Clinical trials affected by COVID-19 pandemic

Thu April, 16th 2020

Clinical trials of new drugs to treat Huntington’s disease that are taking place in Australia have been affected by the COVID-19 outbreak.

The pandemic has diverted many staff into frontline healthcare and will impact on the three trials being conducted by biotech companies Roche and Wave Life Sciences.

Doctors and trial site staff are following the advice of the companies sponsoring the trials. They also must abide by the requirements of the states and hospitals where the trials are taking place to minimise the risk of exposure to the virus for trial participants and staff.

The companies involved remain committed to completing the trials which involve people who are showing symptoms of HD in Australia and across the world.

Huntington’s Victoria CEO Tammy Gardner said changes in the trial activities vary from site to site in Australia and all participants will have been informed of these changes by the site teams.

“This is a difficult time for everyone but these decisions are being made with the health and safety of all those involved in mind,” she said.

“We have been informed that the changes may include the temporary suspensions of visits by trial participants or changes in the frequency of visits.

“Anyone who is participating in a trial should keep in contact with the site team if there are questions they have or information they need.

“We have also been assured those trial site doctors and staff will closely monitor the health and safety of all participants.”

Focus of the trials

The three trials involve DNA-based drugs which are designed to target the underlying cause of the disease by lowering the levels of the mutant huntingtin protein. That protein is believed to cause the damage to the brain that people with HD suffer.

Wave Life Sciences is testing two drugs in the PRECISION-HD1 and PRECISION-HD2 Phase 1b/2a trials.

Roche is conducting a phase 3 trial called Generation HD1 to test a promising drug now called Tominersen.

That trial began last year and was expanded in October from 660 participants with HD to 801. It is due to be completed in 2022.

Huntington’s Victoria has been told by researchers that all three trials have so far been progressing well with the recruitment of volunteers and the testing and treatment they have undertaken.

Both Wave and Roche have clinical trial sites in Melbourne and Sydney hospitals. Wave also has sites in Brisbane and Perth.