The results came from a Phase 1b/2a clinical trial (NCT02257177) evaluating TD139 in two parts. Phase 1b was a randomized, double-blind, placebo-controlled, single-ascending dose trial that evaluated the safety, tolerability, pharmacokinetics (how a drug behaves) and pharmacodynamics (how the body reacts to a drug) of TD139 in 36 healthy men.
Phase 2a was a randomized, double-blind, placebo-controlled, multiple dose expansion trial that evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of TD139 in 24 IPF patients.
The findings revealed promising signs that TD139 may help to slow disease progression. After two weeks, those treated with the drug had reduced blood levels of key molecules known to be linked to a worsening of the disease.
TD139 was also found to be well tolerated by all patients without causing serious side effects.
“This is a welcome and much needed breakthrough for the treatment of IPF. This inhaled drug is delivered directly into the lung, is concentrated within lung cells and has minimal side effects in the short term,” Nikhil Hirani, a researcher with the MRC Centre for Inflammation Research at the University of Edinburgh, said in a news release.
The trial was led by the University of Edinburgh in collaboration with scientists from Lund University in Sweden.
Researchers will now evaluate TD139 in a larger IPF clinical study to determine the optimal dose providing clinical benefits.
TD139 is an inhibitor of galectin-3, a protein known to play a key role in fibrosis development in several organs, including the lungs.
“Galectin-3 is also involved in the scarring process in other organs of the body. This research opens up new potential to develop other galectin-3 blockers to treat fibrotic conditions of the heart, liver and kidneys.” said Alison Mackinnon, from the MRC Centre for Inflammation Research.
Galecto presented detailed results of the trial at the American Thoracic Society (ATS 2017) meeting May 21 in Washington, D.C.
IPF is a disease of unknown cause in which tissue deep in the lungs becomes thick and stiff, or scarred, over time. The formation of scar tissue is called fibrosis. As the lung tissue thickens, lungs can’t properly transfer oxygen into the bloodstream; as a result, the brain and other organs don’t get the oxygen they need.
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