- First-in-human dosing has successfully commenced with healthy volunteers
- Primary endpoints for this Phase 1 include safety, tolerability, and pharmacokinetic profile after subcutaneous administration
- Interim subcutaneous safety and pharmacokinetic data from healthy volunteers are expected in H2 2025
- Vial’s half-life extended anti-TL1A is a novel, subcutaneous mAb with proprietary half-life extension technology targeting TL1A as a potentially best-in-class treatment for IBD
June 25, 2025 – Vial, a clinical-stage biotechnology company, announced that it has successfully dosed healthy volunteers in its first clinical trial for a novel, subcutaneous, half-life extended monoclonal antibody targeting TL1A, which is being developed as a potentially best-in-class treatment for people living with moderate-to-severe IBD, as well as other I&I and fibrotic diseases.
“Advancing a therapy like Vial’s half-life extended anti-TL1A into human clinical studies represents a critical juncture in our translational research efforts,” said Josh Pascoe, Chief Operations Officer. “For individuals living with the daily challenges of chronic inflammatory conditions such as IBD, the potential for a treatment offering robust therapeutic benefit alongside a substantially improved dosing regimen could truly redefine patient management.”
The Phase 1 trial is a first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a subcutaneous dose of Vial’s half-life extended anti-TL1A. Vial expects interim data from the trial in the second half of 2025 and plans to initiate a multi-region Phase 2 trial in IBD later in 2025.
Simon Burns, Chief Executive Officer at Vial, commented on the milestone: “The advancement of Vial’s half-life extended anti-TL1A into clinical development represents an inflection point, validating our innovative approach, strategic vision, and the proven effectiveness of our drug development model. We are confident that this novel therapy is poised to redefine patient care and profoundly improve patient lives.”
Vial’s HLE anti-TL1A
Vial’s HLE anti-TL1A is a novel subcutaneous mAb with proprietary half-life extension targeting TL1A—a clinically validated driver of inflammation in ulcerative colitis and Crohn’s Disease. Vial’s half-life extended anti-TL1A demonstrated strong inhibition of TL1A mediated apoptosis of TF-1 cells, and preclinical data indicate a best-in-class dosing interval for patient convenience and efficacy compared to the first and second generation anti-TL1A candidates.
About Vial
Vial is a clinical-stage biotech company based in San Francisco that has raised $100M+ to date from leading life sciences investors including General Catalyst, Buckley Ventures, and Byers Capital. Vial is focused on advancing a pipeline of potentially best-in-class biologics and RNA therapeutics across areas of unmet medical need. Founded in 2020, Vial has over 60 employees across R&D, Clinical Development, Clinical Operations, Engineering, Product, and Design.
Contact:
Max James, Chief Business Officer
max.james@vial.com
For Media:
press@vial.com
