Midstage results indicated that Galecto’s inhalation treatment for idiopathic pulmonary fibrosis was unsuccessful, putting an abrupt end to the company’s rocky clinical journey developing the drug.
According to a statement released on Tuesday, the company has decided to stop developing GB0139, a small-molecule inhibitor of galectin-3, and will instead focus on developing a therapy for liver cirrhosis, pending a new trial.
When compared to placebo, GB0139 did not change the pace at which patients’ forced vital capacity (FVC) – a measure of how much air they are able to exhale – declined from baseline in the phase 2 trial. As a matter of fact, individuals administered with a 3-mg daily dosage of Galecto’s candidate fared substantially worse than those given placebo, with an average loss in FVC of 316.6 ml compared to a less noticeable decline of 127.5 ml with the placebo.
Galecto also reported an increase in galectin-3 protein levels across both treatment groups, indicating insufficient target engagement. There were a total of 173 participants in the study, all of whom were new to the standard-of-care therapy for IPF, either Esbriet (Genentech) or Ofev (Boehringer Ingelheim).
The findings and accompanying decision to discontinue the trial bring an abrupt conclusion to a challenging clinical journey. Due to an “imbalance” in the occurrence of major adverse effects, the data safety and monitoring board advised in March 2021 that the company discontinue the 10-mg treatment arm.
Because of this, the 3-mg arm became the sole choice, and enrollment was restarted a few months later. However, the newly reported safety profile failed to distinguish, with 7.8% of those being treated reporting significant adverse events, compared to 1.4% of placebo arm participants, and with one severe adverse event in the treatment arm due to the use of the drug.
CEO Hans Schambye remarked, “We clearly saw more side effects in the sort of IPF infection exacerbation with the drug and that’s where we’re searching for the explanation for what’s happening.”
Galecto indicated that fatal adverse events were similar across the treatment and placebo groups, while Schambye said that treated patients had a little reduced mortality rate. The study drug was not responsible for any of the fatalities that occurred in the treatment group.
Galecto is presently focusing on developing its GB1211 galectin-3 inhibitor for the management of liver cirrhosis. In early 2024, the company will begin a placebo-controlled phase 2 study for individuals with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis. This followed a type C conference with the FDA.
Schambye stated that despite other biotechs showing promise in treating NASH early in the disease’s development, he feels the market potential is large because of the dismal outlook for those who develop cirrhosis.
It is clear that Galecto has to raise more money to keep GB1211 alive through the forthcoming research and beyond. Schambye added that investors were being cautious while the IPF medication was the center of attention, considering how hard it is to treat the lung condition. However, the CEO believes that by shifting attention to liver illness, he may attract fresh interest and funding.