Alumis begins patient dosing in OPTYK-1 Phase 2 clinical trial for the treatment of uveitis

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This allosteric tyrosine kinase (TYK2) inhibitor may help to treat the disregulation of TYK2 mediated pathways may also play an important role in conditions, including noninfectious uveitis.

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This allosteric tyrosine kinase (TYK2) inhibitor may help to treat the disregulation of TYK2 mediated pathways may also play an important role in conditions, including noninfectious uveitis.(Image Credit: Rawpixel.com/Adobe Stock)

Alumis Inc. has commenced patient doing in OPTYK-1, a proof-of-concept Phase 2 clinical trial for noninfectious uveitis. ESK-001 is Alumis’ proprietary lead clinical candidate and is a highly selective and potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor.

Uveitis is a form of eye inflammation that causes swelling of the uvea, the middle layer of the wall of the eye. Uveitis is commonly associated with systemic immune mediated diseases such as psoriasis, rheumatoid arthritis, Crohn’s disease and sarcoidosis, in which dysregulation of TYK2 mediated pathways may also play an important role. The Phase 2 uveitis clinical trial is proof-of-concept, multi-center, randomized, double-masked, trial that is designed to evaluate the efficacy, safety and pharmacokinetics and pharmacodynamics of two doses of ESK-001 in adult patients with active noninfectious intermediate, posterior or panuveitis (uveitis). 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.

Jörn Drappa, MD, PhD, Alumis’ chief medical officer weighed in on this trial saying, “Leveraging our proprietary precision data analytics and multi-platform approach, we determined that uveitis would be a compelling indication for several reasons. We see an opportunity to reach patients in need of more effective, oral therapeutics, in a disease with well-defined outcome measures in which TYK2 is likely to be an important driver. Data generated in this study may also inform how we can best advance ESK-001 into larger, more complex indications that may also be addressed by TYK2 inhibition. Furthermore, our precision approach includes evaluation of genomic and proteomic data to guide our TYK2 development for other indications such as inflammatory bowel disease and psoriatic arthritis.”

Alumis now has three ongoing Phase 2 clinical trials evaluating ESK-001 including the STRIDE clinical trial (NCT05600036) in patients with moderate to severe plaque psoriasis, from which data are anticipated in the third quarter of 2023. Alumis continues to leverage its precision data analytics and a multi-platform approach to explore ESK-001’s potential application in other autoimmune indications.

About Uveitis

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 ESK-001

Alumis’s lead clinical candidate, ESK-001 is an allosteric tyrosine kinase 2 (TYK2) inhibitor that reduces signaling through several cytokine receptors including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-a. ESK-001 is a highly selective and potentially best-in-class allosteric TYK2 inhibitor. In Alumis’ Phase 1 studies, ESK-001 demonstrated complete inhibition of the pharmacodynamic assay over the dosing schedule of 24 hours, with no observed JAK-related safety events to date. ESK-001 was well-tolerated in these studies, with no serious adverse events observed.

Reference:
Alumis Announces Expansion of Allosteric TYK2 Inhibitor, ESK-001, Phase 2 Program into Systemic Lupus Erythematosus (SLE) and Uveitis. Alumnis Inc. June 29, 2023. Accessed July 6, 2023. https://www.biospace.com/article/releases/alumis-announces-expansion-of-allosteric-tyk2-inhibitor-esk-001-phase-2-program-into-systemic-lupus-erythematosus-sle-and-uveitis/
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