Zelda in cannabis autism trial

31/01/2018 - 12:20

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Clinical trials company Zelda Therapeutics aims to pave the way for the use of medicinal cannabis to treat a range of disorders.

Stewart Washer says Zelda Therapeutics is catching up with market use, given the nature of cannabis regulation. Photo: Attila Csaszar

Perth-based clinical trials company Zelda Therapeutics is growing its global medicinal cannabis operations as the scope of the sector broadens, embarking on a program of human trials targeting sleep disorders, autism and eczema.

Zelda has most recently partnered with the Children’s Hospital of Philadelphia (CHOP) to assess the effects of cannabis on autism, and the University of Western Australia’s Centre for Sleep Science, where it will hold clinical trials for insomnia.

Zelda executive director and co-founder Stewart Washer told Business News the local cannabis industry was catching up with the market, which was already obtaining medicinal cannabis from alternative sources.

Authorised doctors have been legally entitled to prescribe medicinal cannabis in Western Australia since late 2016.

“We’ve gone from scepticism and arms folded to people beckoning us in to come and work with them; and that shift has been driven, obviously from that evidence, but patients globally have risen up,” Mr Washer said.

He said Zelda was applying science and medicine to discover what the market was using and how it could make that in a stable, safe, and price-effective way.

“We know medical cannabis works for chronic pain and other things, but things like autism, there’s a lot of anecdotal evidence but people haven’t done the formal clinical studies, so Zelda’s leading the way,” Mr Washer said.

He said Zelda partnered with Chilean patient advocate group Foundation Daya last year to conduct observational trials on the use of medicinal cannabis to treat autism in children.

The Chilean trials found 71 per cent of patients improved in at least one core symptom, while 67 per cent of patients showed significant overall improvement.

“We (Zelda) have now got patents on formulations for autism that we plan to take to clinical trials in Chile this year,” Mr Washer said.

He said the observational trials at the Children’s Hospital of Philadelphia, due to begin early this year, would potentially present new formulations that could prove effective with the 30 per cent of patients unresponsive to its formula trialled in Chile.

Mr Washer said the Philadelphia facility was one of the leading paediatric hospitals and research facilities in the world. He said Zelda and CHOP would not be giving cannabis to patients, but would be studying patients who were already using cannabis from various sources in the US.

“We’re really looking to gain (insights into) how their symptoms are being managed, but most importantly we’re going to analyse what they’re actually taking, because most of the time these producers in the US don’t quite know what’s in their own medicines,” Mr Washer told Business News.

Zelda should have results for its US trials mid-2018, while clinical trials for insomnia should be completed around the same time.

An insomnia product could be ready for market within the following six months, Mr Washer said.

Eczema trials, focused on a topical anti-inflammatory treatment, would be a priority further down the track, he said.

Mr Washer is also a co-founder of medicinal cannabis manufacturer AusCann Holdings, chaired by his father, Mal, and managed by his sister, Elaine Darby.

AusCann is a potential customer for Zelda Therapeutics’ medicine, Mr Washer said.

“AusCann’s really focused on manufacturing and producing high-quality pain medications for Australian patients, and now Chilean patients are the export market that has opened up,” he said.

Despite AusCann being granted approval in May last year to grow and produce cannabinoid products, Mr Washer said Australia was still too restrictive in terms of patient access because levels of paperwork and doctor scrutiny were high.

“For Zelda it doesn’t matter as much because we’re more international in our focus and rollout, but we do want Australian patients to have access to this,” he said.

Mr Washer said Zelda currently had a market capitalisation of almost $90 million, which had grown from about $15 million since inception in 2003.

“The good thing is, most biotechnology companies that are in a phase-two trial, which is where we’ll be in the next few months with insomnia, are in the hundreds of million dollars at least,” he said.

“And then if you do these trials successfully and license them out, you can get significant income from the licensing deal, upfront and milestones and then a royalty on sales; so Zelda could rapidly go into the hundreds (of millions).”

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