It’s a long journey to get a drug from hypothesis to market but a few ASX biotechs are closer than their peers, due to release Phase III clinical trial results this year.


What are Phase III trials and why are they important for ASX biotech stocks?

Phase III clinical trials occur after Phase I and Phase II and shows that a drug can work in a large population.

The risk is reduced because Phase I and II have proven the drug is safe and has efficacy in a small group of people.

Global research has shown every 1000 drug candidates have only a 7 in 1000 chance of making it to market but having reached Phase III, the odds are higher – a 62 per cent chance.

As well as this, Phase II has been the “make or break” phase for many ASX biotechs; we seen successes such as Opthea (ASX:OPT), and failure such as Factor Therapeutics (ASX:FTT).

Nevertheless, Phase III trials typically take longer than Phase II.

For instance Opthea raised capital for its Phase III clinical trials (against wet-AMD and DME) in late 2019 and hopes to reveal results in the first half of 2023 whereas its Phase II clinical trials took under two years.

But there are a handful of ASX biotech stocks – four to be exact – which are set to release Phase III results before 2021 is out and Stockhead has recapped the quartet.


Dimerix (ASX:DXB)

Dimerix is conducting three phase III studies and two of them are due before 2021 is out.

The pair due this year both involve Dimerix’s chemokine receptor (CCR2) blocker DMX-200 in large-scale assessments of COVID-19 respiratory treatments but are with different research.

The good news for shareholders is whatever the outcome, Dimerix will not be on the hook for the costs because these were initiated by the investigators.

One of these studies resulted in a $1 million grant from The Australian government’s Medical Research Future Fund.

And while regulatory approval is typically another complex step for drugmakers, Dimerix’s path could be easier with regulators typically quick to grant emergency use authorisation to any drug or treatment that can fight the pandemic.

Dimerix’s other Phase III clinical trial – due next year – is against a rare kidney disease known as FSGS (focal segmental glomerulosclerosis).

Dimerix (ASX:DXB) share price chart


Neuren Pharmaceuticals (ASX:NEU)

Neuren targets various rare brain disease one of which is Rett syndrome which occurs predominantly in girls.

It is conducting a 12-week study enrolling 180 patients and expects to report the results in the trial in the fourth quarter of this year.

Neuren is also targeting four other related disorders with a second compound, NNZ-2591 and is set to begin Phase II trials in three of them this year.

In 2021 the company has already achieved EU Orphan Drug designations for three diseases and reported Phase I trial results for NNZ-2591.

Drugs designated as Orphan drug are intended to treat a disease so rare that it is uneconomical to develop and government bodies grant benefits to make production economical.

Neuren Pharmaceuticals (ASX:NEU) share price chart


Telix Pharmaceuticals (ASX:TLX)

This $1.2 billion ASX biotech stock has a Phase III trial evaluating TLX250-CDx as a diagnostic agent targeting clear cell Renal Cell Carcinoma (ccRCC) in 252 patients across Australia and North America.

ccRCC is a type of kidney cancer which is the most common type in adults.

Telix anticipates completing patient enrolment in the middle of the year and with the study running 42 days for each participants it hopes to have the trial data-set available in “late 2021”.

The company has also pencilled in that time to schedule a meeting with the FDA regaring a Biological License Application.

Telix has also begun a Phase III study for another drug, TLX591, against prostate cancer. The study has begun in Australia but will expand to the US, Europe and possibly Asia in the next nine months.

Telix Pharmaceuticals (ASX:TLX) share price chart


MGC Pharmaceuticals (ASX:MXC)

This cannabis focused company is also fighting COVID-19, conducting a Phase III clinical trial across Israel and Brazil with its anti-inflammatory medicine CimetrA.

MGC received ethics approval back in March and hopes to have results available in the fourth quarter of this year although interim results are anticipated to be available in August.

MXC Pharmaceuticals (ASX:MXC) share price chart


At Stockhead, we tell it like it is. While MGCC Pharmaceuticals and Dimerix are Stockhead advertisers, they did not sponsor this article.