In short
ATH-063 hydrochloride is an investigational substance being studied for the treatment of moderately to severely active ulcerative colitis. A Phase 2 clinical trial is currently authorised to evaluate its efficacy and safety in 120 patients with relapsed or refractory disease. The trial compares ATH-063 capsules with a placebo over 12 weeks, measuring clinical remission as the primary outcome.
Key points
- ATH-063 hydrochloride is an investigational oral substance studied in ulcerative colitis.
- The authorised trial is a Phase 2 proof-of-concept study.
- It is double-blind and placebo-controlled, comparing ATH-063 with matching placebo capsules.
- 120 participants with relapsed or refractory moderately to severely active ulcerative colitis are planned.
- The primary outcome is clinical remission measured at Week 12.
- ATH-063 is given as 150 mg capsules taken orally.
What is ATH-063 hydrochloride?
ATH-063 hydrochloride is an investigational substance under development for the treatment of ulcerative colitis, a chronic inflammatory bowel disease affecting the large intestine. The substance is currently being evaluated in a Phase 2 proof-of-concept clinical trial; it does not have a marketing authorisation in the data provided. The hydrochloride salt form indicates that the active substance is prepared as a salt to improve its properties for oral administration.
How does ATH-063 hydrochloride work?
The mechanism of action of ATH-063 hydrochloride is not described in the available registry data. The trial record focuses on evaluating clinical efficacy and safety in patients with ulcerative colitis, but does not state the molecular target or biological pathway affected by the substance.
Which conditions is ATH-063 hydrochloride studied for?
- Active ulcerative colitis — a chronic condition causing inflammation and ulcers in the lining of the large intestine, leading to symptoms such as abdominal pain and bloody diarrhoea. The trial specifically includes patients with moderately to severely active disease that has relapsed or not responded to previous treatment.
How is ATH-063 hydrochloride given?
In the authorised trial, ATH-063 is given as capsules containing 150 mg of the substance, taken orally. The placebo arm consists of matching capsules containing microcrystalline cellulose, dispensed in the same way. Three capsules are dispensed monthly at Day 1, Week 4, and Week 8 in 30-count bottles.
What do the clinical trials show?
One clinical trial is listed for ATH-063 hydrochloride: a double-blind, placebo-controlled Phase 2 proof-of-concept study evaluating efficacy and safety in patients with relapsed or refractory moderately to severely active ulcerative colitis. The trial plans to enrol 120 participants and is currently authorised, meaning it has received regulatory approval to begin but may not yet be recruiting.
The primary outcome is clinical remission, measured at Week 12 using the Ulcerative Colitis Disease Severity Score (UCDSS). Clinical remission means that the signs and symptoms of ulcerative colitis have largely or completely disappeared. The study compares ATH-063 150 mg capsules taken orally with a matching placebo.
What side effects are known?
No side effect data for ATH-063 hydrochloride is available in the provided sources. The authorised trial is designed to evaluate safety, but results have not been reported in the registry record.