Alumis Announces Initiation of Patient Dosing in Phase 2 Clinical Trial of ESK-001 for the Treatment of Plaque Psoriasis
– Phase 2 Initiation Supported by Positive Data from Phase 1 Studies in which ESK-001 was Generally Well-Tolerated and Demonstrated Full, Sustained TYK2 Inhibition –
SOUTH SAN FRANCISCO, Calif. – Alumis Inc., a precision immunology company that is reimagining the discovery, development and treatment of autoimmune disorders, today announced that the first patient has been dosed in Stride, a Phase 2 clinical trial of ESK-001 for the treatment of patients with moderate to severe plaque psoriasis. ESK-001 is a highly selective and potentially best in class allosteric tyrosine kinase 2 (TYK2) inhibitor.
Initiation of the Phase 2 trial is supported by data from Phase 1 studies in more than 100 healthy volunteers. ESK-001 demonstrated selective, full and sustained inhibition of TYK2, with no pharmacological inhibition of JAK1/2/3 and no observed JAK-related safety events to date. Across the Phase 1 program, ESK-001 was generally well-tolerated, with no serious adverse events observed.
“The initiation of the Stride Phase 2 trial marks an important milestone for patients with immune-mediated diseases, as this is the first use of ESK-001 in an autoimmune disorder,” said Martin Babler, chief executive officer of Alumis. “ESK-001 has the potential to offer an oral therapy with superior efficacy compared to other available or investigational treatments for plaque psoriasis. We’re highly encouraged by the data from our Phase 1 studies, in which administration of ESK-001 demonstrated high selectivity and the ability to achieve full TYK2 target inhibition. We are excited to advance the clinical development of this program and gain further understanding of the ultimate impact we may have for patients who are in need of more effective oral treatment options.”
The Stride trial is a randomized, double-blind, placebo-controlled Phase 2 dose ranging trial that will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ESK-001 in patients with moderate to severe plaque psoriasis. The trial will enroll 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.
Beyond psoriasis, Alumis is leveraging its precision immunology platform to explore ESK-001’s potential application in other autoimmune indications. The company plans to initiate additional Phase 2 trials in the near future.
ESK-001 is Alumis’ lead precision immunology candidate, designed to be a highly selective and potentially best in class tyrosine kinase 2 (TYK2) inhibitor with greater selectivity for TYK2 over JAK1 compared to currently available treatments or therapies in clinical development. In the company’s Phase 1 studies, ESK-001 demonstrated selective, full and sustained inhibition of TYK2, with no pharmacological inhibition of JAK1/2/3 and no observed JAK-related safety events to date. ESK-001 was well-tolerated in these studies, with no serious adverse events observed.
Alumis is a precision immunology company looking to eliminate the “all comer” approach that is seen with today’s treatments for people with autoimmune disease. Even with innovation of the last decade, many patients cycle through the approved therapies while continuing to look for the right therapy to alleviate the impact of their disease without life-impacting side effects. Alumis leverages a precision analytics platform, powered by Foresite Labs, coupled with a team of experts with deep experience in precision medicine drug discovery, development and immunology, in order to create medicines that change the lives of people with autoimmune disease. For more information, please visit alumis.com.
Dan Budwick, 1AB