The coronavirus pandemic has battered the smooth running of clinical trials for new drugs worldwide, but Australia has managed to pull through in a comparatively strong position, according to a biotechnology outfit researching an eye treatment.
“Because Australia and New Zealand had done such a great job, with respect to managing the current rates of infection, we’ve been able to revamp our clinical studies and recruit patients without necessarily missing a beat, to a certain degree,” said Sydney-based Azura Ophthalmics chief executive Marc Gleeson.
He said he knew of small clinical research organisations in Australia receiving inbound queries for that same reason.
Clinical trials are key make-or-break events for life-science companies, some of which run on the mantra “speed to market”. But the pandemic’s impact on trials is a phenomenon noted worldwide, with an academic paper in Biomed Central noting many had paused recruitment “due to lack of site research staff and the need to minimise face-to-face contact with participants”.
Some studies continued to suffer “a significant reduction in their recruitment figures”, the paper noted.
Mr Gleeson said Azura’s trial, which is looking at an ointment to help prevent an ailment known as “dry eye”, had been paused for a period of time but the timing of a key registration study was on track for late this year or early next year.
He was speaking after the unlisted Azura, which started in 2014, last week raised $28 million from investors including Brandon Capital’s Medical Research Commercialisation Fund, OrbiMed, TPG Biotech and Ganot Capital. The company has raised almost $53 million so far.
Support for the ASX-listed biotechnology sector has remained buoyant. A report this month by analysts at Bioshares noted that $1.067 billion had been raised so far this year, just under the $1.08 billion raised for all of 2019. Mr Gleeson said investors were still backing unlisted investments with the right quality and management.
Azura, which is headquartered in Israel but has operations in Australia and the US, is focusing on a compound that it hopes will prevent problems with Meibomian gland dysfunction, a cause of dry eye. Dry eye, according to the medical organisation Mayo Clinic, is an irritation caused when tears do not provide enough lubrication for eyes.
Azura uses the active ingredient selenium disulfide, which is used in anti-dandruff shampoo Selsun Blue. But Mr Gleeson said washing the scalp required detergents and penetrating agents that are “totally toxic to the ocular surface”.
So Azura has used a special method to create a compound that can be safely applied to eyelids and well-tolerated. That provides some intellectual protection in theory. “If someone wants to put Selsun Blue shampoo near their eye, go right ahead. You’ll only ever do it once,” Mr Gleeson said.
He said current treatments, addressing a market of 30 million Americans, included eye drops. “Our goal is to develop a treatment that addresses the problem at the source,” he said.
The ointment is applied to the lower lid and the key compound is designed to tackle a build-up and shedding of proteins in the Meibomian gland, which the company says is a root cause of the dysfunction.
The results from recent tests had not yet been peer reviewed but the fact existing current investors felt confident to put in an additional $28 million was “testament to confidence in the data”, he said.
Assuming everything goes smoothly with two registration studies, Mr Gleeson said Azura could anticipate filing for approval with the US Food and Drug Administration by the end of 2023. Risks included identifying the right dosage, he said.
Liam Walsh
The Australian Financial Review
26 October, 2020
