Galecto has axed the development of its lead pipeline candidate, GB0139, after announcing that the Phase IIb trial for the drug failed to meet the primary endpoint in patients with idiopathic pulmonary fibrosis.
The news decimated Galecto’s stock price, with the stock down over 71% at the market close on 15 August, compared to the market close on the previous day.
Galecto put on a brave face with its CEO stating, “As of 31 July, 2023, Galecto had approximately $49m in cash, cash equivalents and investments. Given the impact of the results from the GALACTIC-1 trial on our future plans, we are currently evaluating resource allocation with the goal of extending our cash runway into 2025.”
The placebo-controlled Phase IIb GALACTIC-1 trial (NCT03832946) had a lot of momentum, with the trial having no issues in patient recruitment even during the Covid-19 pandemic. However, all of this was for nought as the trial failed to show a change in the rate of decline of forced vital capacity, a measure of lung function, from baseline at 52 weeks.
Reported treatment-related serious adverse events, including worsening of disease, were seen in 7.8% and 1.4% of the patients in the treatment and placebo groups, respectively. The detailed results of the trial are planned for presentation at a future medical conference.
Galecto pipeline updates
Following a Type C meeting with the US Food and Drug Administration (FDA), a placebo-controlled Phase IIa trial to evaluate the safety and efficacy of GB1211, an oral galectin-3 inhibitor for the treatment of patients with decompensated non-alcoholic steatohepatitis (NASH) cirrhosis, is planned to begin in early 2024. Though, the trial initiation is contingent on Galecto obtaining additional funding for the trial.
GB1211 is also being evaluated as a combination therapy with Roche’s Tecentriq (atezolizumab) for non-small cell lung cancer (NSCLC) in an open-label Phase II trial (NCT05240131).
The topline results from the open-label Phase IIa trial for GB2064 (NCT04679870) in myelofibrosis (a rare blood cancer) are expected in late 2023.
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