cadefrecitinib (GLPG3667) / Lakefront Biotherapeutics, Gilead - LARVOL DELTA

Efficacy, Safety, Tolerability and Pharmacodynamic Effect of Orally Administered GLPG3667 in Adults with Dermatomyositis: the GALARISSO study (ACR Convergence 2026) - No abstract available

Clinical • PK/PD data • Dermatomyositis • Immunology • Myositis

EFFICACY, SAFETY and TOLERABILITY OF ORALLY ADMINISTERED GLPG3667 IN ADULTS WITH DERMATOMYOSITIS: THE GALARISSO STUDY (EULAR 2026) - "The results demonstrate that TYK2 inhibition with GLPG3667 in DM leads to significant improvements in endpoints related to disease activity. These findings support further evaluation of GLPG3667 in DM."

Clinical • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rare Diseases • Systemic Lupus Erythematosus • TYK2

GLPG3667-CL-122: Thorough QT/QTc study with GLPG3667, placebo, and active comparator in healthy subjects (clinicaltrialsregister.eu) - P1 | N=25 | Not yet recruiting | Sponsor: Galapagos

New P1 trial

GALACELA: A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=186 | Completed | Sponsor: Galapagos NV | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Pharmacological Characterization of GLPG3667, a Tyrosine Kinase 2-Selective Inhibitor, for the Treatment of Inflammatory and Autoimmune Diseases. (PubMed, Inflammation) - "Pharmacodynamic analyses performed during phase 1 trials, in which healthy volunteers received GLPG3667 orally, confirmed the selectivity of the compound for TYK2-dependent pathways. In addition, following an in vivo challenge in these healthy volunteers, GLPG3667 inhibited the biological effects of interferon-α, supporting its potential use in treating several inflammatory and autoimmune diseases."

Journal • Immunology • IL10 • IL12A • IL23A • TYK2

GALARISSO: A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Galapagos NV | Active, not recruiting ➔ Completed

Trial completion • Dermatomyositis • Immunology • Myositis

GALARISSO: A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Galapagos NV | Active, not recruiting ➔ Completed | Completed ➔ Active, not recruiting

Enrollment closed • Trial completion • Dermatomyositis • Immunology • Myositis

GLPG3667-CL-120: Relative bioavailability and effect of food study with GLPG3667 in healthy subjects (clinicaltrialsregister.eu) - P1 | N=16 | Not yet recruiting | Sponsor: Galapagos

New P1 trial • Immunology

In the systemic lupus erythematosus study, GLPG3667 delivered numerical improvements on several secondary endpoints compared to placebo but did not achieve statistical significance in primary endpoint analysis (GlobeNewswire) - "In the GALACELA SLE study, GLPG3667, administered once daily at 75 mg (N=59) and 150 mg (N= 64) in addition to standard-of-care therapy, the primary endpoint analysis of dose-response on SLE responder index (SRI)-4 at Week 32 did not meet statistical significance. However, GLPG3667 showed numerical improvements over placebo (N=63) on several secondary endpoints, particularly on skin-related outcomes....The GALACELA study is currently ongoing, and the final Week 48 data, expected in the second quarter of 2026, will be essential to assess the totality of the evidence and determine potential next steps for the SLE program."

P2 data • Systemic Lupus Erythematosus

GLPG3667 met primary endpoint in dermatomyositis study, demonstrating a statistically significant clinical benefit and meaningful improvements on secondary measures of disease activity compared to placebo (GlobeNewswire) - "The GALARISSO DM study met its primary endpoint, showing that GLPG3667, administered once daily at 150 mg (N=21) in addition to standard-of-care therapy, achieved a statistically significant clinical benefit in the Total Improvement Score (TIS)1 at Week 24 (p=0.0848; Δ: 14.26), compared to placebo (N=19). The pre-specified threshold of statistical significance was set at 10% (α=0.1). GLPG3667 also showed meaningful clinical improvements compared to placebo on several secondary endpoints of disease activity, including TIS20, TIS40, TIS60 and m-CDASI-A."

P2 data • Dermatomyositis

GLPG3667, a small molecule TYK2 inhibitor in two Phase 3-enabling studies in systemic lupus erythematosus (SLE) and dermatomyositis (DM) (GlobeNewswire) - "Both the SLE and DM studies have progressed well, and topline data from both studies are expected in early 2026."

P2 data • Dermatomyositis • Systemic Lupus Erythematosus

Galapagos to Present In Vitro Data at ACR Convergence 2025 Suggesting Differentiation of GLPG3667 from Other TYK2 Inhibitors (GlobeNewswire) - "The data show that the in vitro pharmacological profile of GLPG3667 suggests differentiation from other TYK2 inhibitors at their clinical dose regimens."

Preclinical • Dermatomyositis • Systemic Lupus Erythematosus

In Vitro Pharmacological Profile of GLPG3667 Suggests Differentiation from the TYK2 Inhibitors Deucravacitinib and Zasocitinib at Their Clinical Dose Regimens (ACR Convergence 2025) - "At concentrations corresponding to its highest anticipated clinical dose, GLPG3667 shows selective inhibition of TYK2-mediated signalling, with a level of inhibition similar to deucravacitinib clinical dose regimens. While GLPG3667 did not show any impact on IL-10-mediated signalling, inhibition of this anti-inflammatory pathway is expected for the allosteric TYK2 inhibitors at their clinical exposure levels."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CD4 • IFNA1 • IL10 • IL12A • IL2 • IL23A • IL6 • JAK1 • TYK2

SECOND QUARTER 2025 AND RECENT BUSINESS UPDATE (Galapagos Press Release) - "Galapagos is actively exploring partnership opportunities for GLPG3667, a small molecule TYK2 inhibitor currently in Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM). Topline results from ongoing studies with GLPG3667 are expected during the first half of 2026."

P2 data • Dermatomyositis • Systemic Lupus Erythematosus

GALARISSO: A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Galapagos NV | N=62 ➔ 40 | Trial primary completion date: Jan 2026 ➔ Oct 2025 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Trial primary completion date • Dermatomyositis • Immunology • Myositis

GALACELA: A Study Evaluating the Effects of GLPG3667 Administered As Oral Treatment in Adult Participants with Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=186 | Active, not recruiting | Sponsor: Galapagos NV | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

GALARISSO: A Study Evaluating the Effects of GLPG3667 Given As Oral Treatment for Up to 24 Weeks in Adults with Dermatomyositis (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Galapagos NV | Trial completion date: Mar 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

Galapagos Reports Full Year 2024 Results and Provides Fourth Quarter Business Update (GlobeNewswire) - "SMALL MOLECULE PORTFOLIO: Galapagos is advancing its TYK2 inhibitor, GLPG3667, in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM). Screening for the SLE study was completed in January 2025, ahead of schedule. Topline results for the entire GLPG3667 program are anticipated in the first half of 2026. Following the planned strategic reorganization as announced early this year, Galapagos is seeking potential partners to take over its small molecule assets, including GLPG3667 for SLE, DM, and other potential auto-immune indications."

Commercial • P2 data • Trial status • Dermatomyositis • Systemic Lupus Erythematosus

Discovery of GLPG3667, a Selective ATP Competitive Tyrosine Kinase 2 Inhibitor for the Treatment of Autoimmune Diseases. (PubMed, J Med Chem) - P1, P2 | "Dermal ear inflammation was reduced in an IL-23-induced in vivo mouse model of psoriasis. GLPG3667 also completed a phase 1b study (NCT04594928) in patients with moderate-to-severe psoriasis where clinical effect was shown within the 4 weeks of treatment and it is now in phase 2 trials for the treatment of dermatomyositis (NCT05695950) and systemic lupus erythematosus (NCT05856448)."

Journal • Dermatology • Dermatomyositis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Psoriasis • Systemic Lupus Erythematosus • IL10 • IL23A • TYK2

GLPG3667: Expiry of patents in US/ex-US related to composition-of-matter and methods of treatment in 2038 (Galapagos) - Annual Report 2023: Expiry of patents in US/ex-US related to dosage regimen in 2042

Patent • Lupus

In vitro pharmacological profile of GLPG3667 suggests differentiation from the TYK2 inhibitors deucravacitinib and TAK-279 at their clinical dose regimens (ECCO-IBD 2024) - "Conclusion At concentrations corresponding to its highest anticipated clinical dose, GLPG3667 shows selective inhibition of TYK2-mediated signalling, with a level of inhibition similar to deucravacitinib clinical dose regimens. While GLPG3667 did not show any impact on IL-10-mediated signalling, inhibition of this anti-inflammatory pathway is expected for the allosteric TYK2 inhibitors at their clinical exposure levels."

Preclinical • Inflammatory Bowel Disease • IFNA1 • IL10 • IL12A • IL2 • IL6 • JAK1 • TYK2

GALACELA: A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Galapagos NV

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

GALARISSO: A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Galapagos NV

Trial completion date • Trial primary completion date • Dermatomyositis • Immunology • Myositis

GALACELA: A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Galapagos NV | Trial completion date: Oct 2025 ➔ Apr 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with active systemic lupus erythematosus (GlobeNewswire) - "Galapagos NV...announced that the first patient was randomized in GALACELA, a Phase 2 systemic lupus erythematosus (SLE) trial with GLPG3667. The GALACELA Phase 2 trial (NCT05856448) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3667 in adults with active SLE."

Trial status • Immunology • Lupus • Systemic Lupus Erythematosus