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GenerateBiomedicines to Initiate Global Phase 3 Studies of GB-0895

GenerateBiomedicines, a leading company specializing in programmable biology, has recently announced a significant step forward in the treatment of severe asthma. The company is set to launch two global Phase 3 clinical trials, known as SOLAIRIA-1 and SOLAIRIA-2. These trials aim to evaluate the safety and efficacy of GB-0895, a long-acting monoclonal antibody that has been engineered using artificial intelligence to specifically target thymic stromal lymphopoietin (TSLP) — a cytokine that plays a crucial role in airway inflammation.

The Purpose of the Trials

The trials will involve approximately 1,600 participants, consisting of both adults and adolescents who suffer from severe asthma that remains inadequately controlled despite existing treatment options. The primary objective is to examine whether GB-0895 can significantly reduce the frequency of asthma exacerbations over a span of 52 weeks.

GB-0895 presents several innovative features due to its AI-optimized design. This includes ultra-high-affinity binding to TSLP, extended half-life, and a targeted delivery that allows for administration every six months. This is particularly beneficial for patients who are currently burdened by more frequent dosing schedules, thereby easing the management of their condition.

Insights from the Company Leaders

Mike Nally, the CEO of GenerateBiomedicines, expressed that moving GB-0895 to Phase 3 trials is a groundbreaking achievement for the company and a reflection of the potential of programmable biology. He emphasizes that this technology enables the rapid design and optimization of molecular therapies, resulting in solutions that can be tailored for patient needs with unprecedented speed.

Dr. Laurie Lee, the Chief Medical Officer for immunology and inflammation at GenerateBiomedicines, added that despite advancements in respiratory medicine, severe asthma remains a complex challenge. The initiation of these pivotal trials underscores the company’s commitment to those who live with the condition and showcases the robust capabilities of their platform to create medicines that may alleviate chronic respiratory burdens.

Key Findings from Phase 1 Trials

Earlier data from Phase 1 trials were presented by Dr. Dave Singh at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. The Phase 1 study involved 96 individuals with mild to moderate asthma and demonstrated that GB-0895 was well-tolerated across a various dosage range (10 mg to 1,200 mg). Importantly, the studies revealed a pharmacokinetic profile that supports a potential dosing schedule of every six months, which aligns with the ongoing Phase 3 studies.

About the SOLAIRIA Trials

The SOLAIRIA trials are strategically designed to encompass more than 40 countries across North America, Europe, Latin America, and the Asia-Pacific region. Each trial will compare the effectiveness of a 300 mg subcutaneous dose of GB-0895 administered every six months against a placebo, over 52 weeks. The primary endpoint will focus on the annualized rate of asthma exacerbations, with secondary measures evaluating lung function, symptom control, and overall quality of life.

The trials are structured to ensure a diverse representation of global patient populations, thereby fostering a robust dataset that can inform future treatment guidelines and potential regulatory pathways.

Conclusion

GB-0895 was conceived using Generate’s proprietary machine-learning algorithms integrated with high-throughput experimentation, resulting in a cutting-edge therapeutic approach to asthma management. The innovation in targeting TSLP promises to reshape the treatment landscape for patients enduring severe asthma, making this a noteworthy development in respiratory medicine.

For further information about the SOLAIRIA trials and GB-0895, visit www.solairia.com or explore more resources at www.generatebiomedicines.com.