Natural killer T-cell therapy to be tested in IPF patients in UK study

UK regulators green light GRI Bio biomarker study of oral medicine GRI-0621

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by Steve Bryson, PhD |

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GRI Bio has been given the green light to begin a Phase 2a clinical trial testing its lead program candidate GRI-0621, a natural killer T-cell (NKT)-targeted therapy, in people with idiopathic pulmonary fibrosis (IPF) in the U.K.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) cleared the launch of the multicenter, two-arm biomarker study, which is expected to enroll about 36 IPF patients.

“We are pleased to receive authorization from the MHRA and take a step in the global expansion of our clinical development for GRI-0621,” Marc Hertz, PhD, CEO of GRI Bio, said in a company press release.

The Phase 2a trial already was ongoing in the U.S. after receiving approval from the U.S. Food and Drug Administration late last year. Interim data from the study is expected by June, with top-line data anticipated by the end of the year.

“We continue to make encouraging progress in the U.S. with our Phase 2a study and believe the approval for this expansion into the UK underscores the global significant unmet need for an IPF treatment option,” Hertz said.

“We are focused on driving this program forward and generating important data readouts this year,” Hertz added.

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Trial to assess safety, tolerability of T-cell therapy against a placebo

IPF is a chronic progressive pulmonary disease of unknown cause marked by abnormal scarring or fibrosis of lung tissue, which leads to symptoms such as cough and shortness of breath.

NKT immune cells, particularly a subset called type 1 invariant NKT (iNKT) cells, have been shown to trigger cellular processes that drive fibrosis and inflammation in IPF.

GRI-0621, given as a once-daily oral capsule, is a small molecule that suppresses the activity of iNKT cells. According to Hertz, the treatment “interrupts disease progressing and restores homeostasis [balance] in the immune system earlier in the inflammatory cascade.”

Participants in the Phase 2a trial will be randomly assigned to either 4.5 mg of GRI-0621 or a placebo, taken once daily for 12 weeks or about three months.

The study’s primary goal is to assess the safety and tolerability of GRI-0621, as indicated by lab tests, vital signs, and side effects after the 12 weeks.

Secondary measures to be assessed at weeks six and 12 include changes in lung function, as well as the impact of GRI-0621 on biomarkers and the activity of iNKT cells in blood samples.

At week 12, as many as 12 participants will have iNKT cell number and activity measured in bronchoalveolar lavage (BAL) fluid — a portion of fluid introduced into the lungs during a bronchoscopy that is then collected for examination.

The therapy candidate’s pharmacokinetics, or its movement into, through, and out of the body, also will be assessed at 12 weeks.

This approval is an important step in the continuum of GRI-0621’s clinical development plan and will help … with the ultimate goal of giving patients with IPF continued access to novel and potentially life-changing medications.

An interim analysis is set to be conducted after the first 24 patients — including approximately eight on the placebo — have completed six weeks of treatment.

Patient enrollment in the U.K. for the T-cell therapy trial is being supported through a collaboration with the National Institute for Health and Care Research Respiratory Translational Research Collaboration (NIHR Respiratory TRC), according to GRI Bio.

“This approval is an important step in the continuum of GRI-0621’s clinical development plan and will help provide the foundation for the continued collaboration between GRI Bio and the NIHR Respiratory TRC with the ultimate goal of giving patients with IPF continued access to novel and potentially life-changing medications,” said Nikhil Hirani, MD, PhD, deanery of the Clinical Sciences Center for Inflammation Research Edinburgh Imaging, in the U.K.