• GLPG3667 is an investigational, novel, oral, reversible, and selective tyrosine kinase 2 (TYK2) inhibitor 
  • GLPG3667 is currently in development for the treatment of inflammatory and auto-immune diseases and is in Phase 2 for dermatomyositis 

MECHELEN, Belgium I August 28, 2023 I Galapagos NV (Euronext & NASDAQ: GLPG) today 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. A once-daily oral administration of GLPG3667 or placebo will be investigated in approximately 140 adult patients with SLE for 32 weeks. The primary endpoint is the proportion of patients who achieve the SLE responder index (SRI)-4 response at Week 32. The secondary efficacy endpoints are the proportion of patients who achieve the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32, proportion of patients with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 16, proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and change from baseline in the 28-joint count for tender, swollen, and tender and swollen (active) joints at Week 32.

“We are proud to have reached this important milestone in our journey to improve the lives of patients living with autoimmune diseases. Although significant progress has been made in the management of SLE over the past decade, flares, morbidity, and mortality continue to remain a significant concern and quality of life is poor among patients living with SLE,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head Immunology, at Galapagos. “We are excited about GLPG3667’s potential to make a meaningful difference for people living with SLE and look forward to advancing this candidate medicine in clinical development.”   

GLPG3667 is an investigational drug and is not approved by any regulatory authority. Its efficacy and safety have not been established or fully evaluated by any regulatory authority.

About systemic lupus erythematosus (SLE)
SLE is a chronic, inflammatory, autoimmune disease affecting nearly every organ system and thereby one of the most heterogeneous illnesses treated by physicians1. The pathogenesis of SLE is characterized by a global loss of self-tolerance with activation of autoreactive T and B cells. This leads to the production of pathogenic autoantibodies that primarily target a variety of nuclear antigens, deposit in tissues and activate complement, resulting in organ damage. SLE affects women more frequently than men and is more prevalent and severe (with higher disease activity and more damage accrual) in non-Caucasian populations (Hispanics, African descendants, and Asians)2. SLE has periods of relatively stable disease followed by flares that may induce irreversible organ damage. Despite best practice, most patients accrue irreversible organ damage within 7 years of diagnosis. SLE has no cure and current treatment options are associated with partial efficacy and/or substantial toxicities. New treatments may help to fulfill the current unmet medical needs among patients. 

About Galapagos
Galapagos is a fully integrated biotechnology company united around a single purpose: to transform patient outcomes through life-changing science and innovation for more years of life and quality of life. We focus on the key therapeutic areas of immunology and oncology, where we have developed deep scientific expertise in multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs and our first medicine for rheumatoid arthritis and ulcerative colitis is currently available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter

SOURCE: Galapagos