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Cannabis

Zelira Therapeutics in discussions to license medicinal cannabis products in US

The company released interim results of an Insomnia Clinical Trial during the quarter, the first in the world to have a primary endpoint assessing the impact of a full-spectrum cannabis extract on sleep.

Zelira Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) is in discussions with third parties to license products in the US and secure agreements for distribution in emerging global medicinal cannabis markets including Australia, Germany and the United Kingdom.

In its March quarterly report, the company highlighted concluding the quarter with a cash position of A$4.02 million after completing a placement to raise more than A$4.64 million.

These funds will be used to accelerate Zelira’s plans to launch multiple products into global markets in the second half of 2020 as well as progressing clinical programs such as its Insomnia and Opioid Sparing trials.

The medicinal cannabis company also received its maiden revenues from Advanced Biomedics for its fist licensing deal for Hope™, which is anticipated to launch later in 2020.

Insomnia Clinical Trial (Perth)

From an operational standpoint, the company released interim results of its Insomnia Clinical Trial during the quarter having met its primary endpoints for efficacy and safety.

Results confirmed the ZLT-101 therapy achieved the primary endpoint of a statistically significant improvement in Insomnia Severity Index scores, a gold-standard measure of insomnia severity, in patients diagnosed with chronic insomnia compared to placebo.

A complementary pharmacokinetic (PK) sub-study was also initiated in the same patient cohort to provide important insights into the absorption of ZTL-101 following oral delivery.

Data from the PK sub-study and the final report for ZTL-101 will form the most comprehensive clinical data-pack for the use of medicinal cannabis to treat chronic insomnia.

Opiod Reduction Study (Melbourne)

Zelira is undertaking a study in collaboration with St Vincent’s Hospital in Melbourne to assess the safety and effectiveness of medicinal cannabis to reduce opioid dependence.

During the quarter, Emerald Clinics were engaged as a second site and the trial reached full enrolment with all patients subsequently completing dosing by early April 2020.

No serious adverse events have been reported to date and the company is on track to provide a final report in the current quarter.

Collaboration with US Parkinson’s Foundation

In January, the company entered into a collaboration with the Parkinson’s Foundation to gather insights from people with PD about their understanding of and use of medical cannabis and hemp-derived therapies.

Separately, Zelira will use survey insights in the future development of clinically validated medical cannabis for people with Parkinson’s disease.

It is aiming to launch its first product for Parkinson’s disease in the second half of 2020.