Australia: Exotic. Home to strange animals and striking landscapes. And also, a growing market in which to conduct Phase 1 clinical trials for biopharmaceutical companies.
MassBio’s upcoming panel discussion on Phase 1 clinical trials in Australia will examine in depth the advantages and challenges of working down under. (Tuesday, Oct. 9, 8:00-10:00 a.m. at MassBio, 300 Technology Square, 8th floor, Cambridge.) But to get members thinking about how conducting early-stage clinical trials in Australia, we spoke with one of the panelists, David Lucchino, CEO of Frequency Therapeutics and chairman of MassBio.
Frequency Therapeutics is a four-year-old company that is advancing a novel type of regenerative medicine that uses small molecules to activate dormant progenitor cells. While the company plans to apply its Progenitor Cell Activation platform to treat various diseases, its most advanced program is aimed at chronic noise-induced hearing loss. Last December, Frequency announced positive results from a first-in-human safety study in cochlear implant patients of its experimental treatment, FX-322, for hearing restoration, conducted in Australia.
“Obviously, Australia is on the other side of the world,” said Lucchino, “but there’s a lot to love about working there, including substantial government reimbursement, flexibility from the clinical community, and a passion for helping patients with novel therapies.”
The tax incentives are helpful, said Lucchino, but they were not the primary reason for launching a trial in Australia, said Lucchino.
“Australian researchers have unique expertise in hearing,” said Lucchino. “The modern, multichannel cochlear implant was pioneered at the University of Melbourne, and that institution continues to lead in the science of hearing disorders. That was crucial for us.”
Conducting trials in Australia can become part of a global market strategy. But the distance and time difference involved in working with Australian partners cannot be minimized, said Lucchino.
“You’re on a totally different time schedule from your clinical partners. That really lengthens the feedback loop. We made multiple trips to Australia during the trial, and that’s really a lot to ask of your team.”
Finally, there’s no substitute for having strong clinical operations at the host site, said Lucchino. “Clinical operations are important no matter where you go, but particularly halfway around the world.”
The Phase 1 trial of FX-322 was led by Stephen O’Leary, M.D., chair of otolaryngology at the University of Melbourne. The study met all its endpoints, showing the experimental treatment was well tolerated with no drug-related adverse events reported. The study further confirmed the bioavailability of FX-322 both locally and systemically.
In August, Frequency initiated a Phase 1/2 single dose clinical trial to further evaluate FX-322 at several leading otolaryngology clinics in the U.S.
The panel discussion on Phase 1 Clinical Trials in Australia will be moderated by Nicola Watkinson, senior trade & investment commissioner and deputy general counsel at the Australian Trade & Investment Commission. Other speakers include Cameron Johnson, CEO of Nucleus Network; Douglas E. Onsi, managing director of Healthcare Ventures; Stewart Walker, vice president, North America for Cosec Consulting, and Leslie Williams, CEO of ImmunsanT Inc. Register here.
– DAVID LUCCHINO, CO-FOUNDER, PRESIDENT AND CEO OF FREQUENCY THERAPEUTICS & CHAIRMAN OF MASSBIO BOARD