- VIAL-TL1A-HLE is a novel, subcutaneous mAb with **proprietary half-life extension technology** targeting TL1A for a potentially best-in-class treatment for IBD
- Preclinical data support the potential for **best-in-class dosing interval** for patient convenience and efficacy ****among anti-TL1A therapies
- A Phase 1 open-label study in Australia is underway to evaluate safety, pharmacokinetics, and pharmacodynamic responses in healthy volunteers
- Interim subcutaneous safety and pharmacokinetic data from healthy volunteers expected in H2 2025
Vial, a clinical-stage biotechnology company, announced that it has initiated dosing of healthy volunteers in its first clinical trial for a novel subcutaneous, extended half-life 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.
“The initiation of the Phase 1 healthy volunteer trial for Vial’s half-life extended TL1A program is a milestone on our journey of advancing next-generation biologics programs. We look forward to engaging the IBD community with the interim data from the VIAL-TL1A-HLE Phase 1”
Simon Burns, CEO of Vial
The VIAL-TL1A-HLE 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-TL1A-HLE. 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.
“TL1A inhibition has the potential to target both inflammation and fibrosis with clinical data supporting compelling efficacy in IBD. By leveraging our proprietary half-life extension technology, VIAL-TL1A-HLE has the potential to deliver much-needed convenience to patients suffering from this chronic disease. We have shown in preclinical studies that VIAL-TL1A-HLE has the potential for best-in-class half-life with improved durability over first and second-generation anti-TL1A antibodies”
Preeti Sareen, Ph.D., Director of Strategy
About VIAL-TL1A-HLE
VIAL-TL1A-HLE 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-TL1A-HLE 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, and is hiring.
Contact:
Max James, Chief Business Officer
max.james@vial.com
For Media:
press@vial.com
