This randomised, double-blinded, placebo-controlled, cross over study will treat patients with Zelda’s proprietary insomnia formulation as well as a placebo.
The medicine for the trial has been manufactured to pharmaceutical grade GMP standards by a Europe-based speciality manufacturer.
Dosing is on-track for completion by December 2019 with preliminary results expected by February 2020.
Commercialisation planned if trial successful
Zelda’s managing director Richard Hopkins said: “This is an important milestone for the trial.
“I acknowledge the hard work and dedication from the team at the UWA sleep centre.
“Should the trial be successful, the company will move to immediately commercialise this formulation in all major global medicinal cannabis markets."
Proposed merger with US-based Ilera Therapeutics
On 9 October 2019, Zelda announced plans to merge with Ilera Therapeutics, a US-based privately held medicinal cannabis and cannabinoid science company.
Subject to approval from Zelda shareholders, and all conditions of sale being met, Zelda is proposing to acquire 100% of Ilera Therapeutics through an all-scrip transaction.
The merger will bring together a world-class portfolio of revenue-generating medicines and products undergoing clinical development that are expected to enter the market from 2020.
Hopkins added: “Zelda’s proposed merger with US-based Ilera Therapeutics will expand our access to the world’s largest cannabis markets with approximately four million registered medicinal cannabis patients.
“Zelda’s strategic partnership with European medicinal cannabis group HAPA Pharm BV also helps us access the world’s fastest growing markets outside the US.”