Date: 2014-10-20
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at United European Gastroenterology Week in Vienna
Company: Galapagos (Belgium) Janssen Pharmaceutica (J&J) (USA - NJ)
Product: GLPG1205
Action mechanism:
Disease:
Therapeutic area: Inflammatory diseases
Country: Belgium
Trial
details: The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205. The randomized, double-blind, placebo-controlled, single center study will be conducted in 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses will be evaluated. In the second part, the new compound will be administered daily for 14 days. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored. (NCT01887106)
Latest
news:
* On October 20, 2014, Galapagos discloses GPR84 as a promising novel target for treating inflammatory bowel disease during an oral presentation at United European Gastroenterology Week in Vienna on 21 October. Furthermore, Galapagos presents a poster disclosing favorable Phase 1 results with GLPG1205, the first clinical compound ever developed against target GPR84. The discovery of a selective antagonist of GPR84 led to GLPG1205, which shows strong efficacy in relevant pre-clinical models for IBD. GLPG1205 was shown to be safe and well tolerated in healthy volunteers up to 100 mg daily. The drug shows a favorable PK/PD profile, clearly demonstrating the ability of the compound to engage GPR84. Once-daily dosing of GLPG1205 resulted in sustained an extensive full 24-hour inhibition of GPR84 ligand binding.
In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs. These programs include novel targets for inflammatory disorders that were identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of novel compounds acting on those targets. Galapagos is responsible for execution of Phase 1 and Phase 2A studies with compounds in the alliance.* On December 4, 2013, Galapagos has announced that GLPG1205 has demonstrated target engagement, a good safety profile, and favorable drug properties in a Phase 1 study. Galapagos is developing GLPG1205 within its alliance with Janssen Pharmaceutica.
GLPG1205 was safe and well-tolerated over a wide dose range in healthy volunteers. Engagement of the thus far undisclosed novel target was confirmed using a relevant biomarker. GLPG1205 displayed a favorable pharmacokinetic and pharmacodynamic profile, potentially supporting once-daily dosing. The data shown in Phase 1 encourage Galapagos to progress GLPG1205 into a Phase 2A study in Inflammatory Bowel Disease (IBD).
* On July 2, 2013, Galapagos has announced that it has initiated a First-in-Human (FIH) Phase 1 study with GLPG1205 as part of its alliance with Janssen Pharmaceutica. Galapagos expects to disclose topline results from the study by the end of this year. This achievement triggered a milestone payment of €6.6 million to Galapagos, which will contribute to H1 2013 revenues.
In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs. These programs include a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1205, a first-in-class molecule that enters the clinic for inflammatory disorders. Galapagos will be responsible for execution of Phase 1 and Phase 2A studies with GLPG1205.
