Biopharmaceuticals company Zelira (ASX: ZLD) is taking a stab at redemption. After a misstep this July by not announcing its German expansion, the Company lost shareholder trust. Now, it is attempting to get it back with new milestones revealed on time for its clinical trials targeting diabetic nerve pain.
The trial has been designed as a multi-arm head-to-head against a major Big Pharmaceutical company’s multi-billion dollar revenue drug. The medical cannabis producer has brought on 60 patients and will be partnering with Pennsylvania’s contract research organisation Affinity Bio Partners to manage this clinical trial.
Zelira Therapeutics CEO & Managing Director, Dr Oludare Odumosu, commented, “Positive results will validate the real potential for creating safer and efficacious cannabinoid medicines for the treatment of diabetic nerve pain. 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 study was powered to show the statistical differences among 60 patients. There will be 20 patients in each group a.k.a. “arm”. Subjects in group 1 will already be consuming the reference drug at the prescribed dose as recommended by their doctor. Group 2 subjects will receive the investigative drug—one capsule by mouth twice daily—along with the prescribed drug. If there’s no response after two weeks, the principal investigator can increase the dosing to three times daily.
After that, if the investigator feels that the patient still needs an additional dose, Zelira is all for providing an additional capsule, increasing the consumption frequency to four times a day. Patients will be taking the drug in their own homes.
In the third and final group, patients will receive one capsule of Zelira’s proprietary investigational drug, ZLD-007, by mouth twice daily. If there’s no response after two weeks, the investigator is free to boost the dosing to thrice daily and, again, is free to provide an additional dose if the need arises.
CEO of partner organisation Affinity Bio Partners, Christina DiArcangelo, said, “Despite having to overcome challenges such as the COVID-19 pandemic, and educating subjects about new cannabinoid-based therapies including terpene education, Affinity Bio Partners is proud to have been able to successfully complete subject enrollment for this study alongside its partners Spectral Analytics Precision Tele-Monitoring for electronic patient reported outcomes and electronic data capture, and non-profit patient advocacy sponsor, Affinity Patient Advocacy for subject recruitment along with the clinical trial sites.”
Zelira is a global biopharmaceutical company conducting research, development and commercialisation of clinically-validated cannabinoid-based medicines. Its focus is on creating branded marijuana-based medicines to treat medical conditions like insomnia, autism and chronic non-cancer pain.
In July 2022, the Company had initiated a trading halt after it failed to announce that it was granted German regulatory approval for the sale of its insomnia medication, Zenivol®. It received the approval on July 11, but only released the information on July 13, blaming an “informal email” that brought them the news and the time zones that resulted in some jet lag in its deliverance. In doing so, it ticked off investors big time, causing its share price to fall considerably from $3.50 at the time with ZLD shares now trading around $1.00 four months later.
Alinda is a Business Reporter for The Sentiment
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