Neurizon Therapeutics Limited

ASX:NUZ

Neurizon Therapeutics Limited

ASX:NUZ
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Forum Topics NUZ NUZ Healey ALS Platform Trial 2026

Pinned straw:
lastever
Added 3 months ago

The first patients are expected to begin enrolling for Neurizon’s regimen of the Healey ALS Platform Trial in the next few weeks.

This is not an ordinary clinical trial. It is an ongoing, multi-candidate effort by the ALS medical community to identify potential treatments via a shared stage 2 placebo-controlled system. It is being run out of Mass General Hospital, the largest teaching hospital of Harvard Medical School, with 70 trial sites across the US.

Last week, industry publication Fierce Biotech, held a webinar with the trial coordinator, the Neurizon CEO, and the 2 lead investigators. I recommend watching it for:

  • an overview of the platform trial
  • Neurizon’s scientific rationale and stage 1 trial results
  • the feeling the lead investigators have for Neurizon’s candidate.

Most people would know that ALS is a fast, terminal neuro-degenerative disease with no known cure. So patients need a treatment, now. With this platform trial, they have not only the latest available stage 2 candidates, but also a 3:1 drug to placebo sorting ratio.

Since 2020, 7 other candidates have been trialed. Despite not reaching their endpoints, 2 candidates showed enough life extension signal to be ear-marked for stage 3 trials (to be run independently of Healey). The last trial ended in mid-2025.

Following very interesting stage 1 results, Neurizon will be the 8th candidate, and benefits from the well-established system and shared data from 1500 patients, with:

  • a clinic network of 70 US trial sites
  • an improved bio-marker screening protocol for best patient outcomes
  • a longer trial time of 36 weeks (previously 24) for improved signal

Hopefully it’s clear this is maximum exposure for Neurizon, and a state-of-the-art, tried and tested trial system that will minimise the risk of any further FDA hiccups.

Healey regimen I:

  • n=160, 3:1 randomised treatment:placebo
  • First dosing in the coming weeks (Q1)
  • 36 week double blind, followed by 36 week active extension (similar to an OLE).
  • Therefore, primary results readout should be mid-2027.

Neurizon will be joined at some stage by an Eli Lily candidate and one other (with correspondingly increased patient pool, I believe), however until that happens all active treatment enrolled patients will be assigned to Neurizon.
lastever
Added 3 months ago

First patient dosed

3
lastever
Added 2 weeks ago

Neurison published that 59 of 70 Healey trial sites are already active across the US. 123 patients have been screened, of whom 62 have been randomised and 48 have been dosed. That's the benefit of winning a place in an established trial network. Full enrolment with 160 randomised this year seems easily achievable, they might even be early if it accelerates as anticipated.

An interesting scenario is emerging: The 2 other booked candidates, including one from Eli Lily, have not commenced yet. If Neurizon remains the only active regimen, then they will potentially need to expand their own enrolments to power up the placebo group (since the 3 regimens were supposed to share control groups). From what I gathered, it is already contracted with Healey how this scenario would be managed (and funded). But it's not published, so Hopefully Neurizon will disclose the details if it becomes a live issue.

If Neurizon remains the only candidate, then all the community's attention and hopes will be on them. And they will then have an unencumbered and highly anticipated run into the open label extension half.

Another point here is that there will be no interim data readout. As long as the trial continues beyond a clear halfway point, then it has not been deemed futile. So following full enrolment, no news is good news on that front.

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lastever
Added 1 day ago

3 months into the Healey ALS trial and already almost half way to the recruitment goal. 76 patients assigned with 60 dosed and 61 active trial sites.

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