Galapagos NV (NASDAQ: $GLPG) unveils the Toledo target family as a series of salt-inducible kinase inhibitors. Toledo demonstrates a dual mechanism of action characterized by stimulation of anti-inflammatory cytokines and inhibition of pro-inflammatory cytokines. Galapagos also presented new preclinical data and results in healthy volunteers today. Furthermore, it explains its broad program to discover and develop multiple Toledo ranges with different selectivity profiles for the treatment of a wide variety of autoimmune diseases with important unmet medical needs.
“The discovery of the SIK target family in our dual layer assays a few years ago parallels the scientific literature that points to the dual modes of action of SIKs in inflammatory diseases,” said Dr. Piet Wigerinck, Chief Scientific Officer at Galapagos. “Galapagos has developed innovative chemistry to address a number of selectivity profiles. We also show promising preclinical activity in fibrotic models, further broadening the scope of the Toledo program into a second disease paradigm. For this, we have built up substantial scientific know-how over the years. In the phase 1 study, we demonstrated a favorable PK profile and confirmed the dual mechanism of action, and observed a dose-dependent effect ex vivo in healthy volunteers. ”
“We generated the data package to confidently test our first Toledo compound, GLPG3970, in multiple parallel patient studies. The Calosoma psoriasis study, the Sea Turtle ulcerative colitis study and the Ladybug rheumatoid arthritis study are currently actively recruiting patients, and we aim to have two additional phase 2 studies in Sjögren’s syndrome early next year. and systemic lupus erythematosus,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “We will continue to take a programmatic approach, learning from the various patient studies and the biomarkers from our comprehensive development plan. By building our knowledge with rapid signal detection studies, we aim to understand and expand the potential of our Toledo program to become a new paradigm in the treatment of inflammatory and fibrotic diseases. ”
Calosoma Study: Phase 1 Program in Psoriasis
The Calosoma Phase 1 Study (NTC04106297) is a double-blind, placebo-controlled study evaluating the safety, tolerability, PK and PD1 of single and multiple escalating doses of GLPG3970 in up to 52 healthy male adults. GLPG3970 is now being studied for 6 weeks in up to 25 patients with moderate to severe psoriasis. The first patient was recently dosed.
Sea Turtle Study: Phase 2 Program in Ulcerative Colitis (CU)
This Phase 2 study is a double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, PK and PD of GLPG3970 in up to 30 patients with moderately to severely active UC. GLPG3970 or placebo will be administered orally once daily for 6 weeks. The primary endpoint is the difference from baseline in the total Mayo Clinical Score (MCS).
Ladybug Study: Phase 2 Program in Rheumatoid Arthritis (RA)
This Phase 2 study is a double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, PK and PD of GLPG3970 in up to 25 participants with severe active RA and inadequate response to methotrexate. GLPG3970 or placebo will be administered orally once daily for 6 weeks. The primary endpoint is the difference from baseline in the DAS28 CRP at week 6. Currently, GLPG3970 is a drug under development whose efficacy and safety has not been demonstrated yet.
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