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Shares in Perth-based medical cannabinoid developer Zelira Therapeutics’ (ASX: ZLD) rocketed by than 256 per cent today after the company revealed its diabetic nerve pain drug had delivered what it says are superior results to Lyrica, Pfizer’s global market-leading neurology product.
The shares jumped from a close of 94c yesterday to a high of $3.35 this morning on the news, but the shares settled back to $3.31 by this afternoon - up 230 per cent for the day.
Zelira says its proprietary drug ZLT-L-007 went head to head against Lyrica in an IRB-approved study that directly compared the product’s efficacy.
Lyrica, which is used to treat pain caused by nerve damage due to diabetes, shingles infection and spinal cord injury, is worth US$5 billion ($7.7 billion) in sales annually to Pfizer.
Zelira says the topline results of the study demonstrated that ZLT-L-007 ‘outperformed Lyrica, achieving a significant reduction in NRS (numerical rating scale) pain scores, indicating a decrease in symptom severity’.
The ZLT-L-007 product was found to be ‘safe and well-tolerated’, with the findings paving the way for the company to proceed to formal clinical trials of the product in the US.
Zelira partnered with Pennsylvania-based global clinical research organisation Affinity Bio Partners to manage the clinical trial which was conducted in the US.
Dr Bryan Doner, the lead principal investigator, describes the results as ‘groundbreaking’, adding that they contribute to the advancement of research in the cannabinoid pharmaceutical sector.
“The implications of these results for patients are incredibly promising and thrilling,” Doner says.
“Through this rigorously designed study, we have demonstrated that ZLT-L-007 is a safe, effective, and well-tolerated alternative for patients who would typically seek a Lyrica level of pain relief.
“I am particularly pleased that the topline data reveals no reported serious adverse events, and participants’ blood pressure and other safety vitals remained unaffected throughout.
“This confirms that ZLT-L-007 is a well-tolerated product that delivers statistically significant pain relief, surpassing the levels achieved by Lyrica.”
Zelira’s chairman Osagie Imasogie says that, in some instances, ZLT-L-007 provided ‘up to four times the observed pain relief when compared to Lyrica’.
“This compelling outcome gives us confidence to evaluate the further progression of ZLT-L-007 into formal FDA clinical trials,” he says.
“Our company remains focused on providing relief to patients and creating new cannabinoid derived drugs to deliver clinically validated safe and efficacious solutions to patients in need, across several therapeutic areas.”
The Perth-based Zelira (formerly known as Zelda Therapeutics) currently operates out of the US following the appointment of Philadelphia-based Oludare Odumosu as global managing director in 2021.
The company last year abandoned merger negotiations with fellow Perth company Health House International (ASX: HHI) after a tough year for the CBD sector.
The company last week announced that it had secured US$3.25 million ($5 million) in extra funding from the HOPE Special Purpose Vehicle to support clinical trials of its HOPE 1 product to treat autism, taking the total amount raise to US$11.85 million ($18.25 million).
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