• Zelira to test own proprietary drug against a Big Pharma drug
  • Little Green Pharma terminates supply agreement with Four 20 Pharma 
  • Invex enrols first patient in Phase III clinical trial 


Zelira to test drug against a Big Pharma drug

Cannabis stock, Zelira Therapeutics (ASX:ZLD) rose 2.5% after announcing the completion of its enrolment for the Diabetic Nerve Pain Drug Trial.

60 patients have been enrolled to evaluate the efficacy, safety and tolerability of its proprietary, patent protected product.

The IRB approved trial has been designed as a multi-arm head-to-head against a major (un-named) Big Pharma company’s multi-billion dollar revenue drug, using Zelira’s proprietary, patent protected product.

This unique study presents multiple prospects for positive readouts on study endpoints.

A positive result on one or more endpoints would be a landmark event for Zelira in its strategy to produce rigorous, clinically validated data on its proprietary cannabinoid-based drugs.

“Above all, positive results will validate the real potential for creating safer and efficacious cannabinoid medicines for the treatment of diabetic nerve pain,” said Zelira CEO, Dr Oludare Odumosu.

“In addition, results from this trial will also validate the safe and efficacious use of Zelira’s patent protected, proprietary technology Zyraydi, which was used to formulate our investigational drug, in humans.”

The trial readout is expected in Q1 2023.


Little Green Pharma terminates German deal

Another pot stock Little Green Pharma (ASX: LGP) rose 2% after terminating its exclusive supply agreement with Germany’s Four 20 Pharma GmbH.

Four 20 Pharma has not been able to satisfy its agreement with LGP to secure certain approvals in Germany.

As such, LGP has issued Four 20 Pharma with a notice of default and will now consider offering the high-THC SMS strain into the German market via its existing channels.

Separately, LGP says that the French Government has confirmed it will extend the period of the two-year French medicinal cannabis trial for a further 12 months until March 2024.

The company says it was in negotiations with the French Government in relation to an earlier request for the its continued participation in the trial, given that LGP is the largest supplier into the trial and has been providing products to trial participants free of charge.


Invex enrols first patient

Invex Therapeutics (ASX:IXC) announced that the first IIH (idiopathic intracranial hypertension) patient has been randomised into the IIH EVOLVE Phase III clinical trial at VisionSA in Adelaide.

Clinical trial sites are now active and open for patient recruitment in Australia and the UK.

The IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will randomise 240 patients with newly diagnosed IIH to determine the efficacy and safety of lead drug Presendin versus placebo.

The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.


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