GLPG3667 / Galapagos, Gilead - LARVOL DELTA

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

GALACELA: A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Galapagos NV | Not yet recruiting ➔ Recruiting

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

Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with dermatomyositis (GlobeNewswire) - "Galapagos NV...announced that the first patient was dosed in GALARISSO, the Phase 2 dermatomyositis (DM) trial with GLPG3667. The GALARISSO Phase 2 trial (NCT05695950) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667."

Trial status • Dermatology • Dermatomyositis • Immunology

PHARMACOLOGICAL CHARACTERIZATION OF GLPG3667, A SELECTIVE TYK2 INHIBITOR, SUPPORTS DEVELOPMENT IN DERMATOMYOSITIS AND SYSTEMIC LUPUS ERYTHEMATOSUS (EULAR 2023) - P1 | "In addition, clinical data obtained with deucravacitinib (a TYK2 selective inhibitor) in SLE patients suggest that inhibition of TYK2 could be beneficial to patients with diseases driven by type I IFN such as systemic lupus erythematosus (SLE) and dermatomyositis (DM)...Pharmacological effects of GLPG3667 were demonstrated in a mouse model of psoriasis driven by IL-23 and in human healthy volunteers challenged with IFNα. These data support the development of GLPG3667 in autoimmune diseases driven by type I IFN such as DM and SLE."

Dermatology • Dermatomyositis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Psoriasis • Systemic Lupus Erythematosus • IFNA1 • IL10 • IL2 • IL23A • STAT1 • STAT5 • 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=140 | Not yet recruiting | Sponsor: Galapagos NV

New P2 trial • 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 | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatomyositis • Immunology • Myositis

Galapagos announces full year 2022 results and outlook for 2023 (BioSpace) - "We aim to recruit the first patients in the Phase 2 programs with our TYK2 inhibitor product candidate, GLPG3667, in DM in the first quarter of 2023, followed by the start of a study in SLE later this year."

Enrollment status • New P2 trial • Dermatomyositis • Immunology • 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 | Not yet recruiting | Sponsor: Galapagos NV

New P2 trial • Dermatomyositis • Immunology • Myositis

Galapagos announces strategy to accelerate innovation and reports strong third quarter 2022 results (Galapagos Press Release) - "We aim to recruit the first patients in a Phase 2 study of our TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis around year-end, and we intend to start a Phase 2 study in patients with Systemic Lupus Erythematosus (SLE) in 2023."

New P2 trial • Dermatomyositis • Immunology • Systemic Lupus Erythematosus

First key steps in pipeline rebuild and strong commercial progress in H1 2022 (GlobeNewswire) - "Decided to move forward with GLPG3667 (TYK2 inhibitor) in dermatomyositis with the aim to start a Phase 2 study before year-end"

New P2 trial • Dermatomyositis • Immunology

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667 (clinicaltrials.gov) - P1 | N=5 | Completed | Sponsor: Galapagos NV | Recruiting ➔ Completed

Trial completion

Drug-drug Interaction Study With GLPG3667 and Itraconazole in Healthy Subjects (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Galapagos NV | Recruiting ➔ Completed

Trial completion

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667 (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Galapagos NV | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667 (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Galapagos NV

New P1 trial

[VIRTUAL] Pharmacological Characterization of GLPG3667, a Selective TYK2 Inhibitor for Treatment of Inflammatory Diseases (ACR-CONVERGENCE 2021) - P1 | "In addition, clinical data obtained with ustekinumab suggest that compounds that inhibit TYK2 could be potential treatments for inflammatory diseases, notably through inhibition of IL-12 and IL-23 signaling... The TYK2 inhibitor GLPG3667 demonstrated selectivity toward the three other JAK family members in several biochemical, cellular and human whole blood assays ex vivo and in vivo during a Phase 1 study (NCT04097938) in healthy HV. Pharmacological effects of GLPG3667 were demonstrated in a mouse model of psoriasis driven by IL-23 and in healthy HV challenged with IFNα. GLPG3667 is in development for the treatment of moderate to severe psoriasis."

Dermatology • Immunology • Inflammation • Psoriasis • IFNA1 • IL10 • IL12A • IL2 • JAK2 • STAT1 • STAT5 • TYK2