Phase III trials: When the science project has to ‘grow up and get a job’

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Several ASX companies are undertaking pivotal phase III trials with Dimerix working particularly hard on its trial design to ensure ... Read More The post Phase III trials: When…

Phase III is where promising drug candidates must graduate and prove their worth. Pic: Getty Images

The journey from lab to clinic is a costly and complex one for biotech companies, encompassing years of R&D and clinical testing with the final hurdle to jump being a phase III trial.

Often referred to as pivotal trials because of their importance, phase III typically evaluates a treatment’s safety and effectiveness in larger patient populations.

Some companies also conduct combined phase II/III trials, which can be designed to generate the pivotal evidence needed for regulatory approval.

Morgans healthcare analyst Iain Wilkie said the stakes were particularly high in these late-stage trials.

Positive results can provide critical support for approval submissions to regulatory bodies such as the US Food and Drug Administration (FDA) or Australia’s Therapeutic Goods Administration (TGA), open doors to commercial partnerships and new revenue streams.

However, a disappointing outcome can derail years of R&D and weigh heavily on a company’s share price, which unfortunately we’ve seen with several ASX companies.

“The way I think about it is phase III is where the nice little science project has to grow up and get a job,” Wilkie told Stockhead.

Wilkie said the design of a phase III trial could be critical to its eventual success. He said often phase III trial failures were not necessarily unexpected, with weaknesses in earlier clinical data or trial design providing warning signs.

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