GB-0895 for Asthma

Overseen By Generate Recruitment

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Generate Biomedicines

Must be taking: Inhaled corticosteroids, Asthma controllers

Must not be taking: Anti-IL-5, Anti-TSLP

Disqualifiers: Respiratory disease, Cancer, Smoking, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new treatment, GB-0895, can improve the condition of people with severe asthma not well controlled by standard medications. Participants will receive either the GB-0895 treatment or a placebo (a harmless, inactive substance) every six months for one year. This trial suits individuals aged 12 and up who have had asthma for at least two years and experience frequent asthma attacks despite using inhaled corticosteroids and other asthma medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in asthma treatment.

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

Research has shown that GB-0895 has generally been well-tolerated in past studies. For instance, in studies involving individuals with mild to moderate asthma, participants accepted a single dose of GB-0895 well. This suggests it might be safe for those with more severe asthma. GB-0895 is a monoclonal antibody, targeting specific proteins related to asthma and possibly reducing inflammation for up to six months.

While detailed safety data for this trial phase isn't available, testing GB-0895 in a later phase suggests it has demonstrated a good safety profile so far. Later phases usually indicate the treatment has already passed initial safety checks in earlier trials.

For those considering joining this trial, these findings suggest that GB-0895 is promising in terms of safety, based on previous research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Researchers are excited about GB-0895 for asthma because it introduces a novel approach to managing the condition. Unlike typical asthma treatments that often rely on inhaled corticosteroids or bronchodilators to control inflammation and open airways, GB-0895 is administered as a subcutaneous injection. This unique delivery method may offer a more consistent and long-lasting effect, potentially reducing the frequency of asthma attacks and improving overall lung function. The promise of a new mechanism of action and delivery system is what has researchers hopeful about its potential impact on asthma care.

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

Research has shown that GB-0895, which participants in this trial may receive, could be a promising treatment for severe asthma. Studies have found that it works by blocking a specific protein that causes asthma inflammation. In previous studies, people with mild to moderate asthma tolerated GB-0895 well, even at different doses. The treatment also had long-lasting effects, potentially reducing asthma symptoms over time. These findings suggest that GB-0895 could benefit those with severe asthma who do not respond well to standard treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Snodgres

Principal Investigator

Generate Biomedicines

Are You a Good Fit for This Trial?

This trial is for adolescents and adults with severe asthma that isn't managed well by inhaled steroids or standard treatments. Specific details about who can join are not provided, but typically participants need to meet certain health standards.

Inclusion Criteria

I am between 12 and 80 years old.

I am over 18 and my lung function test shows less than 80% of what's expected.

I've been on a medium to high dose asthma controller for over a year and another controller for 3 months without changes.

Exclusion Criteria

Smoking history or current use of vaping products

Inability to follow study procedures, including poor adherence to medications

Pregnancy, lactation, or planned pregnancy during the study

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants undergo a run-in period to stabilize their condition before randomization

4 weeks

1 visit (in-person)

Treatment

Participants receive either GB-0895 or placebo administered subcutaneously every 6 months

52 weeks

Visits every 1-2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

38 weeks

Regular follow-up visits

Open-label extension (optional)

Participants may opt into continuation of GB-0895 treatment long-term

90 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GB-0895

Trial Overview The study is testing GB-0895 as an add-on therapy compared to a placebo. Participants will be randomly assigned to receive either the actual drug or placebo every six months for one year, with visits every 1-2 months after the first month.

How Is the Trial Designed?

Group I: GB-0895 Experimental Treatment 1 Intervention

GB-0895 Subcutaneous (SC) injection

Group II: Placebo Placebo Group 1 Intervention

Placebo Subcutaneous (SC) injection

Who Is Running the Clinical Trial?

Generate Biomedicines

Lead Sponsor

Citations

1. generatebiomedicines.com generatebiomedicines.com/media-center/generatebiomedicines-to-initiate-global-phase-3-studies-of-gb-0895-a-long-acting-anti-tslp-antibody-for-severe-asthma-engineered-with-ai

Generate:Biomedicines to Initiate Global Phase 3 Studies ... In this study of 96 people with mild to moderate asthma, GB-0895 was generally well tolerated across a wide dose range (10 mg to 1,200 mg) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07116889

A Study to Investigate GB-0895 in Adults With Mild ... The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...

3. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07276724

A Study to Investigate GB-0895 Adjunctive Therapy in ... The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe ...

5. finance.yahoo.com finance.yahoo.com/news/generate-biomedicines-initiate-global-phase-110000191.html

Generate:Biomedicines to Initiate Global Phase 3 Studies ... In this study of 96 people with mild to moderate asthma, GB-0895 was generally well tolerated across a wide dose range (10 mg to 1,200 mg), ...

6. cdn.generatebiomedicines.com cdn.generatebiomedicines.com/assets/ERS-2025-Late-Breaker-Presentation.pdf

GB-0895, a high-affinity anti-TSLP mAb, demonstrates ... – All safety data are summarized by blinded cohorts. – PK/PD data ... ▫ These data support dosing of GB-0895 subcutaneously every 6-months for severe asthma.

7. 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 ...

8. publications.ersnet.org publications.ersnet.org/highwire_display/entity_view/node/713218/full

Late Breaking Abstract - GB-0895, a high-affinity anti-TSLP ... A single dose of GB-0895 drives PD biomarker suppression for at least 6 months, reflecting the broad anti-inflammatory effects of the anti-TSLP mechanism seen ...