The phase III study aims to deliver results next year, potentially opening the door for TGA approval of a repurposed low-dose treatment.
An Australian phase III trial on the use of oral minoxidil to treat hair loss is on track to deliver results early next year.
Professor Rodney Sinclair, editor of Dermatology Republic and head of Sinclair Dermatology in Melbourne, is leading the trial.
He said two-thirds of the recruitment had been completed and treatment has started in 60 patients, with about 30 places left on the trial to be filled.
“It’s been going well, and it’s quite likely that we would get phase three data read out in about another seven months,” he told DR.
“This is probably the first time ever in Australia that a drug’s been taken through the whole clinical trial development landscape in Australia with Australian funding, which is pretty exciting.”
Professor Sinclair said he expected they would initially apply for TGA approval to use oral minoxidil for androgenic alopecia, but he noted that once it was approved, it could be used off label for other indications.
High-dose minoxidil has been approved for use in Australia and other parts of the world for decades to treat high blood pressure. The version being trialled is a low-dose sublingual minoxidil tablet designed to help stop hair loss and promote hair regrowth.
“We’ve got IP for all hair loss conditions,” Professor Sinclair said.
“We’re hoping to prepare the dossier, submit that to the regulators in about June, and then work on their various timelines of response.
“In England, it’s 50 days. In Europe, it’s 70 days. In America, it’s nine months. Australia can be up to 12 months, I think, in terms of how long they have to respond.”
He said the fact that the drug was already approved for other conditions had been a bonus.
“It’s made it easier to get to this stage,” he explained.
“Because it’s a repurposed drug, we didn’t have to do any animal data, any toxicology data, we didn’t have to do a phase two study, and then we were able to develop a program with a single phase three study on the proviso that we get highly significant results.
“So, if we get a highly significant result, then one phase three study will be acceptable, whereas with a new molecule, you’d need two, and you’d also need more long-term safety data and long term follow up.
“Part of the reason why we can do it in Australia is because it is a repurposed drug. I didn’t have a lazy one to two billion lying around to develop something from scratch.”
The trial is open to men aged 18 years and over; who are in general good health; can attend the clinic five times over six months; and who have male pattern hair loss in the crown area of their scalp.
Exclusions include men who use or recently have used minoxidil, finasteride, dutasteride or anabolic steroids; who have had hair transplants, or scalp micropigmentation; who take blood pressure medications; and who have certain heart, kidney or liver-related health conditions.
For more information see here.
