Phase 2b clinical trial of IPF candidate GB0139 finishes dosing
Top-line results from GALACTIC-1 due in August
The trial, which finished enrolling participants about a year ago, is testing the safety and effectiveness of the inhaled treatment candidate against a placebo among IPF patients who are not using or couldn’t tolerate standard-of-care therapies. Top-line results are expected in August, according to its developer, Galecto.
“We are pleased to have completed dosing in the GALACTIC-1 trial, which is a component in Galecto’s quest to develop anti-fibrotic drugs,” Hans Schambye, MD, PhD, president and CEO of Galecto, said in a company press release. “We’ve had significant interest in the outcome of the GALACTIC-1 trial and we plan to report top-line data from this study in August 2023.”
Fibrosis, or scarring, of the lungs is the hallmark feature of IPF.
Current standard-of-care anti-fibrotic therapies include Ofev (nintedanib) and Esbriet (pirfenidone). These oral treatments have shown a modest impact on disease progression, but can be accompanied by significant side effects that limit patients’ adherence or require dose reductions, according to Galecto.
GB0139 is an inhaled small molecule inhibitor of galectin-3, a protein involved in fibrosis signaling cascades. Elevations in galectin-3 are observed in fibrotic lung tissue and have been linked to disease severity, progression, and acute symptom worsening.
The experimental therapy was granted orphan drug status in the U.S. and Europe, a designation intended to speed development toward regulatory approval.
“Patients with IPF need new and more tolerable treatment options and we believe GB0139 has the potential to address this significant unmet medical need, while being easy to administer as a once-daily inhaled treatment,” Schambye said.
GALACTIC-1 resumes after pause
GALACTIC-1 (NCT03832946) was launched to evaluate GB0139’s safety and effectiveness in patients at around 100 sites worldwide. Its participants were to be randomly assigned to receive GB0139 (10 mg or 3 mg) or a placebo once a day through a generic dry powder inhaler for a year.
The company was advised by regulatory bodies in March 2021 to pause enrollment and treatment for some patients over safety concerns, however. Those receiving the higher 10 mg dose of GB0139 and those given the 3 mg dose with Esbriet or Ofev stopped treatment and left the study.
Enrollment resumed in July 2021 after Galecto submitted revised protocols to regulators, reaching its target enrollment last May.
All 144 participants now are either not taking or didn’t tolerate Esbriet or Ofev and were randomly assigned to receive GB0139 (3 mg) or a placebo for a year.
The trial’s main goal is to assess the annual rate of decline in forced vital capacity (FVC), a measure of lung function. Changes in FVC were also used as a primary endpoint for previous pivotal trials of Ofev and Esbriet, according to Galecto.
Secondary goals include assessing changes in exercise capacity, other measures of lung function, and quality of life.
Based in Boston, Galecto is a biotechnology company focused on developing new treatments for fibrotic conditions. In the last year, it’s released promising clinical data of its anti-fibrotic candidates for liver cirrhosis and myelofibrosis.