Enrollment Resumes in GALACTIC-1 Trial of Inhaled Therapy GB0139
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Enrollment has resumed, under a revised trial protocol, in the Phase 2b study GALACTIC-1, which is evaluating Galecto’s investigational inhaled therapy GB0139 in adults with idiopathic pulmonary fibrosis (IPF).
Galecto in March had been advised to stop recruiting and treating certain trial participants after disparities were found in a safety review.
All treatments with the higher 10 mg dose of GB0139 were halted, as were those with the lower 3 mg dose given in combination with other IPF standard-of-care therapies, such as Esbriet (pirfenidone) and Ofev (nintedanib).
The stop recommendation came from an independent data safety and monitoring board (DSMB), which had conducted a review of GALACTIC-1 (NCT03832946) data. That safety review revealed a disparity in serious adverse events seen across study groups.
Based on those findings, the DSMB recommended that participants in both groups stop treatment and leave the study.
Following the DSMB’s recommendation, a total of 38 patients continued receiving treatment as part of the trial.
Now, Galecto is recruiting additional participants — up to 210 — under a revised protocol submitted to the U.S. Food and Drug Administration (FDA) and other regulatory bodies, including those in the U.K., Australia, Spain, and Germany.
Newly recruited participants include patients who are not taking Esbriet or Ofev, and will be randomly assigned to receive either 3 mg of GB0139 or a placebo.
“We believe the 3 mg dose of GB0139, as a single agent, has the potential to be an effective and potentially life-changing treatment,” Hans Schambye, MD, PhD, Galecto’s CEO, said in a press release.
“We are pleased to continue our Phase 2b GALACTIC-1 trial of GB0139 in IPF patients,” Schambye added.
GB0139 is designed to block the protein galectin-3, which is a known driver of tissue inflammation and scarring (fibrosis).
A previous Phase 2a trial (NCT02257177) in patients with IPF demonstrated that GB0139 safely and significantly lowered the levels of galectin-3 found in lung macrophages — immune cells known to contribute to inflammation and fibrosis in IPF — along with several IPF biomarkers.
“In our previous study of GB0139 in IPF patients, we showed that the 3 mg dose is well-tolerated and easy to administer for the patients,” Schambye said. “We observed target engagement at that dose level, with a decrease in lung macrophage Galectin-3 levels, as well as reduction in a number of fibrosis biomarkers, including YKL-40, PDGF, and PAI-1.”
GALACTIC-1 is a 52-week (one-year-long) trial being conducted at more than 100 sites worldwide. Its goal is to evaluate the efficacy and safety of GB0139 in IPF patients, ages 40 and older.
The new trial protocol will retain the same statistical power needed to assess the primary outcome of a decline in forced vital capacity or FVC. That parameter measures the total amount of air expelled after a deep breath and is a key measure of lung function.
In addition to safety, secondary outcomes include assessing the proportion of participants whose FVC declines by more than 10% following treatment, as well as the time to hospitalization or mortality.
Galecto anticipates top-line data from GALACTIC-1 to become available by mid-2023.
Regulatory agencies in Europe and the U.S. have granted GB0139 orphan drug status to support its clinical development and review.
“Around 50% of IPF patients in Europe and the US do not receive treatment with either [Esbriet] or [Ofev], representing a significant unmet medical need,” Schambye said. “We are confident in the safety of the 3 mg GB0139 dose based on our previous clinical results and the blinded data in the GALACTIC-1 trial.”
“We are looking forward to continuing to investigate this exciting drug candidate,” he added.
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