Galapagos reports positive topline results with selective TYK2 inhibitor GLPG3667 in Phase 1b psoriasis study
- Category: Small Molecules
- Published on Thursday, 15 July 2021 09:31
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- Generally safe and well tolerated
- Positive efficacy signal in psoriasis patients at Week 4
- 40% of patients showed improvement of at least 50% in PASI response (PASI 50) with high dose of GLPG3667 at Week 4
- Data support initiation of Phase 2b dose finding study in psoriasis
MECHELEN, Belgium I July 14, 2021 I Galapagos NV (Euronext & Nasdaq: GLPG) reports positive topline results with tyrosine kinase 2 (TYK2) inhibitor GLPG3667 in a Phase 1b study in psoriasis patients. GLPG3667 was discovered by Galapagos.
Galapagos evaluated GLPG3667, a proprietary selective TYK2 compound, in a randomized, placebo-controlled, double-blind Phase 1b study in 31 patients with diagnosis of moderate to severe plaque psoriasis. Patients were randomized in a 1:1:1 ratio to a daily oral dose of GLPG3667 (low dose or high dose) or placebo, for a total of four weeks. Main objectives were to evaluate the safety and tolerability of GLPG3667 as well as signs of clinical activity at Week 4.
GLPG3667 was well tolerated in this Phase 1b trial. One patient in the low dose group interrupted the study for one day for exacerbation of psoriasis. The majority of treatment related adverse events (AEs) were mild in nature and transient. There were no deaths or serious adverse events (SAEs) in this 4-week study. At Week 4, four out of 10 patients in the high dose group had a PASI1 50 response, defined as at least a 50% improvement in PASI from baseline, compared to one out of 10 subjects on placebo. There were no subjects with a PASI 50 response on the low dose of GLPG3667. The four responders in the high dose group of GLPG3667 achieved a 52%, 65%, 74% and 81% improvement respectively in their PASI scores from baseline, while the subject randomized to placebo improved by 52%. Positive efficacy signals were also observed with the high dose for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 4.
“We are pleased with the efficacy signal and safety profile observed with GLPG3667 in patients with psoriasis over a 4-week period,” said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. “Based on these results, we aim to initiate a global Phase 2b program in psoriasis next year as part of a program to develop our selective oral TYK2 inhibitor GLPG3667 broadly in inflammatory indications.”
“The PASI 50 scores and other efficacy data after only four weeks of treatment, combined with the safety profile observed, are very supportive for moving this compound into a larger trial in psoriasis. People living with psoriasis remain in need of alternative treatments, especially oral ones,” said Prof. Dr. Diamant Thaci, Professor of Medicine at the Comprehensive Center for Inflammation Medicine, University of Lübeck, Germany.
Galapagos intends to submit study outcomes with GLPG3667 for publication at scientific conferences and in peer-reviewed medical journals.
GLPG3667 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.
Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through to Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.