CSL commits to new Phase I clinical trials in Australia

"Translating basic medical research to a therapy ready for the marketplace can be a real challenge for our scientific community. To move one product from the early concept stage into a Phase I clinical trial is an important milestone. We are very pleased to move three projects into clinical trials over a 12-month period, all of which will be conducted in Australia. This decision speaks to the dedication of our scientists and the commitment CSL has to bringing new products to patients with unmet medical needs," said CSL Chief Scientific Officer, Dr Andrew Cuthbertson.

CSL's decision to undertake Phase I, first-in-human clinical trials in Australia is supported by a local network of world-class clinical researchers who have the skills to collaborate on early-stage trials. In addition, Australia has a regulatory environment that is supportive of early stage clinical development programs, and accessible Phase I clinical trial infrastructure.

Three New Monoclonal Antibodies

All three therapies are monoclonal antibodies with novel mechanisms of action. Each addresses important areas of unmet medical need and has the potential for multiple indications. The Phase I clinical trials will focus on proof of biological concept with a view to unlocking the full potential of these research assets.

CSL324 is an anti-GCSFR monoclonal antibody, which could be used to treat rare inflammatory diseases caused by overactive neutrophil (white blood cell) activity. CSL324 works by regulating white blood cell activity in autoimmune disease to prevent over-active neutrophils from destroying healthy tissue. The therapy may present a new treatment option for inflammatory diseases involving, for example, skin, joints and lungs. Inflammatory diseases can be debilitating and have serious quality-of-life consequences for the individuals affected. The trial will explore proof of biological concept with particular focus on identifying effective therapeutic dosing.

CSL312 is an anti-factor XIIa monoclonal antibody that is being studied for multiple indications, including Hereditary Angioedema (HAE) – a disorder that causes episodic, sometimes life-threatening attacks of swelling that can affect the face, extremities, gastrointestinal tract and upper airways. For these patients, CSL312 could reduce the frequency of dosing, with the possibility of subcutaneous administration once every two to three weeks instead of bi-weekly dosing. Other potential applications being investigated are the prevention of thrombosis – the process of blood clot formation - particularly on artificial surfaces such as cardiac implants.

CSL346 is an anti-VEGF-B monoclonal antibody that could be used to control glucose absorption in insulin-resistant patients with Type 2 diabetes, by targeting fatty acid metabolism. Type 2 diabetes is one of the fastest growing chronic diseases, affecting more than 420 million1 people globally. CSL346 may also be beneficial for diabetic nephropathy; one of the most common kidney complications associated with Type 2 diabetes.

The three therapies will be showcased today at CSL's R&D investor briefing in Sydney, and form part of a strong pipeline of prospective therapies in various stages of development.