ESK-001 clinical programs
In psoriasis, there is a significant need to have a safe and highly effective oral therapy. ESK-001 has the potential to offer an oral therapy with superior efficacy compared to other available or investigational treatments for plaque psoriasis.
Psoriasis is an autoimmune skin condition that causes itchiness and discomfort. It is a common, chronic disease with no cure. Plaque psoriasis, the most common type of psoriasis, causes dry, itchy, raised skin patches (plaques) covered with scales. Disease severity can vary depending on intensity of symptoms. Moderate to severe disease has a greater negative impact on quality of life, with nearly one-quarter of psoriasis patients considered to have moderate to severe disease.
About the STRIDE Clinical Trial
The STRIDE clinical trial is a randomized, double-blind, placebo-controlled Phase 2 dose ranging clinical trial that evaluates the efficacy, safety, pharmacokinetics and pharmacodynamics of ESK-001 in patients with moderate to severe plaque psoriasis. The trial has enrolled more than 200 patients across multiple doses of ESK-001 for 12 weeks. The primary endpoint of the trial is the proportion of patients with moderate to severe plaque psoriasis achieving greater than or equal to 75% reduction in PASI score (PASI 75) across doses of ESK-001 and placebo. PASI, or Psoriasis Area and Severity Index, is an instrument used to score, assess and grade the severity of psoriatic lesions and the patient's response to treatment. Enrollment of this trial has been completed.
ESK-001 is a TYK2 inhibitor that reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-a. ESK-001 has the potential to reduce SLE disease activity by interfering with pro-inflammatory pathways known to be involved in the pathogenesis of SLE.
About SLE (Lupus)
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease and is the most common type of lupus. Lupus occurs when the immune system attacks its own tissues, causing inflammation, and in some cases permanent tissue damage, which can be widespread – affecting many parts of the body like the skin, joints, heart, lung, kidneys, circulating blood cells, and brain. Current treatments aim to alleviate symptoms of lupus or reduce inflammation to minimize organ damage; there is no cure for lupus.
About the LUMUS Clinical Trial
LUMUS is a global, multicenter, randomized, double-blind, placebo-controlled Phase 2 trial that is designed to evaluate the efficacy, safety and pharmacokinetics of multiple doses of ESK-001 in adult patients with moderately to severely active, autoantibody-positive SLE. The trial is expected to enroll 388 patients across multiple doses of ESK-001 or placebo for a treatment period of 48 weeks. Following the trial, eligible patients may enroll in an open-label extension study or participate in a four-week safety follow up period. The primary endpoint of the trial will compare the proportion of patients with improvement in BICLA at Week 48 relative to baseline across doses of ESK-001 and placebo. British-Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) is an accepted composite measure of overall SLE disease activity. Secondary endpoints include safety and tolerability, as well as various measures of effect on disease activity. Link to clinicaltrials.gov.
Uveitis was selected as an ideal indication for ESK-001 through the application of our precision analytics. ESK-001 has the potential to play a critical role in the treatment of uveitis where the goal of treatment is to control inflammation in order to prevent vision loss while also limiting the side effects of therapy.
Uveitis is a form of eye inflammation that causes swelling of the uvea, the middle layer of the wall of the eye. Symptoms include eye redness, pain, sensitivity to light and blurred vision. The condition can affect one or both eyes, and it can affect people of all ages, even children. Causes of uveitis include infection, eye injury, or a systemic inflammatory or autoimmune disease such as inflammatory bowel disease (IBD), rheumatoid arthritis or lupus. Uveitis can damage vital eye tissue, leading to permanent vision loss.
About the OPTYK-1 Clinical Trial
The OPTYK-1 clinical trial is a proof-of-concept, multi-center, randomized, double-masked Phase 2 trial that is designed to evaluate the efficacy, safety and pharmacokinetics and pharmacodynamics of multiple doses of ESK-001 in adult patients with active noninfectious intermediate, posterior or panuveitis (uveitis). The trial is designed to treat approximately 30 patients across two doses of ESK-001 for 24 weeks at 20 sites in North America, followed by a 24-week extension period. The primary endpoint is the proportion of patients failing treatment for active non-infectious uveitis (NIU) by Week 24 and will be compared between the two ESK-001 treatment groups. Secondary endpoints include safety and tolerability, as well as various measures of effect on disease activity. Link to clinicaltrials.gov.