Galecto Biotech is planning a new international Phase 2/3 clinical trial to evaluate inhaled TD139, its investigational candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
The design of the study, which will be conducted at several clinical centers across Europe and North America, has already been agreed upon with the U.S. Food and Drug Administration and U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), Galecto Biotech CEO Hans Schambye said in a press release.
The Denmark-based company recently raised a total of €79 million (approximately $90 million) from several investors in a series C funding round. This funding will be used to launch TD139’s Phase 2/3 trial in IPF, as well as to explore other candidates for the treatment of fibrotic diseases affecting other organs, such as the liver and eye.
“We welcome and thank our new and existing investors for their commitment to advancing our galectin modulator products to late-stage clinical development,” Schambye said. “The closing of this €79 million financing is a significant milestone for Galecto as it allows us to quickly take TD139 into the Phase 2/3 study.
“The financing will also enable clinical studies for two additional programs, which are based on galectin modulators optimized for dosing in fibrotic diseases of other organs.”
TD139 is a highly potent and specific inhibitor of the enzyme galectin-3, which is known to play a central role in the development and progression of fibrosis. By preventing galectin-3 activity, TD139 reduces the recruitment and activation of immune cells responsible for the fibrotic process.
Previous results from a randomized Phase 1/2a trial (NCT02257177) in 36 healthy volunteers and 24 IPF patients demonstrated that inhaled TD139 is safe and well-tolerated, directly targeting fibrotic tissue in the lungs while minimizing systemic toxicity.
Early efficacy data revealed that IPF patients who received TD139 for two weeks had reduced levels of molecules known to cause lung fibrosis, compared with those who were treated with a placebo. This finding suggests that inhaled TD139 may have potential to prevent fibrosis and help slow IPF progression.
“The data generated to date suggests that Galecto’s TD139 has a highly competitive profile in IPF due to its good safety profile and inhaled dosing, providing a clear path to market,” said Karen Wagner, general partner of Ysios Capital, which, along with OrbiMed, was the principal investor of the series C funding round launched by Galecto.
“We were attracted to Galecto by the excellent science, great promise for its lead inhaled product in IPF as well as the galectin inhibitor technology platform, which is generating multiple drug candidates,” said Chau Khuong, a partner at OrbiMed.