PROTECT-MI trial expands to four active sites as FDA gives Xolatryp pathway the nod
Nyrada (ASX:NYR) has activated four sites for its PROTECT-MI Phase IIa clinical trial and received positive written FDA feedback on its Xolatryp pre-IND meeting request. The update was issued on 16 October 2026, while the FDA feedback was first announced on 13 October 2026.
Key points from the update:
- 4 sites activated (Nepean, Sir Charles Gairdner, Northern and Royal Perth Hospitals)
- 8 sites expected by the end of November 2026
- 3 patients recruited to date across two sites
- Final patient dosing projected for mid-2027, with preliminary results anticipated in 2HCY2027
- US IND submission targeted for 1HCY2027
The trial is scaling up while a US regulatory pathway is being progressed in parallel.
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Site network set to double to eight by November 2026
Experienced STEMI centres come online
Northern Hospital (VIC) and Royal Perth Hospital (WA), both described as highly experienced STEMI research centres, have now been activated. They join Nepean Hospital (NSW) and Sir Charles Gairdner Hospital (WA), and all four are screening patients.
Nyrada expects four further sites, including Liverpool Hospital (NSW), to be activated by the end of November 2026: two by the end of October and two by the end of November. That would double the network to eight sites.
The company is also assessing additional sites in Australia, New Zealand, Singapore and Hong Kong to expand the trial network and support recruitment.
What “activated” means
A site is considered activated once all key start-up activities are complete. These include:
- Governance approvals
- Site initiation
- Staff training
- Receipt of Xolatryp and placebo
For investors tracking recruitment, the pace of site activation matters. Recruitment in multicentre clinical trials (studies run across several hospitals at once) typically follows an S-shaped curve: slow while sites are activating, then accelerating as sites come online and recruit their first patients.
Recruitment outlook
Three patients have been recruited to date across two sites. According to the company, early recruitment has been slower than anticipated, which it says reflects the initial phase of site activation, with half of the currently active sites only recently opened.
Company expectation
Nyrada expects recruitment “to accelerate over the coming months.”
The company points to two drivers. Analysis of screening data from active sites shows potentially eligible patients are presenting outside core screening hours of 8:00am to 4:30pm, Monday through Friday, and Nyrada is working with sites to extend screening coverage. Sites with capacity may also introduce dedicated PROTECT-MI weekend on-call arrangements as teams become familiar with the protocol.
| Driver | What’s happening | Investor relevance |
|---|---|---|
| Site network expansion | Network expected to double from 4 to 8 sites by the end of November 2026, including experienced STEMI research centres | Nyrada expects PROTECT-MI to move into the acceleration phase of the typical S-shaped recruitment curve |
| Extended screening hours | Potentially eligible patients are presenting outside 8:00am to 4:30pm Monday to Friday; Nyrada is working with sites to extend coverage | Sites with capacity may introduce dedicated weekend on-call arrangements |
Safety reviews and the path to results
Nyrada will hold Safety Review Committee (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. 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, so efficacy data will be available only once the trial is completed and the data is unblinded.
The projected timeline to results is:
- Final patient dosed in mid-2027
- 30-day follow-up period
- Approximately 90 days for data cleaning and review
- Preliminary results anticipated in 2HCY2027
Regular SRC updates are expected to provide a steady flow of milestones ahead of the final results. Nyrada said it remains confident in this timeline.
FDA feedback supports the US IND pathway for Xolatryp
The US Food and Drug Administration (FDA) provided feedback across chemistry, manufacturing and controls (CMC), nonclinical, clinical and regulatory aspects of the development program. It was supportive of Nyrada’s proposed development pathway with no major issues identified.
According to the company, this feedback supports progression towards submission of a US Investigational New Drug (IND) application for Xolatryp® in 1HCY2027, a key milestone in its development as a treatment for reperfusion injury in patients suffering a heart attack.
The pre-IND feedback also indicated the FDA would accept the Phase IIa program proceeding without a thorough QT/QTc study, and flagged that some additional nonclinical and stability information will be needed in the final IND package.
Nyrada’s current priority remains recruitment into PROTECT-MI, with preparation of the IND package continuing in parallel. Together, the written FDA feedback and the expanding site network address two separate areas of the company’s development plan.
The US regulatory work is supported by a US composition of matter patent for Xolatryp, which runs 20 years from the September 2024 filing date and underpins the IP position ahead of any licensing or partnership discussions.
Xolatryp is a small-molecule inhibitor of TRPC3/6/7 channels. A Phase I trial has been successfully completed, and a Phase IIa trial has commenced in patients with ST-Elevation Myocardial Infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
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