Galecto Biotech Initiates Clinical Phase I/IIa trial in IPF

October 9, 2014

Galecto Biotech AB today announced that dosing in a phase I/IIa trial of TD139 has been initiated. The first in man study, which includes both healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), is aimed at characterizing the safety, tolerability and efficacy of TD139. TD139 is an inhaled inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, including the lung.

“We are very excited to see the successful dosing in this clinical trial”, says CEO Hans Schambye, MD PhD. “We believe TD139 has the capacity to transform the treatment of IPF patients, so this is an important step forward not only for Galecto Biotech but also for patients suffering from this terrible disease”

The phase I/IIa trial is a randomized, double blind, placebo controlled, multi-centre study performed in the United Kingdom. The primary endpoint is the safety and tolerability of TD139, but secondary endpoints include pharmacodynamic efficacy markers, such that the anti-fibrotic effect of TD139 can be assessed.

Chairman of the Board, Magnus Persson continues, ”Galecto was founded in late 2011, so it is a great achievement to start dosing with our lead compound already now. The team has done a magnificent job. Our preclinical studies have demonstrated that TD139 is a very effective treatment of fibrosis – but importantly, it is also a safe and well tolerated compound.”

Since its founding in 2011, the company’s team of scientists and experts has proven that galectin-3 is an attractive drug target and that TD139 is effective in reducing fibrosis in several different organs in animal models.

About IPF
IPF (Idiopathic Pulmonary Fibrosis) is a progressive, irreversible, ultimately fatal lung disease characterized by restriction in lung capacity, due to scarring of the lung tissue. IPF is an orphan indication that affects between 200,000 and 300,000 in the Western world. Currently, only limited treatment options are available, so IPF remains a very substantial unmet medical need.

About Galectin-3
Galectin-3 is a member of the galectin family of galactoside binding lectins. Galectin-3 exists both intra- and extracellularly and binds to glycosylated proteins. Galectin-3 has been shown to play a central role in fibrosis development and progression. The activation of macrophages and recruitment and activation of myofibroblasts – the two central cell types in organ fibrosis – is dependent on galectin-3. Abolition of galectin-3 expression in knock-out animals or pharmacological blockade using Galecto Biotech’s inhibitors lead to dramatic reduction or even prevention of fibrosis.

About TD139
TD139 is a highly potent, specific inhibitor of the galactoside-binding pocket of galectin-3. TD139 is formulated for inhalation, which enables direct targeting the fibrotic tissue in the lungs, while minimizing systemic exposure. TD139 was initially developed by a team of scientists from Lund University, Sweden, and Edinburgh University, the UK.

About Galecto Biotech AB
Galecto Biotech is focused on developing novel drugs for the treatment of fibrosis, inflammation and other serious human diseases. The company’s products target galectins or galactoside binding lectins, which are a group of proteins shown to be involved in many disease processes. Galecto Biotech’s high potency Galectin Modulators may open new treatment possibilities for many patients. The company is led by top-level scientists and biotech executives. Galecto Biotech is located in Copenhagen, Denmark, with close proximity to the founders’ research groups.

For more information, please visit www.galecto.com or contact:
Hans Schambye
CEO, Galecto Biotech
Info[at]galecto.com
Tel: +45 70 70 52 10