Sector calls for action as pandemic hits clinical trials

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Attention and concern over the impact of COVID-19 may move to Australia's future clinical trial capability and the biotechnology sector.

The federal government has consistently highlighted the importance of medical research to the global effort currently underway on finding a solution to the pandemic. Yet there are growing concerns that without intervention the pandemic could have a very negative impact on one of the pillars of Australia's medical research infrastructure - small to medium size life science companies and clinical trials.

Some global biopharmaceutical companies have confirmed the impact of COVID-19 with delays in clinical trial programs.

AusBiotech, Medicines Australia, and the Medical Technology Association of Australia, recently combined to issue a joint statement in support of clinical trials as the health system prepares to manage the full impact of COVID-19.

Several Australian-based and listed biotechnology companies have already issued announcements detailing the impact of COVID-19 on their clinical trial programs.

Melbourne-based Cynata Therapeutics (ASX:CYP) announced plans to delay its phase two clinical trial program in response to COVID-19. It said the Clinical Trial Support Office of the University of Sydney advised trials should not commence until the impact of the pandemic is resolved.

Another Melbourne-based company, Opthea (ASX:OPT), which is developing treatments for eye disease, said it was "extremely grateful" to have completed patient dosing and all follow-up in a phase two trial of its OPT-302 investigational therapy. 

Opthea is planning for a phase three trial program, including manufacturing, and recently reiterated the strength of its cash position - $70 million - that "provides sufficient runway to focus on corporate strategic objectives and clinical development activities as the COVID-19 situation continues to evolve."

In a statement, AusBiotech CEO Lorrain Chiroiu said, “The biotech sector is being impacted in many and varied ways. While a number of companies have commenced new trials of therapeutics for COVID-19, a number of companies are reporting that they are suspending their clinical trials or recruitment of new patients, while the health system quite rightly responds to the health crisis at hand.

“Access to capital remains an ever-present issue for pre-revenue biotechs and AusBiotech has joined the growing chorus of businesses calling for the Government to fast track R&D Tax Incentive cash refunds, which would be due later in the year.”

“The JobKeeper payments would be a great help, but most biotech SMEs don’t have revenue yet; they have cash burn for prolonged periods. Sadly, the allowance is only available to revenue-making companies. As such, it appears to systematically disadvantage the SMEs in the biotech and medtech sector. These pre-revenue companies house priceless talent and intellectual property that could be permanently lost to Australia if they are not able to weather the COVID-19 storm.”

According to Medicines Australia chief executive Liz de Somer, "The pharmaceutical industry stands side by side with our biotechnology partners in seeking to protect Australia's research sector. As COVID-19 effects small, medium and large companies, the biotech sector is facing specific challenges.

"Clinical trials provide early access to new treatments and are a proven benefit for patients who may have few options left. All companies are seeking to keep existing clinical trials open, where it is safe and viable to do so, so that patients can continue to receive treatments and important research findings are not squandered.

"Additionally, we are looking forward to constructive ways that clinical trials can be sustained, including remote monitoring of patients and telehealth, together with improvements to ethics and governance systems that will encourage continuing foreign investment to Australia.

"Research is a fundamental component of our sector, that may lead to incredible breakthroughs. While the pharmaceutical industry has the potential to withstand much of the challenges being faced at this time, it is imperative that smaller biotech companies, the associated scientific research community, and their support teams can remain resilient and recover quickly to continue to feed the pipeline of medical discovery.

"We must act now in the short term to ensure it survives and flourishes in the long term," added Ms de Somer.