Vial, a clinical-stage biotechnology company, has successfully dosed the first healthy volunteers in its Phase 1 trial of VIAL-TL1A-HLE, a novel subcutaneous monoclonal antibody targeting TL1A for the treatment of moderate-to-severe inflammatory bowel disease (IBD) and other inflammatory and fibrotic conditions.
The San Francisco-based company announced the dosing milestone on June 25, 2025, marking a critical advancement in its development of what it describes as a potentially best-in-class treatment for IBD patients.
Phase 1 Trial Design and Objectives
The Phase 1 trial is a first-in-human, single-ascending dose study in healthy volunteers designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous VIAL-TL1A-HLE administration. The company expects to report interim safety and pharmacokinetic data from healthy volunteers in the second half of 2025.
"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."
Proprietary Half-Life Extension Technology
VIAL-TL1A-HLE incorporates Vial's proprietary half-life extension technology, targeting TL1A—a clinically validated driver of inflammation in ulcerative colitis and Crohn's disease. The antibody demonstrated strong inhibition of TL1A-mediated apoptosis of TF-1 cells in laboratory studies.
According to Preeti Sareen, Ph.D., Head of Strategy, preclinical data indicate the antibody has potential for best-in-class half-life with improved durability over first and second-generation anti-TL1A antibodies. "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," Sareen stated.
The enhanced half-life profile could translate to improved dosing intervals, offering greater convenience for patients managing chronic inflammatory conditions compared to existing anti-TL1A candidates.
Clinical Development Timeline
Following the Phase 1 interim data readout expected in the second half of 2025, Vial plans to initiate a multi-region Phase 2 trial in IBD later in 2025. The company's accelerated development timeline reflects confidence in the therapeutic approach and the potential clinical impact.
"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," said Simon Burns, Chief Executive Officer. "We are confident that this novel therapy is poised to redefine patient care and profoundly improve patient lives."
TL1A as a Therapeutic Target
TL1A inhibition represents a promising therapeutic approach with the potential to target both inflammation and fibrosis, with clinical data supporting compelling efficacy in IBD, according to the company. The target's dual mechanism addressing both inflammatory and fibrotic components of IBD could offer advantages over existing therapies.
Company Background
Founded in 2020, Vial has raised over $100 million from leading life sciences investors including General Catalyst, Buckley Ventures, and Byers Capital. The company employs over 60 people across research and development, clinical development, clinical operations, engineering, product, and design functions, focusing on advancing a pipeline of potentially best-in-class biologics and RNA therapeutics across areas of unmet medical need.
