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May 22, 2020

Galecto IPF Phase IIb trial goes full steam ahead

By GlobalData Healthcare

On May 6, Galecto announced that it had recruited more than 150 patients to date for its Phase IIb GALACTIC-1 study of GB0139 (formerly TD139) for idiopathic pulmonary fibrosis (IPF). GP0139 is an inhaled galectin-3 inhibitor.

The company stated that its ability to recruit, especially in areas that have been most affected by Covid-19, namely Belgium, Italy, the UK, and France, demonstrates that pulmonologists are eager to evaluate the potential benefits for their patients.

The company anticipates that despite the ongoing global pandemic, clinical milestones for this trial remain unchanged and data readout is expected in 2022. Once approved, GP0139 would be the first inhaled therapy available for IPF patients.

The Covid-19 pandemic has amplified the logistical challenges that normally face a company conducting clinical research. Galecto’s ability to continue with its timeline is admirable, as many IPF trials have had on average a two-month delay in primary completion dates.

Recently, Fibrogen announced that it would be pausing enrollment of its Phase III ZEPHYRUS trial studying pamrevlumab for IPF patients. It is possible that data readouts may continue to be pushed back even further as many cities and countries struggle with how and when to re-open.

Being able to forge ahead with treatment at this time represents a major victory for Galecto. KOLs interviewed by GlobalData said that many IPF patients are eager to proceed with studies and continue treatment for their condition. However, the decisions about whether to continue patient monitoring ultimately lie with the individual sponsors.

Galecto is the only IPF developer thus far to announce continued recruitment for its late-stage studies. Additionally, GALACTIC-1 is currently the largest ongoing Phase II study being conducted in IPF, which could serve as an advantage in recruiting patients into its potential Phase III study due to the robustness of the study if positive results are attained, particularly as several Phase III trials are expected to run at the same time, for example BMS/Celgene’s CC-90001 and Liminal’s PBI-4050 programs.

GlobalData anticipates that GP0139 will launch in late 2026 in the US, approximately three years after the launch of current front-runner Galapagos’ IPF drug, GPLG1690.

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