Funds raised — totaling $64 million — will be used by the company to prepare for the potential approval of GB0139 in Europe, and to support new clinical trials of investigational therapies.
“Together with our existing cash balance, this raise will enable the continuing development of Galecto, including advancing our promising GB0139 product candidate … towards market,” Hans Schambye, CEO of Galecto, said in a press release.
“This financing will also support the further expansion of our clinical development as we aim to have three Phase 2 studies running by the end of 2020,” Schambye added.
GB0139 is an inhaled small molecule that inhibits galectin-3, a protein that plays a central role in the fibrosis (scarring) of the lungs and other organs, and found at high levels in people with IPF. The potential treatment was recently named an orphan drug in both the U.S. and the EU.
This trial aims to enroll about 450 patients, who will be randomly assigned to GB0139 at one of two doses — 3 mg or 10 mg — or to a placebo once a day for 52 weeks. Its main goal is to evaluate the effects of treatment on forced vital capacity (FVC), a measurement of lung function.
GALACTIC-1 is enrolling eligible adults at sites in the U.S., EU, the U.K., Israel, and Canada. Information is available here.
A previous Phase 2a trial (NCT02257177) in 24 IPF patients reported that GB0139’s used reduced, in a dose-dependent manner, blood levels of YKL-40, a biomarker associated with fibrosis, inflammation, and tissue remodeling.
In addition to GB0139, Galecto is planning to begin Phase 2 clinical trials for two other investigational compounds: GB1211, a galectin-3 inhibitor being developed for liver fibrosis related to non-alcoholic steatohepatitis, and GB2064, an investigational therapy for myelofibrosis (a fibrosis-related blood cancer) that works by inhibiting the fibrosis-associated protein LOXL2.
“We are encouraged by Galecto’s pipeline targeting severe fibrotic diseases, including IPF, and the data generated to date including early signs of GB0139’s potential clinical activity in IPF patients,” Guy Levy, managing member of Soleus Capital, said.
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