FDA approves an IND from Galecto Biotech for TD139 treatment of IPF patients. – Phase Ib/IIa Trial to Start in the UK

Copenhagen, March 1, 2015

Galecto Biotech AB today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for the company’s galectin-3 inhibitor, TD139, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Simultaneously, the company announced that a phase Ib/IIa trial in IPF patients is due to start shortly in several centers in the United Kingdom (UK).

“We are very excited to receive approval for our clinical trial in patients from both the FDA and the MHRA, the UK regulatory authorities”, says CEO Hans Schambye, MD PhD. “This validates the work performed so far and allows us to move quickly towards demonstration of the safety and efficacy of TD139 in IPF patients.

TD139 is an inhalable galectin-3 inhibitor, which has been shown to effectively reduce fibrosis in several preclinical studies.

Recently, a phase I study of TD139 in healthy volunteers was successfully completed. “Our phase I study demonstrated that TD139 is safe, tolerable and highly suitable for dosing in IPF patients”, says Dr. Paul Ford, Chief Medical Officer at Galecto. “”We look forward to working with leading clinics in the UK in the phase Ib/IIa trial. This is an important step forward for patients suffering from this terrible disease.”

The phase Ib/IIa trial is a randomized, double blind, placebo controlled, multi-centre study performed in England and Scotland. 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.

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 funded by Novo Seeds, MS Ventures (the strategic, corporate venture arm of the biopharmaceutical division of Merck KGaA, Darmstadt, Germany), Sunstone Capital and SEED Capital. Galecto Biotech is located in Copenhagen, Denmark, with close proximity to the founders’ research groups.

In November, 2014, Galecto Biotech announced that it has entered into an option agreement with Bristol-Myers Squibb for a total potential payment of $444 million.

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