GRI Bio meets interim clinical trial enrollment goal for IPF therapy
GRI-0621 now being tested in 24 adults; initial results expected soon
GRI Bio has reached an interim enrollment goal for its Phase 2a clinical trial testing GRI-0621 — a therapy targeting natural killer T-cells (NKT cells) to treat idiopathic pulmonary fibrosis (IPF) — and expects to report initial results later this quarter, per a company press release.
With 24 of an expected 36 participants enrolled, the company said it’s on track to complete a planned analysis of the therapy’s safety and efficacy after six weeks of treatment.
The Phase 2a study (NCT06331624) is still recruiting adults, ages 40 to 85, at sites in the U.S., the U.K., and Australia.
“We are pleased with the progress made in this Phase 2a biomarker study,” said Marc Hertz, PhD, CEO of GRI Bio. “With the patient participation seen in the trial to date, we remain on track to report interim data later this quarter and topline results from this important study in the third quarter of this year,” or by the end of September.
The enrollment milestone follows an announcement from the company early last month that the medication was found to be safe and well-tolerated after two weeks of daily treatment in the first 12 participants evaluated.
“The momentum with enrollment combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need,” Hertz said.
GRI-0621 targets natural killer T-cells to treat IPF
In IPF, scar tissue builds up in the lungs for unknown reasons. This leads to symptoms that typically include cough and shortness of breath.
People with IPF generally have high levels of NKT cells — a component of the immune system — in their lungs, according to GRI Bio’s previous work. Type I invariant NKT (iNKT) cells can trigger the processes that lead to inflammation and tissue scarring, medically known as fibrosis, making them a possible therapeutic target for IPF.
GRI-0621 is a small molecule, taken orally in capsule form, that inhibits iNKT cell activity. It does so by activating retinoid acid receptors beta and gamma, which normally work to suppress the activity of iNKT cells.
The ongoing Phase 2a trial is comparing the safety and efficacy of a 4.5 mg daily dose of GRI-0621 to a placebo in adults with IPF. In the trial, participants are randomly assigned to receive GRI-0621 or placebo for 12 weeks, or about three months.
The momentum with enrollment combined with our recently announced interim safety results, bolsters our confidence in the potential of GRI-0621 to provide a much needed treatment option for the treatment of IPF, where there remains significant unmet need.
GRI Bio planned for two interim analyses of the data: one conducted after the first 12 participants completed two weeks of treatment, and another carried out once 24 participants completed six weeks on the therapy.
The results from the two-week analysis that focused on safety showed that patients tolerated the therapy well. None developed hyperlipidemia, or an excess of fatty molecules in the blood, and the therapy’s toxicity profile was similar to that of tazarotene, which binds to the same types of receptors as GRI-0621.
Additional biomarker data from the first 12 patients evaluated also backed GRI-0621’s antifibrotic effects, which prompted an independent data monitoring committee to recommend the trial to continue as planned.
After the 24 enrolled participants complete six weeks of treatment, GRI Bio intends to release its next round of interim results. The company plans to further analyze the therapy’s safety and begin to assess its pharmacokinetics, or the way the medication moves into, through, and out of the body. Researchers also will examine iNKT activation in the blood and explore how the medication affects lung function.
“We are grateful for the dedicated work and participation of our clinical staff, patients and families in this trial,” Hertz said. “Our team is working to bring enrollment to its completion.”
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