Vial Announces Dosing of First Patient in Phase 1 Healthy Volunteer Trial
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INHBE (Activin E)

VIAL-INHBE is designed to block Activin E signaling and increase lipolysis for fat-selective weight loss, which could maintain high quality weight loss during and post-GLP-1 cessation.
  • Pre-clinical studies demonstrate fat-selective weight loss and off-treatment weight maintenance.
  • Additional key IND-enabling study readouts in Q4 2025.
  • Phase 1 FPI in Q1 2026.
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Key Data

Based on in vitro and in vivo studies, VIAL-INHBE effectively demonstrates functional potency and target-binding comparable to or better than clinical programs.

Graph showing peripheral venous blood-plasma-concentration dosing simulation
In DIO mice
  • VIAL-INHBE treatment leads to fat-selective weight loss and weight loss is maintained post-treatment cessation.
  • VIAL-INHBE supports fat loss maintenance post-GLP-1 treatment cessation.
  • VIAL-INHBE is synergistic with GLP-1 treatment to support added fat loss and weight loss.
Lead series data
  • Lead series shows high stability in NHP liver lysates (S9 fractions) during the 72 hr incubation, indicating potential for a favorable dosing interval.
  • Lead series displays robust knockdown potency in primary human hepatocytes, indicating potential for strong efficacy.
  • Lead series displays low risk of immunogenicity in human PBMCs, indicating potential for a strong safety profile.

Differentiated Product Profile​

VIAL-TL1A-HLE is potentially a best-in-class anti-TL1A mAb with an extended half-life to support Q9-12M dosing, powered by Vial’s HLE platform. The program is also applicable to MASH, Atopic Dermatitis, SSc-ILD, Rheumatoid Arthritis, Hidradenitis Suppurativa, among others.

Updates

So 1st of all, TL1A Is one of the hot targets at the moment for both Crohn's and Uc. And one of the major challenges that we have in the clinic is to have drugs that need frequent administration and patients like to have drugs that are very effective and that are super safe, and that are easy to administer.

So instead of every 2 weeks, every month, having an injection every 6 months, or once a year, with a very safe mechanism of action. I mean, this is the ideal thing to have for a patient perspective and also for a doctor.

Dr. Silvio Danese
Gastroenterologist, San Raffaele Scientific Institute

A long half-life reduces the burden on the patient hopefully provides a very steady state concentration of drug and binding of the target over the extended half-life, which in theory should be very good at preventing episodic flares.

Dr. Peter Higgins
Gastroenterologist, San Raffaele Scientific Institute

I mean, IBD is a lifelong condition that requires long-term management. Many patients struggle with treatment, fatigue, adherence, challenges, and disruptions in daily life. So an extended half-life TL1A therapeutic, especially one with the potential for once yearly dosing, could significantly improve the quality of life, of reducing injection burden, minimizing clinic visits and maintaining consistent disease control.

Dr. Viral Patel
Gastroenterologist
Press Release
Vial Announces Dosing of First Participants in Phase 1 Healthy Volunteer Trial of a Novel Subcutaneous Half-Life Extended Anti-TL1A Antibody for the Treatment of IBD and Other Inflammatory and Fibrotic Diseases
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