Zelira Therapeutics’ diabetic nerve pain drug outperforms Pfizer’s Lyrica
Perth-based Zelira Therapeutics (ASX: ZLD) has confirmed its cannabinoid-based diabetic nerve pain drug ZLT-L-007 has outperformed Pfizer’s commercially-available medication Lyrica (Pregabalin) in a multi-arm, head-to-head, US-based clinical trial.
Zelira partnered with Pennsylvania-based global contract research organisation Affinity Bio Partners to manage the trial which involved 60 subjects to evaluate the efficacy, safety and tolerability of ZLT-L-007 against Lyrica.
Topline results demonstrated that ZLT-L-007 achieved a significant reduction in NRS (numerical rating scale) pain scores, indicating a decrease in symptom severity.
In certain cases, it was reported to provide up to four times the observed pain relief compared to Lyrica.
Zelira chief executive officer Dr Oludare Odumosu said the compelling outcome gives the company confidence to evaluate the further progression of ZLT-L-007 into formal US Food and Drug Administration clinical trials.
“The findings of this unique comparative study underscore the exceptional efficacy of our treatments in managing pain, with ZLT-L-007 demonstrating the most substantial reduction in pain severity particularly at the 60-day and 90-day follow-up periods,” he said.
“We are particularly proud that it yielded positive results for our primary endpoint of safety… it aligns perfectly with our strategy of generating scientifically-rigorous and clinically-validated data for our patent-protected proprietary cannabinoid-based drugs.”
Chairman Osagie Imasogie said the achievements were particularly significant as Lyrica is a widely-recognised, multi-billion dollar revenue generator.
“This study has clearly indicated the market potential for our novel product which has outperformed the level of pain relief offered by Lyrica,” he said.
“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.”
Implications of results
Lead principal investigator Dr Bryan Doner said the implications of the results would be “incredibly promising and thrilling” for patients.
“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 participant blood pressure and other safety vitals remained unaffected, confirming that ZLT-L-007 is a well-tolerated product which delivers significant pain relief beyond what Lyrica can provide,” Dr Doner added.