Promising Idiopathic Pulmonary Fibrosis (IPF) drug TLB001 moves into Phase 1 Clinical Trial

Prof Alastair Stewart, Department of Biochemistry & Pharmacology, and his team move a step closer to delivering a more effective treatment for IPF, with anti-fibrotic drug TLB001 receiving approval from The Alfred Hospital Ethics Committee to move into Phase 1 Clinical Trials in Australia.

This milestone marks an advance in our team’s efforts to translate many years of foundational work into new and more effective treatments for IPF. -- Prof Alastair Stewart.

Idiopathic pulmonary fibrosis (IPF) is a serious chronic disease that affects the tissue surrounding the air sacs, or alveoli, in the lungs. The condition develops when that lung tissue becomes thick and stiff for unknown reasons. Over time, these changes can cause permanent scarring in the lungs, called fibrosis, that makes it progressively more difficult for IPF patients to breathe, and can mean that not enough oxygen enters your bloodstream.

IPF is a rare disease affecting approximately 9,000 Australians.

Symptoms can be very mild early in the disease, which can make it difficult to detect, and this leads to a delayed diagnosis. IPF is typically fatal within 3-5 years of diagnosis.

In Australia, there are 2,170 new cases of IPF each year.

Idiopathic refers to ‘no known cause’, however it affects people of any age, IPF typically affects older people and is more common in men than women.

The currently approved drug treatments only slow disease progression and have significant adverse effects.

The new treatment, TLB001, leverages proprietary small molecule inhibitors of casein kinase. This is a new drug class initially being developed by Tianli Biotech as an inhalational treatment for IPF.

The research and development program is led by Prof Alastair Stewart, Director of the ARC Centre for Personalised Therapuetics Technologies, Department of Biochemistry and Pharmacology, as Principal Investigator, with medicinal chemistry support being provided by co-Principal Investigator Prof Spencer Williams from the School of Chemistry.

Healthy volunteers will inhale TLB001 aerosol, allowing the drug to directly reach the target lung tissue. The adverse effects which often limit the tolerability of anti-fibrotic drugs given in tablet form are likely to be minimised in this inhaled medicine.

This first-in-human study for TLB001, is set to commence in August, at the Nucleus Network Clinical trial site at the Alfred Hospital site, and is designed to assess the safety, tolerability, and pharmacokinetics of single and repeat doses of TLB001 administered via inhalation to healthy volunteers.

This research is being undertaken via TianLi Biotech, a joint venture between the University of Melbourne and Beijing No.1 Biotechnology Group Co., Ltd.

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