This Cannabis-Based Drug Has Outperformed Pfizer's Lyrica In Clinical Trials: A New Dawn For Diabetic Nerve Pain Management?

Zelira Therapeutics Ltd ZLD ZLDAF, a leading player in cannabinoid medicine research, has successfully demonstrated that its proprietary drug for diabetic nerve pain, ZLT-L-007, surpasses the efficacy of Pfizer Inc. PFE's market-leading drug, Lyrica. Shares of Zelira traded up more than 220% on the Australian Securities Exchange on Wednesday.

The clinical trial, featuring a meticulously devised multi-arm, head-to-head comparison targeting diabetic nerve pain, put ZLT-L-007 against Lyrica, a drug that historically notches up peak year annual sales of approximately $5 billion. The aim was to assess ZLT-L-007's ability to compete against the established analgesic properties of Lyrica.

Topline results reveal a significant reduction in NRS pain scores for those administered ZLT-L-007, denoting a clear decline in symptom severity. Beyond proving its efficacy, ZLT-L-007 demonstrated impressive safety, and tolerability, and even exceeded Lyrica's ability to manage pain in some instances. In the safety and efficacy dual, no Serious Adverse Events (SAE) were recorded, hitting the primary endpoint for safety.

Zelira’s chairman, Osagie Imasogie, reflected on the results with confidence and optimism. "The findings empower us to evaluate the further progression of ZLT-L-007 into formal FDA clinical trials," he stated. Imasogie further emphasized Zelira's commitment to developing safe, effective cannabinoid-derived drugs to meet patients' needs across various therapeutic areas.

In addition to its primary victory, ZLT-L-007 met secondary endpoints, including significant decreases in Visual Analog Scale (VAS) and Short form McGill scores, among others. Zelira Therapeutics CEO and managing director, Dr. Oludare Odumosu, hailed this as a testament to Zelira's rigorously scientific and data-driven approach to developing patent-protected proprietary cannabinoid-based drugs.

ZLT-L-007's success has been facilitated by Zelira's innovative Zyraydi technology. This tech enables the production of an easy-to-swallow, pharmaceutical-grade size 2 capsule, offering patients a simple yet effective pain management solution.

As Zelira continues its promising trajectory, the company plans to release further insights from the full study throughout FY 2023-2024. The results underscore Zelira's successful "Launch, Learn and Develop" strategy, paving the way for future FDA clinical trials, and, potentially, regulatory approval for ZLT-L-007.

The trial results indicate not just a win for Zelira, but an evolutionary step for the cannabis-based pharmaceutical industry, nudging it further into mainstream recognition and acceptance.