Zelira Therapeutics (ASX:ZLD) has announced the publication of its clinical study report, which evaluated its ZLT-L-007 in 60 adults diagnosed with diabetic neuropathy.
ZLT-L-007 is Zelira's proprietary cannabinoid-based therapy. The study was a head-to-head trial of ZLT-L-007 against pregabalin monotherapy and ZLT-L-007 in combination with pregabalin.
The primary endpoint was the change in Daily Pain Numeric Rating Scale (NRS) scores from baseline to days 30, 60, and 90. Secondary endpoints included changes in Visual Analog Scale (VAS), Sleep Interference (DSIS), Pain-Ten Domains, Neuropathic Pain Symptom Inventory (NPSI), Short Form McGill Pain Questionnaire (SF-MPQ), and Hospital Anxiety and Depression Scale (HADS). Safety was assessed through vital signs, liver and renal function tests, and the reporting of adverse events.
ZLT-L-007 monotherapy achieved the primary endpoint, resulting in an 85 per cent median reduction in daily pain scores by day 90. This compared to a 67 per cent reduction for the ZLT-L-007 and pregabalin combination, and 30 per cent for pregabalin monotherapy. ZLT-L-007 monotherapy also achieved multiple secondary endpoints.
"The results of this POC [proof of concept] study demonstrates ZLT-L-007 as a highly promising cannabinoid-based therapy that not only relieves pain more effectively than Lyrica [pregabalin] but also addresses symptom complexity, sleep disturbance, emotional burden, and overall quality of life," said Zelira.
CEO Dr Oludare Odumosu said, "This study is a turning point not just for Zelira, but for the millions of patients living with the daily burden of diabetic neuropathy. The results reinforce what we’ve always believed—ZLT-L-007 is more than a product, it’s a platform for transformational change in how we approach and manage chronic pain conditions globally. As a company committed to advancing science with purpose, we are incredibly energised by both the clinical promise and the broad therapeutic potential this data represents. This successful proof-of-concept study validates our product development model and underscores our ability to generate meaningful clinical outcomes within a regulated pharmaceutical framework. It strengthens our long-term value proposition to investors and highlights the scalability of our cannabinoid-based drug development pipeline. For our strategic partners, it is a compelling demonstration of Zelira’s execution capabilities, clinical discipline, and commercial readiness. We are just getting started."
