Vial Initiates Phase 1 Trial of Subcutaneous Half-Life Extended Anti-TL1A Antibody for IBD

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-25

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Vial, a clinical-stage biotechnology company, announced the first-in-human dosing of its novel, subcutaneous, half-life extended monoclonal antibody targeting TL1A. This antibody is being developed as a potentially best-in-class treatment for moderate-to-severe inflammatory bowel disease (IBD), as well as other inflammatory and fibrotic diseases. The Phase 1 trial will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers. Interim data is expected in the second half of 2025, with plans to initiate a Phase 2 trial in IBD later in the year. The drug demonstrated strong inhibition of TL1A-mediated apoptosis in preclinical studies, suggesting a best-in-class dosing interval.

Key Highlights

  • First-in-human dosing of Vial's half-life extended anti-TL1A antibody completed.
  • Phase 1 trial evaluating safety, tolerability, and pharmacokinetics in healthy volunteers.
  • Interim data expected in H2 2025, with plans for a Phase 2 trial in IBD.
  • Preclinical data suggests best-in-class dosing interval for patient convenience and efficacy.

Incidence and Prevalence

Global Incidence and Prevalence of Inflammatory Bowel Disease

Global Overview

Inflammatory bowel diseases (IBD), including both Crohn's disease (CD) and ulcerative colitis (UC), are disorders of chronic inflammation of the gastrointestinal tract marked by episodes of relapse and remission. The number of persons affected by IBD worldwide has increased from 3.7 million in 1990 to 6.8 million in 2017, demonstrating a significant global burden of these conditions.

Regional Epidemiology

Western Countries

In the West, the incidence and prevalence of inflammatory bowel diseases has increased in the past 50 years: - Ulcerative colitis (UC): Incidence of 8-14/100,000 and prevalence of 120-200/100,000 persons - Crohn's disease (CD): Incidence of 6-15/100,000 and prevalence of 50-200/100,000 persons

United States

Among U.S. Medicare beneficiaries aged ≥67 years in 2018: - 0.40% had Crohn's disease - 0.64% had ulcerative colitis

During 2001-2018 in the U.S., the age-adjusted prevalence of both diseases increased: - Crohn's disease annual percentage change (APC) = 3.4% - Ulcerative colitis APC = 2.8%

The increase in prevalence was higher among non-Hispanic Black persons (Crohn's disease APC = 5.0%, ulcerative colitis APC = 3.5%) than among non-Hispanic White, Hispanic, and Asian/Pacific Islander persons. Prevalence was consistently highest among non-Hispanic White persons for both diseases and lowest among Asian/Pacific Islander persons for Crohn's disease.

Kingdom of Saudi Arabia (KSA)

A study of 693 Saudi patients with IBD over 17 years (1993-2009) showed: - 238 (34.3%) ulcerative colitis patients - 455 (65.7%) Crohn's disease patients - UC remained steady throughout the years - CD increased significantly from 1.2 patients diagnosed per year in the first 11 years to 73.7 per year in the last six years

IBD is no longer a rare disease in KSA, with UC in a steady state, whereas CD is increasing significantly and far outnumbering UC.

Mexico

In Mexico, a study at a referral hospital in North-Eastern Mexico showed: - The adjusted rate of patients diagnosed with UC increased from 2.3 to 4.1 per 1000 admissions between 2004 and 2008 - The rate of newly diagnosed patients with UC doubled in 2008 compared with 2004

Korea

In Korea, the estimated IBD prevalence significantly increased from 108.8 per 100,000 in 2008 to 140.4 per 100,000 in 2017.

Temporal Trends

  • IBD was rare before the 1930's but the incidence has been increasing in both developed and developing countries
  • Studies of migrant populations and populations of developing countries demonstrated a recent, slow increase in the incidence of UC, whereas that of CD remained low, but CD incidence eventually increased to the level of UC
  • The morbidity of IBD has increased steadily over the past half century worldwide
  • In Nova Scotia, which has one of the highest reported burden globally, the incidence has been decreasing since 1997
  • The incidence of pediatric IBD has risen alarmingly in the Western and developing world in recent decades

Associated Factors

Improved health care, diet changes, and higher industrialization are associated with an increase in IBD prevalence.

Disease Characteristics

  • CD and UC are incurable; they begin in young adulthood and continue throughout life
  • The mortality of patients with UC is not greater than that of the general population, but patients with CD have greater mortality than the population

Drug used in other indications

Half-life Extended Anti-TL1A Antibody Clinical Trials

Based on the available information, there is no specific data regarding half-life extended anti-TL1A antibody being trialed for inflammatory bowel disease or any other indications. The context does not provide any information about:

  • Clinical trials for anti-TL1A antibodies
  • Indications beyond inflammatory bowel disease
  • Intervention models or study designs for such trials
  • Any protocols related to half-life extended anti-TL1A antibody treatments

Without specific information available in the provided context, it is not possible to detail the clinical indications being investigated or the study designs and intervention protocols being utilized in trials of half-life extended anti-TL1A antibodies.

Company drugs in pipeline

Vial's Pharmaceutical Pipeline Indications

Based on the provided context, there is no specific information available about Vial Pharmaceuticals' drug pipeline, therapeutic areas, disease states, medical conditions, investigational compounds, or drug candidates in clinical development.

The context does not contain any details about: - Current pipeline assets - Targeted disease indications - Clinical trial stages - Therapeutic focus areas - Preclinical or clinical stage compounds

Without this information in the provided context, I cannot provide details about which indications Vial has drugs in pipeline for.