GALACTIC-1 Trial of Inhaled IPF Therapy Hits Enrollment Target

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by Margarida Maia PhD |

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GALACTIC-1

Less than 14 months after stopping its GALACTIC-1 study for certain patients due to safety concerns, Galecto has hit its enrollment target for the Phase 2b trial — now under a revised protocol — testing its investigational inhaled therapy GB0139 for idiopathic pulmonary fibrosis (IPF).

Galecto had resumed trial enrollment for GALACTIC-1 (NCT03832946) — and begun recruiting additional participants — in July 2021 after submitting revised protocols to regulators.

The company in March 2021 had been advised to stop enrolling and treating certain patients due to discrepancies in safety data. Now, Galecto says it remains on track to deliver top-line data on GB0139 by mid-2023.

“We are very excited to complete enrollment in this Phase 2b trial in IPF and are encouraged by the support of the clinical investigators and patients participating in the trial,” Hans Schambye, MD, PhD, president and CEO of Galecto, said in a press release.

GB0139 is a small molecule designed to block galectin-3, a protein that plays a key role in fibrosis, or scarring, of the lungs and other organs. The protein is found at high levels in patients with IPF, and is linked to disease severity, progression, and acute exacerbations.

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“Limited treatment options for patients with IPF make it an area of significant unmet need and patients would benefit from innovative and disease-modifying treatment options that are safe and well-tolerated,” Schambye said.

“Once-daily inhaled GB0139 offers the potential to play an important role in filling this unmet need with its demonstrated ability to specifically target galectin-3, one of the key regulators in the disease. We look forward to topline data from this study in mid-2023,” Schambye added.

The goal of GALACTIC-1 (NCT03832946) is to evaluate how safe GB0139 is, and how well it works versus a placebo in patients with IPF. The therapy is given once daily through a generic dry powder inhaler.

Patients who enter the trial are randomly assigned to receive either 3 mg of GB0139 or a placebo for 52 weeks (one year). The trial is determining the annual rate of decline in forced vital capacity (FVC), a lung function that measures the total amount of air a person is able to exhale after a deep breath.

“The 52-week duration and the centralized read of the primary endpoint [or goal of] forced vital capacity (FVC) makes GALACTIC-1 a significant development for the treatment of IPF,” said Bertil Lindmark, MD, PhD, chief medical officer of Galecto.

Previous studies in mice and patients with IPF had shown that inhaled GB0139 is able to reduce lung scarring. In a Phase 2a trial (NCT02257177), the therapy was generally well-tolerated and led to a reduction in a range of blood biomarkers that have been linked to IPF severity, progression, and mortality.

“If our preclinical data and clinical biomarker data translate to breaking the fall in lung function in IPF, GB0139 may become an important addition to the therapeutic arsenal, in IPF,” Lindmark added.

Inhaled GB0139 has received orphan drug designation in both the U.S. and Europe, and GALACTIC-1 is underway in more than 100 locations across the globe.