Zelira Therapeutics Ltd. announced that it has published a white paper detailing the analysis of longitudinal, real-world data (RWD) generated from patients using ZENIVOL®. The agreement between Zelira Therapeutics and Emyria Ltd. (ASX:EMD) was to collect longitudinal, real world data for patients diagnosed with chronic insomnia who were treated with Zelira's ZENIVOL® product including de-identified patient data relating to diagnosis and co-morbidities, concomitant medications, dosages prescribed to patients and the ef ectiveness of ZENIVOL® using various clinical and subjective endpoints including the Insomnia Severity Index (ISI) questionnaire. The longitudinal, real-world data (RWD) of 94 patients was generated from two data sources: Dispensing data obtained as part of Zelira's regulatory obligations and Zelira sponsored observational trial conducted by Emyria's Emerald Clinics (n = 42).

The results published in a white paper are available on Zelira's website her e. A summary of the key findings include: Mean age of patients on ZENIVOL® was 54 years of age; the youngest and oldest patient were 6 and 78 years of age respectively. A substantial proportion of active ZENIVOL® patients were over the age of 65 suggesting that in the short to medium term, ZENIVOL® is safe and ef ective in this cohort. Mean time on ZENIVOL® was 4.3 months; maximum treatment time to-date was 10.8 months.

The primary indications of patients receiving ZENIVOL® was Chronic non-cancer pain (44%), Insomnia (36%) and post-traumatic stress disorder (12%). The Emerald Clinics ZENIVOL® patients, most reported being on a concomitant medication for pain relief ranging from opioids (i.e., oxycodone, codeine, tramadol), to benzodiazepines (diazepam) to over-the-counter pain relief medications (i.e., paracetamol, ibuprofen). ZENIVOL® appears to be ef ective: Overall, patients had a mean baseline ISI score of 19.5 (Moderate clinical insomnia), however after taking ZENIVOL® the mean ISI score significantly reduced to 14.3 (Subthreshold insomnia levels) (p<0.001).

At baseline, 15 patients were rated as having Severe clinical insomnia. After being on ZENIVOL®, 33% of these patients had reduced their ISI score to Moderate clinical insomnia levels, and 40% had reduced to Subthreshold insomnia levels. No improvement in the ISI score was seen in 27% of the Severe clinical insomnia patients.

At baseline, nine (9) patients were rated as having Moderate clinical insomnia. After being on ZENIVOL®, a third saw no improvement in their insomnia, whilst 44% reduced their ISI score to Subthreshold insomnia levels and 22% achieved ISI scores that rated them as having No clinically significant insomnia. For those patients with Subthreshold insomnia at baseline, 20% were able to reduce their ISI scores to No clinically significant insomnia, with the remainder maintaining a Subthreshold insomnia rating.