Oral therapy GRI-0621 found safe in IPF clinical trial’s interim analysis
Interim data was reviewed from 24 patients treated for six weeks
An experimental oral therapy for idiopathic pulmonary fibrosis (IPF) has been tolerated well in an ongoing Phase 2 clinical trial, according to interim data announced by its developer GRI Bio.
After reviewing interim data from 24 patients treated with GRI-0621 for six weeks, an independent data monitoring committee (IDMC) — outside experts tasked with reviewing findings from the trial to ensure participant safety — has recommended that the Phase 2a study (NCT06331624) continue as planned.
“We are happy to report the IDMC confirmed no safety concerns in the first 24 subjects evaluated after [six] weeks of treatment,” Marc Hertz, PhD, CEO of GRI, said in a company press release.
IPF is a chronic disorder marked by lung fibrosis, or scarring. GRI-0621 is designed to reduce the activity of type 1 invariant natural killer T-cells (iNKTs), an immune cell thought to play a role in driving fibrosis in IPF. The therapy contains a molecule called tazarotene that activates retinoid acid receptors beta and gamma, two proteins that normally reduce iNKT activity.
Results of safety analysis for GRI-0621
The Phase 2a study intends to enroll 36 people with IPF, ages 40-85. Its participants are being randomly assigned 4.5 mg of GRI-0621 or a placebo daily for 12 weeks, the main goal being to evaluate the treatment’s safety. The study may still be enrolling participants in the U.S., Australia, and the U.K.
GRI plans two interim safety analyses. The first was conducted after 12 patients had been treated for two weeks. The results from this second analysis were broadly similar to what was seen in the first analysis, with none of the participants having abnormal levels of cholesterol or other fats and its safety findings consistent overall with studies with other formulations of oral tazarotene.
Hertz said the data “[build] upon the [two]-week safety data reported earlier and [add] to the large safety data available for oral tazarotene.”
The Phase 2a trial is also evaluating how GRI-0621 affects various biomarkers related to IPF disease. The initial two-week analysis indicated the therapy is reducing fibrosis as expected. An interim analysis of six-week biomarker data is ongoing, with results expected this month. Full top-line results should be announced in the third quarter of this year.
“We are encouraged by the consistent safety data and early antifibrotic trends previously reported and remain on track to report [six]-week interim biomarker data in the coming weeks, followed by top-line data expected in the third quarter of this year,” Hertz said.
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