Cann’d: clinical trials show no difference between cannabis capsules and placebo

Since the easing of regulatory red tape and wider societal acceptance of utilising cannabis for its medical properties, the medicinal cannabis industry has become an intense battleground as researchers have raced towards commercial products. In the case of Cann Group (ASX: CAN) though, they might have just triggered a land mine. 

Undertaking any form of clinical trials is a costly exercise for medical research companies and it seems like Cann Group has researched Phase 3 with their Satipharm CBD (cannabidiol) capsules tested in 257 people before results showed the drug had no significant impact on participants. 

The Phase 3 trial has seen the capsules compared between a randomised group that received the drug, and a placebo group. 

Interim data from the trials however, has shown that there was no “statistically superior response” from the participants receiving the drug compared to the control group that were dosed with the placebo. 

Commercially, this is just about the worst case scenario for a medical research company that has poured millions of dollars developing the drug to reach Phase 3 trials, unable to deliver statistically significant results required by a regulator to approve the drug for public consumption. 

In light of these interim results, Cann Group has confirmed that there will be a delay in their submission to register their Satipharm CBD capsules with the Therapeutic Goods Administration (TGA) with no updated timeline provided by Cann Group. 

The intention of the trials was to produce clinical data that would enable Cann Group to register a low-dose CBD medicine for over-the-counter sale, making it available to consumers at pharmacies without requiring a prescription. 

The writing may have already been on the wall for Cann Group however, with the Company’s former CEO Peter Crock standing down from his role in October 2022. Since then, Cann Group raised $8.18 million from its shareholders under a Share Purchase Plan at $0.22 per share where funds would be applied towards the commercialisation plans of Saltipharm and upgrading their dried flower packaging capacity. 

With the release of this deflating interim trial data, it’s been a rocky start for newly appointed CEO Peter Koetsier who commenced in the role just three days ago.