• 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, if approved, has the potential to be the first selective oral TYK2 inhibitor in dermatomyositis

MECHELEN, Belgium I May 23, 2023 I Galapagos NV (Euronext & NASDAQ: GLPG) today 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. A daily oral administration of GLPG3667 150mg or placebo will be investigated in approximately 62 adult patients with DM over 24 weeks. The primary endpoint is the proportion of patients with at least minimal improvement in the signs and symptoms of DM at Week 24 according to the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) criteria.1

“We remain committed to delivering transformational medicines to patients living with severe immunological disorders and are pleased to further advance our novel, orally administered TYK2 inhibitor, GLPG3667, into Phase 2 development in dermatomyositis,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos. “Dermatomyositis is a debilitating inflammatory disease marked by muscle weakness and a distinctive skin rash that can severely impact patients’ daily lives. There is a significant unmet need for effective and convenient treatment options for patients living with this rare disease, and we hope that our novel drug-candidate can help address this need and improve patient outcomes.”

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 dermatomyositis
Idiopathic inflammatory myopathies (IIM) are a heterogenous group of rare autoimmune disorders primarily affecting the proximal muscles. They are characterized by severe muscle weakness, muscle enzyme elevations, inflammation on muscle biopsy, and extra-muscular manifestations. DM is the most common form of IIM and is characterized by inflammatory and degenerative changes of the muscles and skin. Early symptoms of DM include distinct skin manifestations accompanying or preceding muscle weakness. The quality of life (QoL) of patients with DM is impaired due to muscle weakness, pain and skin disease activity.2 The overall mortality ratio in DM patients also remains three times higher when compared to the general population; with cancer, lung, and cardiac complications and infections being the most common causes of death.3 DM-specific prevalence has been estimated at one to six per 100,000 adults in the United States, and a recent analysis of 3,067 patients in the Euromyositis registry identified DM in 31% of the sampled patients.4 DM is a rare disease and with only one currently approved treatment, there is a high unmet need for alternative safe and effective treatment options.

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 a 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 available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.

1 Minimal improvement per ACR/EULAR is defined as a total improvement score (TIS) of >= 20 points. The TIS is a score derived from the evaluation of the results from 6 core set measurements of myositis disease activity.
2 Goreshi R, et al. Quality of life in dermatomyositis. J Am Acad Dermatol. 2011 Dec;65(6):1107-16.
3 Marie I. et al. Morbidity and mortality in adult polymyositis and dermatomyositis. Curr Rheumatol Rep. 2012 Jun;14(3):275-85.
4 DeWane ME, et al. Dermatomyositis: Clinical features and pathogenesis. J Am Acad Dermatol. 2020 Feb;82(2):267-281.

SOURCE: Galapagos