Galecto has announced they have completed enrollment in their Phase2b trial which will investigate GB0139 as a treatment for idiopathic pulmonary fibrosis (IPF). This trial is called GALACTIC-1.
Galecto anticipates that by the middle of 2023, they will be able to release results from this investigation.
Previous investigations of this therapy have shown that it is well-tolerated in IPF patients. Importantly, it was able to lower many plasma biomarkers which are linked to severity of IPF, disease progression, and mortality. It also hindered galectin-3 within the lungs.
As scarring in the lungs is irreversible in IPF and can lead to very low levels of lung function, new treatments are drastically needed. Researchers are hopeful about the potential of this new therapy.
This treatment is a small molecule inhibitor of galectin-3. Galectin-3 is a fibrosis cascade regulator.
GB0139 is administered via a dry powder inhaler. It is meant to be dosed once every day.
GALACTIC-1 is a double-blind, placebo-controlled, double-blind trial which will take place at multiple trial centers. In fact, it will include almost 100 different trial sites across the globe. 141 patients have enrolled in this investigation.
All patients in this trail will be randomized (2:1) to receive GB0139 or the placebo. Those given the treatment will be dosed 3mg every day for a total of 52 weeks.
The primary endpoint of this investigation will be the decline of forced vital capacity (FVC) over one year. The FDA has already accepted this measure as a primary endpoint when evaluating the current standard of care therapies in IPF. Safety of the treatment will also be investigated.
Researchers are hopeful about the potential of this therapy. If this trial leads to positive results, GB0139 could become a new therapeutic option for patients diagnosed with IPF.
You can read more about this new investigative treatment here.