Armis Presents Positive Data from Phase 2 Clinical Trial of Oral Allosteric TYK2 Inhibitor ESK-001 for Treatment of Plaque Psoriasis at AAD Annual Meeting

– STRIDE Phase 2 PASI 75 primary endpoint and key secondary endpoints were met at all clinically relevant doses tested. Safely achieve sustained maximal target inhibition at the highest doses –

– Previous open label extension (OLE) study data show increased PASI response over time, with high efficacy response of 80-90% of PASI 75 at the highest dose and best-in-class A continued favorable safety profile has been shown to support the potential of a –

~ Phase 3 clinical trial of ESK-001 scheduled to begin in the second half of 2024 ~

– Alumis will host a webcast on March 9th at 5pm PT/8pm ET –

SOUTH SAN FRANCISCO, Calif., March 9, 2024 (Globe Newswire) — Alumis Inc., a clinical-stage biopharmaceutical company developing oral treatments using precision approaches to transform the lives of patients with immune-mediated diseases. gave a presentation today. Positive clinical data from a Phase 2 clinical trial of ESK-001, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. These data were presented during a later session of the American Academy of Dermatology (AAD) Annual Meeting, held March 8-12 in San Diego, California.

The STRIDE trial enrolled 228 patients who were randomized to one of five ESK-001 dose cohorts or placebo. The study measured the primary endpoint, the proportion of patients achieving a 75% improvement in Psoriasis Area and Severity Score (PASI 75) at week 12 compared to placebo at all clinically relevant doses tested. , and achieved key secondary efficacy endpoints. A clear dose-dependent response was observed, with maximum efficacy and TYK2 inhibition achieved at the highest dose of 40 mg twice daily. ESK-001 was found to be generally well tolerated at all dose levels.

In the ongoing open-label extension (OLE) trial evaluating two doses of ESK-001 (40 mg once daily and 40 mg twice daily), preliminary data from 16 weeks of treatment show that We demonstrate a significant increase in PASI endpoint response over time in a large number of patients. At her twice daily dose of 40 mg (90% of evaluable patients, 80% used non-responder imputation) he achieved PASI 75 and continued good safety profile. did. These data support a Phase 3 clinical trial of ESK-001 in moderate to severe plaque psoriasis, scheduled to begin in late 2024.

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“The Phase 2 clinical program was designed to evaluate the impact of varying degrees of target inhibition on safety and clinical efficacy in psoriasis. We are pleased that this led to a high degree of clinical improvement at week 12, which continued to improve over time,” said Dr. Jörn Drappa, Chief Medical Officer at Alumis. . “We are very excited about the risk-benefit profile observed in our Phase 2 program. These very encouraging data highlight the potential of his ESK-001’s best-in-class profile in psoriasis. I support it.”

“Since I began my clinical practice many years ago, I have seen firsthand the challenges faced by patients with psoriasis. “A well-tolerated, safe oral treatment with biologic-like efficacy represents a true innovation in psoriasis treatment. TYK2 inhibitors have the potential to achieve that goal.” We are excited about this,” said Dr. Kim Papp, founder and president of Probity Medical Research and clinical investigator on the STRIDE clinical trial. ”

“Importantly, in the Phase 2 study, the ESK-001 dose cohort demonstrated the full spectrum of TYK2 target inhibition and its translation into efficacy,” said Martin Babler, president and chief executive officer of Alumis. This is confirmed by the decision,” he added. It was observed that high efficacy in the biologic range requires maximal target inhibition throughout the 24-h dosing period, achieved at the highest dose. Doses that failed to achieve maximal target inhibition led to significant reductions in long-term efficacy. This prompted the initiation of a Phase 3 clinical trial aimed at providing a more effective oral treatment compared to existing treatments, not only for patients with psoriasis, but also for patients with other immune-mediated diseases. It gives us confidence as we prepare for the future. ”

Data from the STRIDE Phase 2 clinical trial are summarized below.

• The trial met its primary endpoint of PASI 75 at week 12 compared to placebo and met important secondary efficacy endpoints at all clinically relevant doses tested.

• A clear dose-dependent response was observed, consistent with an increase in the level of target inhibition.

*p<0.05; **p<0.005; ***p<0.001; BID = twice a day, QD = once a day

• ESK-001 treatment response continued to improve over time, reaching maximum efficacy after week 24. This is consistent with the PASI 75 results regarding psoriasis treatment regardless of mechanism.

• Treatment with ESK-001 was well tolerated, with no serious treatment-related adverse events. The incidence of treatment-related AEs was similar between his ESK-001 and placebo, and the majority of adverse events that occurred during treatment were mild or moderate in severity. There was no evidence of adverse events related to JAK inhibition. Discontinuation rates due to AEs were low (<3%). The most common AEs were headache, upper respiratory tract infection, and nasopharyngitis.

• At a dose of 40 mg twice daily, ESK-001 RNA-seq data showed maximal target inhibition in both plasma and skin biopsies.

Data from ongoing OLE studies as of December 8, 2023 are summarized as follows:

• Data show that PASI endpoint responses were significantly increased and ESK-001 continues to be well tolerated for up to 28 weeks of treatment.

• At 16 weeks on 40 mg twice daily, the majority of patients (90% of evaluable patients, 80% of patients using non-responder imputation) achieved PASI 75.

*NRI: Non-responder imputation

ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial of ESK-001 for the treatment of patients with systemic lupus erythematosus (SLE)., and OPTYK-1, a proof-of-concept Phase 2 clinical trial in non-infectious uveitis. Additionally, Alumis continues to explore the potential applications of her ESK-001 in other autoimmune diseases, leveraging precision data analysis and multi-platform approaches. Alumis is also developing his once-daily tablet for his ESK-001.

Webcast details
Alumis will host an investor event webcast to discuss these data on March 9, 2024 at 5:00 PM PT. To access the webcast, please register on the event page on the Alumis website.

About the STRIDE clinical trial and an open-label extension study.
The STRIDE study (NCT05600036) was a randomized, double-blind study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ESK-001 in patients with moderate to severe plaque psoriasis. A placebo-controlled phase 2 dose-ranging clinical trial. The study enrolled 228 patients across his five doses of ESK-001: 10 mg QD, 20 mg QD, 40 mg QD, 20 mg BID, and 40 mg BID. Patients received ESK-001 or placebo for 12 weeks, with a 4-week follow-up period of treatment discontinuation. The primary endpoint of this study was the proportion of patients with moderate to severe plaque psoriasis who achieved a 75% or greater reduction in PASI (PASI 75) across doses of ESK-001 compared to placebo. PASI (Psoriasis Area and Severity Index) is an instrument used to score, evaluate, and grade the severity of psoriatic lesions and patient response to treatment. Key secondary endpoints include safety and tolerability, PASI 90, PASI 100, and Static Physician Global Assessment (sPGA) scores. sPGA assesses disease severity at a specific point in time. An sPGA score of 1 indicates nearly clear skin and 0 indicates completely clear skin. Upon completion of the clinical trial, including a 4-week treatment withdrawal follow-up period, patients will be eligible to enroll in the open-label extension (OLE) study (NCT05739435).) Evaluating two doses of ESK-001. In his ongoing OLE, 164 patients were randomized to receive her 40 mg once daily or 40 mg twice daily. The primary endpoints are safety and tolerability, and secondary endpoints include his PASI and DLQI scores and pharmacokinetic measurements.

About psoriasis
Psoriasis is a chronic autoimmune inflammatory skin disease that can affect any part of the body. Plaque psoriasis, the most common type of psoriasis, causes red, dry, scaly skin patches (plaques) that can be itchy and painful. The severity of the disease depends on the intensity of symptoms. Moderate to severe disease has a significant negative impact on quality of life, and almost a quarter of people with psoriasis are thought to have moderate to severe disease.

About ESK-001
Alumis’ lead clinical candidate, ESK-001, is a highly selective and perhaps best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor that inhibits several cytokine receptors, including receptors for interleukin (IL)-12, IL-23, and interferon (IFN)-α. Reduces signaling through the body. In Alumis’ Phase 1 study, ESK-001 showed maximal inhibition of pharmacodynamic assays over his 24-hour dosing schedule, with no Janus kinase (JAK)-related safety events observed to date. . ESK-001 was well tolerated in these studies, and no serious adverse events were observed.

About aluminum
Alumis is a clinical-stage biopharmaceutical company that uses precision approaches to optimize outcomes and develop life-changing oral treatments for patients with immune-mediated diseases. Alumis leverages precision data analysis and a multi-platform approach to advance its pipeline of oral therapies designed to address immune dysfunction. Alumis’ lead candidate ESK-001 is a highly selective, potentially best-in-class allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate to severe plaque psoriasis, systemic lupus erythematosus (SLE), and Non-infectious uveitis. Almis is also developing A-005, a potential first-in-class brain-penetrating allosteric TYK2 inhibitor for the treatment of neuroinflammatory and neurodegenerative diseases, with the first We are planning to enter phase clinical trials. Addressing unpublished immune-mediated diseases and targets identified by data analysis platforms. Forged by Foresite Labs and led by a team of experts with deep experience and proven expertise in drug discovery, development, and immunology, Alumis is an innovative therapy aimed at reimagining the lives of people with immune-mediated diseases. is being developed. For more information, please visit alumis.com.

Alumis contact information

Terry Dahlman
red house communications
teri@redhousecomms.com