ATH-063 for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, ATH-063, for individuals with ulcerative colitis (UC) who have not responded well to other advanced treatments. Participants will receive either ATH-063 or a placebo (a pill with no active medicine) to determine if ATH-063 can improve their symptoms. This trial may suit those who have had UC for at least four months, experience ongoing symptoms despite other treatments, and have UC affecting more than 15 cm of their colon. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that ATH-063 is likely to be safe for humans?
Research has shown that ATH-063 appears safe for humans. In a recent study, participants tolerated ATH-063 well, with no deaths or serious side effects reported. No one discontinued treatment due to side effects, indicating that this treatment might be safe for people with ulcerative colitis, even if other advanced treatments have failed.
Earlier trials tested ATH-063, administering it once daily. These trials found that participants generally tolerated the treatment well. The absence of serious side effects in these studies suggests that ATH-063 is likely safe.
As testing continues, researchers are gathering more information to confirm these findings.12345Why do researchers think this study treatment might be promising for ulcerative colitis?
ATH-063 is unique because it targets ulcerative colitis with a potentially new mechanism of action. While most treatments, like aminosalicylates, corticosteroids, and immunosuppressants, focus on reducing inflammation or modulating the immune system, ATH-063 might offer a novel way to manage the disease. Researchers are excited about ATH-063 because it could provide an alternative for patients who don't respond well to existing therapies, potentially offering better symptom control with a convenient oral dosing schedule. This could make managing ulcerative colitis easier and more effective for many patients.
What evidence suggests that ATH-063 might be an effective treatment for ulcerative colitis?
Research has shown that ATH-063 shows early promise as a treatment for ulcerative colitis (UC). This trial will evaluate ATH-063, which reduces inflammation and heals the gut lining, crucial for people with UC. Early data from a recent conference indicated that the body absorbs and processes ATH-063 well. Additionally, earlier studies found that ATH-063 was generally well-tolerated and may increase certain cells that help control the immune system. This could benefit those whose UC hasn't improved with other advanced treatments.12346
Who Is on the Research Team?
David T. Rubin, MD
Principal Investigator
University of Chicago Biological Sciences Division
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with moderately to severely active ulcerative colitis that has not responded well to at least one prior biologic treatment (including anti-TNF therapy) and standard medications. Participants must not be pregnant or breastfeeding, and must use effective birth control if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ATH-063 or placebo orally once daily for 12 weeks
Open-label extension
Participants who received placebo may opt into receiving open-label ATH-063 from Week 12 to Week 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ATH-063
Trial Overview
The study compares a new drug called ATH-063 against a placebo in people with hard-to-treat ulcerative colitis. Participants are randomly assigned to receive either the new medication or an inactive pill, and neither they nor their doctors know which one they're getting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive ATH-063 150 mg orally QD for 12 weeks, with posttreatment follow-up at Weeks 16 and 24.
Participants will be randomized to receive matching placebo orally QD for 12 weeks, with posttreatment follow-up at Weeks 16 and 24.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Athos Therapeutics Inc
Lead Sponsor
Citations
NCT07513181 | Proof of Concept Study Evaluating the ...
The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory ...
Athos Therapeutics Highlights Potential of AI-Generated ...
ATH-063 offers potential advantages as an oral therapy with a differentiated profile, addressing unmet needs in refractory patients and ...
Potential of an AI-Generated First-in-Class Agent for IBD
ATH-063 is the first drug that we developed. Our approach is to use artificial intelligence and start with patient samples and patient data. We ...
First-In-Class AI-Generated ATH-063 Shows Potential
According to data presented at the 2026 Crohn's and Colitis Congress, ATH-063 showed preliminary potential with a favorable pharmacokinetics ...
Athos Therapeutics Receives US FDA Authorization to ...
ATH-063 is a novel, oral, first-in-class, small molecule therapeutic targeting both inflammation and direct mucosal healing in patients with ...
Study Details | NCT05807971 | Assessment of Safety, ...
Primary Objective of this study will be to evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses ...
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