Five sites activated and five patients dosed in PROTECT-MI Phase IIa trial
Nyrada (ASX:NYR) announced on 30 October 2026 that five sites are now activated and five patients have been dosed in its PROTECT-MI Phase IIa clinical trial, up from three at the 16 October 2026 update. Recruitment is progressing towards the eighth patient, which triggers the first Safety Review Committee (SRC) meeting.
Liverpool Hospital (NSW) has now been activated, taking the network to five active sites. Site activation is the step that opens a hospital to screening and recruiting patients, so the expanded network is relevant to the company’s stated trial timeline.
Key points from the update:
- Five sites activated and screening patients
- Five patients recruited and dosed, up from three
- First SRC meeting triggered once the eighth patient is dosed
- Final patient dosing remains on track for mid-2027
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Trial network expands as recruitment builds
Where the five sites are
Liverpool Hospital (NSW) joins four other activated sites:
- Nepean (NSW)
- Sir Charles Gairdner (WA)
- Northern (VIC)
- Royal Perth (WA)
- Liverpool (NSW)
Activated sites are recruiting, with all six patients dosed to date recruited at the two longest-activated sites. Separately, the company states that five patients have been recruited and dosed across two sites.
Nyrada expects the recruitment rate to increase with the recent activation of Liverpool, Royal Perth and Northern Hospitals.
Further sites and 24/7 screening
Nyrada expects to activate three additional sites by the end of November 2026, expanding the network to eight. These sites are progressing through start-up activities, which include obtaining internal governance approval, site initiation and staff training, and receipt of Xolatryp.
The company is also assessing additional sites in Australia, New Zealand, Singapore and Hong Kong to expand the trial network and support recruitment. Liverpool Hospital is exploring 24/7 recruitment, which would allow eligible patients presenting overnight and on weekends to be screened and recruited.
| Site status | Detail | Relevance for investors |
|---|---|---|
| Activated and screening | Five sites across NSW, WA and VIC | Nyrada expects the recruitment rate to increase |
| In start-up | Three further sites expected by end of November 2026 | Would expand the network to eight |
| Under assessment | Australia, New Zealand, Singapore, Hong Kong | Intended to support recruitment |
| 24/7 recruitment | Being explored at Liverpool Hospital | Would allow overnight and weekend screening |
What a Safety Review Committee means for Xolatryp investors
Xolatryp is a small-molecule inhibitor of TRPC3/6/7 channels, designed to limit excessive Ca²⁺ entry related to multiple disease pathologies. The Phase IIa trial is assessing its safety and preliminary efficacy in reducing cardiac reperfusion injury in patients with ST-Elevation Myocardial Infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
Ischemia-reperfusion injury following PCI has no approved therapies despite roughly 5 million procedures performed globally each year, and preclinical work showed up to 86% cardioprotection for Xolatryp.
Nyrada will hold SRC meetings after 8, 30, 60 and 90 patients have been dosed, and will update the market following each meeting. Recruitment continues throughout and is not paused pending SRC outcomes.
Each SRC meeting is expected to occur at least 14 business days after the last patient in the relevant tranche is dosed, allowing time for pharmacokinetic (PK) samples to be shipped for analysis and safety data to be compiled. PK data tracks how a drug moves through the body.
Once the eighth patient is dosed (randomised 4 Xolatryp : 4 placebo), Nyrada will have a complete blinded PK and safety dataset for review at the first SRC meeting.
PROTECT-MI is a randomised, double-blind, placebo-controlled study. Efficacy data will be available once the trial is completed and the data is unblinded.
What happens next for Nyrada
The announcement sets out the following forward milestones:
- Three further sites activated: expected by the end of November 2026, expanding the network to eight.
- First SRC meeting: after the eighth patient is dosed, and at least 14 business days after dosing, with a market update to follow.
- Further SRC meetings: after 30, 60 and 90 patients are dosed.
- Final patient dosed: projected for mid-2027.
- Preliminary results: anticipated in 2HCY2027, following the 30-day follow-up period and approximately 90 days for data cleaning and review.
- US IND submission for Xolatryp in STEMI myocardial ischemia reperfusion: targeted for 1HCY2027.
The IND target follows positive written feedback from the US Food and Drug Administration (FDA) on its pre-Investigational New Drug (pre-IND) meeting, announced on 13 October 2026. Preparation of the US IND package is continuing in parallel with PROTECT-MI recruitment.
The supportive FDA feedback covered the Phase IIa program without a thorough QT/QTc study, and the agency indicated that some additional nonclinical and stability information would be needed in the final IND package.
For investors, the update shows clinical and regulatory work advancing side by side. Nyrada states it will continue to update the market on site activations, recruitment milestones and other material developments as the trial advances.
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