Galecto Biotech’s Lead Molecule TD139 is Safe, Well Tolerated, with Direct Target Engagement and Biomarker Effects in a Clinical Phase Ib/IIa trial in IPF Patients

Copenhagen, March 10, 2017

Today, Galecto Biotech AB can announce the successful completion of its phase Ib/IIa clinical trial of inhaled TD139. The new drug demonstrates ground-breaking results for patients suffering from Idiopathic Pulmonary Fibrosis (IPF), a chronic and severe disease characterized by a progressive decline in lung function.

Successful trial shows unique results
Galecto Biotech has successfully completed its phase Ib/IIa clinical trial of TD139, the biotech company’s new drug developed for patients suffering from Idiopathic Pulmonary Fibrosis.

Twenty-four patients were treated with TD139 or placebo for two weeks. TD139 is an inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, including the lung.

“TD139 has shown ground-breaking results in this proof of concept study in individuals with IPF raising the prospect that this compound could represent an important future therapeutic option for this devastating disease,” says Dr Toby Maher, from the Royal Brompton Hospital and Imperial College in London and chief investigator of the trial.

The phase I/IIa trial was a randomized, double blind, placebo controlled, multi-centre study performed in four centres in the United Kingdom. TD139 was extremely well tolerated in all patients with PK exhibiting proportional systemic exposure with a favourable half-life. Absorption within alveolar macrophages, the target-cell in question, also mirrored systemic exposure.

“Galecto’s IPF trial has resulted in a paradigm shift for studying disease modifying agents for lung disease,” says Dr Nikhil Hirani from the Edinburgh Medical School, and principal investigator in the trial. “By performing bronchoscopies before and after the treatment period, we have been able to detect biomarker changes in plasma and alveolar cells whilst also precisely quantifying the amount of TD139 that has reached the target cell. This has to my knowledge never been done before – neither with a potential IPF treatment nor with an inhaled drug of any kind.”

“We are delighted to see the successful completion of this complex and pivotal clinical trial,” says Doctor Paul Ford, Galecto’s Chief Medical Officer. “Given these unique results they will pave the way for a phase IIb dose ranging study, which can be started in the near future.”

“Galecto has transformed into a clinical stage company with a strong and deep portfolio in the fields of fibrosis, cancer and ophthalmology. Truly very exciting!” says Hans Schambye, MD PhD, and CEO of Galecto.

Detailed results from the IPF trial will be presented at the meeting of the American Thoracic Society in Washington, May 2017.

Background information

About IPF
IPF (Idiopathic Pulmonary Fibrosis) is a progressive, irreversible, ultimately fatal lung disease characterized by restriction in lung capacity, due to scarring of lung tissue. IPF is an orphan indication that affects between 200,000 and 300,000 in the Western world. Currently, only partial treatment options are available, so the future treatment of 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 knockout 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. 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 galectin-3 inhibitors are effective in reducing fibrosis in several different organs in animal models.

Galecto Biotech is funded by Novo Seeds, Merck Ventures, Sunstone Capital and SEED Capital. Galecto Biotech is located in Copenhagen, Denmark, with close proximity to the founders’ research groups.

For more information, visit www.galecto.com

For further information please contact:

Hans Schambye
CEO, Galecto Biotech
info[at]galecto.com
Tel: +45 26 3737 26