Zelira, PolyNovo prove even a pandemic can't stand in the way of good clinical results

In proof that biotechs will deliver market returns even during a pandemic, two companies this morning have issued clinical trial results and watched their share prices rocket.

Pot stock Zelira Therapeutics (ASX:ZLD) has received the full report for its phase 1a/2b medicinal cannabis trial for insomnia, and says it met both primary and secondary endpoints — the key outcomes the trial is supposed to meet.

The stock opened up 31 per cent before falling back to a 20 per cent rise on the intraday price, at 4.3c.

The company says the formulation produced statistically significant and dose responsive improvements in Insomnia Severity Index (ISI) scores compared to the placebo, meaning different doses helped people sleep and also had different effects on their ability to sleep.

Across all participants in the trial, ISI scores decreased by 26 per cent while those on the highest dose achieved a 36 per cent reduction.

Patients in the trial reported improved objective and subjective measures of total sleep time, night wake times, time to sleep, quality of sleep, and how rested they felt when waking up.

They also reported improved levels of stress, fatigue and social functioning.

The trial into chronic insomnia used a randomised, double-blind, cross-over design, so neither patients nor researchers knew who was taking what, at the University of Western Australia (UWA) Centre for Sleep Science.

Twenty-three patients were treated for 14 nights with ZTL-101 and 14 nights with placebo, separated by a one-week washout period.

The primary endpoints were that it was safe and worked. The secondary endpoints were that it improved objective and subjective measures of insomnia, and quality of life.

“This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia,” said Professor Peter Eastwood, the principal investigator and director at the UWA Centre for Sleep Science.

“The fact that ZLT-101 treatment achieved statistically significant, dose responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window.”

Burns victim cure

PolyNovo (ASX:PNV), which up until last year was a small cap, also bounced 31 per cent in early trade after saying a trial it started in 2015 into deep burn injuries hit primary endpoints.

The study was to see how well its NovoSorb treatment worked after it was applied to skin grafts and over time.

Thirty patients were recruited and 22 completed the study — four died due to serious adverse events not related to the treatment and four patients were lost to follow-up before study completion.

The primary endpoint was the percentage of split-thickness skin graft take (% SSG Take) within seven to 10 days after grafting as a proportion of the total amount of treatment applied.

“The concept of ‘take’ is commonly used in wound treatment outcome studies, where ‘take’ describes the percentage of device or skin graft incorporated into the wound bed,” the company said.

“Primary endpoint data was available for 26 patients, aged 18 to 70 years with deep dermal/full thickness burn injuries of mean size 47.5 per cent total body surface area (TBSA) and a range of 25 per cent to 70 per cent TBSA.”

Other dermal matrix treatments for burns have a target of 77 per cent SSG. PolyNovo’s had measures of 90.4 per cent after seven to 10 days, 99.9 per cent at three months, 99.8 per cent at six months and 100 per cent at 12 months.

The trial was originally designed to get ARTG registration in Australia and CE Mark approval in Europe, but the former was attained in August last year and the latter in December.

In other news:

Hair regrowth company Cellmid (ASX:CDY) is in hot water with the ASX after CEO Maria Halasz tweeted and Instagrammed about the company’s Chinese-made COVID-19 antibody testing kit a day before the news was released to market. The company’s excuse is that it was in a trading halt at the time and the information was with the ASX, and “it was not understood” that the social media policy (and ASX rules) were still applicable even if no one could trade their stock.

Brain cancer hopeful Kazia (ASX:KZA) says its glioblastoma treatment gave patients in its phase two study an extra 17.7 months of life, up from the 12.7 months the existing treatment offers. Its ability to slow the the growth of the tumour was 8.5 months compared to 5.3 months. The company is still in a trading halt.