guarantee, existing data from past studies is promising for GB-0895. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for asthma and COPD, which often include inhaled corticosteroids or bronchodilators, GB-0895 is unique because it targets inflammation through a novel pathway. Researchers are excited about GB-0895 because it may offer more specific control over inflammatory responses, potentially reducing side effects associated with current therapies. Additionally, its design allows for both single and multiple dosing, which could enhance its flexibility and effectiveness in treating different stages of these conditions. This innovative approach could lead to quicker relief and improved quality of life for patients suffering from asthma and COPD.

What evidence suggests that GB-0895 might be an effective treatment for asthma and COPD?

Research has shown that GB-0895 could be a promising treatment for asthma and COPD (chronic obstructive pulmonary disease). This monoclonal antibody targets a protein involved in lung inflammation, helping to reduce inflammation in the lungs. The trial includes different treatment arms: Part A involves a Single Ascending Dose (SAD) for asthma participants, Part B involves a Multiple Ascending Dose (MAD) for asthma participants, and Part C involves a Single Dose for COPD participants. Early findings suggest that GB-0895 remains active in the body longer, potentially reducing the number of doses needed. Initial studies have indicated it might be effective for people with severe asthma, especially those with difficult-to-treat symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 18-65 with mild to moderate asthma diagnosed for at least a year can join this trial. They must have specific blood values, be able to consent in writing, and not require supplemental oxygen (except CPAP for sleep apnea). Smokers or those with a significant smoking history, pregnant or breastfeeding individuals, and people with recent COPD exacerbations or other serious diseases cannot participate.

Inclusion Criteria

Laboratory blood values within the ranges outlined in the protocol

Participants must be able to give written consent

I am between 18 and 65 years old.

Exclusion Criteria

Requires supplemental oxygen (CPAP for sleep apnea allowed)

I am between 40 and 80 years old.

Must be current or ex-smoker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants with asthma receive a single ascending dose of GB-0895 or placebo

1 week

Multiple Ascending Dose (MAD)

Participants with asthma receive multiple ascending doses of GB-0895 or placebo

4 weeks

Single Dose

Participants with COPD receive a single dose of GB-0895 or placebo

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GB-0895

Trial Overview The study is examining GB-0895's safety and how the body reacts to it compared to a placebo. Both are given by subcutaneous injection. Researchers will look at how the drug is absorbed, distributed, metabolized, and excreted from the body as well as its effects on lung function.

How Is the Trial Designed?

Group I: Part C: Single Dose (COPD participants) Experimental Treatment 2 Interventions

randomized 3:1 active:placebo

Group II: Part B: Multiple Ascending Dose (MAD) (asthma participants) Experimental Treatment 2 Interventions

randomized 3:1 active:placebo

Group III: Part A: Single Ascending Dose (SAD) (asthma participants) Experimental Treatment 2 Interventions

randomized 3:1 active:placebo

Who Is Running the Clinical Trial?

Generate Biomedicines

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07116889

NCT07116889 | A Study to Investigate GB-0895 in Adults ... See Delay Results Type in the Results Data Element definitions for more ... A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD.

2. generatebiomedicines.com generatebiomedicines.com/media-center/generatebiomedicines-to-present-phase-1-results

Generate:Biomedicines to Present Phase 1… GB-0895, a next-generation, ultra-high affinity anti-TSLP monoclonal antibody, demonstrated prolonged half-life and sustained pharmacology ...

3. publications.ersnet.org publications.ersnet.org/content/erj/64/suppl68/pa2983

A long-acting high affinity anti-TSLP antibody (GB-0895) for ... Conclusions: GB-0895 has the potential for best-in-class dosing for patients with severe asthma. A phase 1 dose escalation trial in asthma patients is underway.

4. prnewswire.com prnewswire.com/news-releases/generatebiomedicines-to-present-phase-1-results-for-ai-engineered-gb-0895-in-asthma-at-the-european-respiratory-society-international-congress-302566586.html

Generate:Biomedicines to Present Phase 1 Results for AI- ... "GB-0895 could provide an important treatment alternative for patients with respiratory diseases, including severe asthma, building on the ...

5. trialx.com trialx.com/clinical-trials/listings/301171/a-study-to-investigate-gb-0895-in-adults-with-mild-to-moderate-asthma-or-copd/

A Study to Investigate GB-0895 in Adults With Mild ... Clinical trial for COPD (Chronic Obstructive Pulmonary Disease) | Asthma , A Study to Investigate GB-0895 in Adults With Mild to Moderate ...

6. healio.com healio.com/news/allergy-asthma/20251014/monoclonal-antibody-effects-persist-for-6-months-in-patients

Monoclonal antibody effects persist for 6 months in patients GB-0895 was also well tolerated. Patients with mild to moderate asthma receiving one dose of an anti-thymic stromal lymphopoietin monoclonal ...

7. channel.ersnet.org channel.ersnet.org/media-113432-a-long-acting-high-affinity-anti-tslp-antibody-gb-0895-for-severe-asthma-identified-leveraging-a-proprietary-machine-learning-platform

A long-acting high affinity anti-TSLP antibody (GB-0895) for ... A long-acting high affinity anti-TSLP antibody (GB-0895) for severe asthma identified leveraging a proprietary machine learning platform.

8. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-gb-0895-in-adults-with-mild-to-moderate-asthma-or-copd

A Study to Investigate GB-0895 in Adults With Mild to ... This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.

9. linkedin.com linkedin.com/posts/alexandra-snyder-charen_im-proud-to-share-that-gb-0895-our-anti-tslp-activity-7316431635493646336-NTbY

GB-0895 anti-TSLP antibody starts COPD trial GB-0895, our anti-TSLP monoclonal antibody, has entered a Phase 1 clinical trial in adults with chronic obstructive pulmonary disease (COPD).