Galapagos has launched a Phase 2 trial testing the safety and effectiveness of their investigational new therapy called GLPG1205 in patients with idiopathic pulmonary fibrosis (IPF), reporting that the first participant has now received the therapy.
GLPG1205 is an anti-inflammatory small molecule that specifically inhibits GPR84, a protein that promotes chronic inflammation in IPF.
Still recruiting patients, the 26-week, multicenter Phase 2 trial (NCT03725852), called PINTA, is being conducted in Slovakia, and will include up to 60 IPF patients who will randomly receive either 100 mg of GLPG1205 orally or a placebo. During the trial, patients will be allowed to continue treatment with their standard-of-care background therapy, namely Esbriet (pirfenidone) and Ofev (nintedanib).
Lung function will be assessed through spirometry as the total amount of air exhaled, or forced vital capacity (FVC), before and after treatment. Changes in FVC will determine the efficacy of the treatment. Adverse effects of the treatment will be monitored throughout the study.
In addition, improvements in the patients’ functional capacity will be evaluated using the six-minute walk test, and quality of life will be measured with the St. George’s Respiratory Questionnaire.
According to Galapagos, GLPG1205 has shown the ability to alleviate IPF symptoms in preclinical animal models. Furthermore, in a Phase 1 study (NCT01887106) that tested single and multiple doses of the therapy, GLPG1205 was found to be well-tolerated and proved to be safe in healthy volunteers. These studies guided the design of the PINTA trial.
“The first patient dosing in our PINTA Phase 2 trial shows the progress we are making in expanding our IPF franchise,” Piet Wigerinck, PhD, chief scientific officer at Galapagos, said in a press release. “We are strongly committed to the rapid development of our fully proprietary IPF portfolio to address this important unmet medical need.”
In addition to GLPG1205, Galapagos has two other investigational candidates for IPF treatment. GLPG1690 is an anti-inflammatory molecule that inhibits the enzyme autotoxin responsible for tissue scarring or fibrosis. The Phase 3 ISABELA (NCT03711162) trial testing GLPG1690 in IPF patients is ongoing and also continuing to recruit up to 750 patients.
The other candidate, GLPG3499, is in the preclinical stages of development. The mechanism of action of GLPG3499 has not been disclosed yet, but preclinical data in a mouse model for IPF showed that the therapy could effectively reduce IPF signs and symptoms.