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Today’s st o ck hea d

https://unauthorised investment adv...f-releasing-phase-iii-clinical-trial-results/


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 * has recapped the quartet.

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.