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Zelira Therapeutics’ (ASX:ZLD) share price almost tripled this morning, after announcing that its diabetic nerve pain drug outperforms multi-billion dollar Big Pharma drug, Lyrica.
Top line results demonstrated that Zelira’s proprietary ZLT-L-007 drug outperformed Lyrica by achieving a significant reduction in NRS pain scores, indicating a decrease in symptom severity.
ZLT-L-007 was found to be safe and well-tolerated, meeting the primary endpoint for safety with no Serious Adverse Events (SAE). The most substantial reduction in pain severity happened particularly at the 60-day and 90-day follow-up periods.
The study also met its secondary endpoints, including significant decreases in Visual Analog Scale (VAS) and Short-form McGill scores, among others.
These compelling outcomes have now provided confidence for the company to evaluate the further progression of ZLT-L-007 into formal FDA clinical trials.
“The results align perfectly with our strategy of generating scientifically rigorous and clinically validated data for our patent- protected proprietary cannabinoid-based drugs,” said Zelira CEO, Dr Oludare Odumosu.
Additional insights from the full study will be reported, as they become available, during FY 23-24.
Lyrica (pregabalin) is a multi-billion dollar drug developed by Pfizer.
The drug is commonly prescribed to manage chronic pain associated with nerve damage caused by conditions like diabetic neuropathy and post-herpetic neuralgia (nerve pain following shingles).
“In certain instances, ZLT-L-007 provided up to four times the observed pain relief when compared to Lyrica,” said Zelira’s chairman, Osagie Imasogie.
Lyrica has historically achieved peak year annual sales of approximately US$5 billion, clearly indicating the market potential for Zelira’s ZLT-L-007.
In other biotech news today, Neurotech was granted a two-year extension of NTI164 treatment for autism trial participants to start compassionate use.
The Human Research Ethics Committee (HREC) approval means that ASD patients who participated in the Neurotech Phase I/II trial could remain on treatment for an additional two years.
It is expected that 11 ASD patients will transition to the compassionate use (SAS-B) program from Q3 of this year.