Wednesday May 24th 2023



Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was dosed in GALARISSO, the Phase 2 dermatomyositis (DM) trial with GLPG3667.

  • 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

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.

(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.