Branching Out in the Area of Genetic Neurology: Collaborating with Australian Clinical Trial Experts

“Similar to oncology, genetics is about to transform the field of CNS diseases.”

In this webinar, attendees will learn about the growing field of genetic neurology, with a focus on therapeutic discoveries, innovations in Phase I trials and leveraging the expertise of Australian-based experts and clinical trial providers.

Inspired by breakthroughs in the genetics of epilepsy, Massachusetts-based Praxis Precision Medicines is focused on both rare genetic epilepsies and more common central nervous system (CNS) disorders. To bring their innovations through the first phase of discovery and validation, Praxis sought the expertise of Australia’s largest Phase 1 clinical provider, Nucleus Network.

The discovery of gene variants that cause epilepsy has been led by a group of world-class academic researchers in Melbourne, Australia. It was this hotbed of epilepsy and genetics leaders that first attracted Praxis to Melbourne. However, when the company began to explore where to conduct their initial Phase 1 studies, they were grateful to find Nucleus Network in the same city, with just the right expertise and capabilities. Moreover, with a population of over 5 million, Melbourne has been an ideal location for Praxis’ studies. According to Praxis Senior Medical Director, Dr. Gabi Belfort, Nucleus Network offered an excellent solution for even highly technical studies involving the monitoring of brain waves by electroencephalography (EEG).

One critical study that was conducted at Nucleus involved measuring the pharmacodynamic effect (on EEG) of one of Praxis’ lead molecules in a multiple ascending dose study. The data collected in this study facilitated dose selection for a subsequent trial in patients with a psychiatric disease. Following on from the success of these initial trials, Praxis will be undertaking a titration study with Nucleus Network for another therapeutic, which may be useful for treating epilepsy or movement disorders.

“We keep coming back to Nucleus because of quality, speed and safety,” says Dr. Belfort. “We can get to trial realisation much faster and the quality of data produced is world-class, without any compromise on safety.” He continued to say “Add to this the R&D rebate and the favourable exchange rate, and it’s a compelling case to conduct the bulk of our Phase I trials in Australia.”

Join this free webinar to learn more about the genetics underlying neurological diseases and conducting CNS clinical trials using expert Australian Phase I trial providers like Nucleus Network.

Speakers

Cameron Johnson, CEO, Nucleus Network

Cameron Johnson is considered one of the most experienced Phase I Clinical Trial professionals in Australia, having held senior management roles within three Phase I Australian Clinical Trial companies.

Johnson Phase I experience extends into Europe and the Clinical Research Organization (CRO) industry, where he managed Clinical Trial facilities across Australia and New Zealand. He joined Nucleus Network in September 2013 as Chief Operating Officer before moving into the position of Chief Executive Officer (CEO) in May 2016.

Prior to commencing at Nucleus Network, Johnson was the inaugural CEO at an Australian Phase I Clinical Trials facility interstate. In 2019, Johnson led the acquisition of QPharm in Brisbane and Prism Clinical Research in Minnesota.

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Gabi Belfort, MD, PhD, Senior Medical Director, Praxis Precision Medicines

Dr. Gabi Belfort is a central nervous system (CNS) focused physician-scientist and medical director. With eight years of experience in the industry, Belfort is leveraging the latest advances in neuroscience to advance novel medicines through rigorous clinical trials. His work on neurosteroid GABAA receptor modulators contributed to the recent approval of Zulresso (brexanolone) for the treatment of post-partum depression. Now at Praxis Precision Medicines, Belfort is on a team utilizing the emerging genetic causes of various epilepsies for the creation of precision therapeutics for patients with these conditions. Belfort has conducted two successful studies at Nucleus Network and is working on a third.

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