Nyrada has moved its PROTECT-MI heart-attack trial into active recruitment, with four hospitals open and three patients dosed. The biotech also reported supportive US FDA feedback, encouraging preclinical oncology data and AU$13.72 million in cash after a AU$12 million placement.
- Four hospitals activated and three patients dosed in PROTECT-MI
- Trial network expected to reach eight sites by November
- FDA pre-IND feedback raised no major issues
- Xolatryp matched dexrazoxane in a preclinical cardioprotection study
- AU$13.72 million cash balance and AU$12 million placement commitment
PROTECT-MI moves from start-up into recruitment
Nyrada Inc. (ASX:NYR) has reached the first genuinely consequential stretch of its lead clinical program: four hospitals are now activated and three patients have been dosed in the PROTECT-MI Phase IIa trial testing Xolatryp in heart-attack patients undergoing angioplasty.
The trial began the quarter with one hospital active. Nepean Hospital in New South Wales and Sir Charles Gairdner Hospital in Western Australia have been joined by Northern Hospital in Victoria and Royal Perth Hospital. Nyrada expects four more sites to come online by the end of November, potentially doubling the network to eight hospitals.
That expansion matters because recruitment has so far been modest, with three patients enrolled across two sites. Nyrada says screening data show potentially eligible patients presenting outside the current 8:00am to 4:30pm weekday window, prompting work on extended coverage and possible weekend on-call arrangements. The company expects recruitment to accelerate as more experienced STEMI research centres begin screening.
The first Safety Review Committee assessment is triggered after eight patients have been dosed, split evenly between Xolatryp and placebo. It will include a complete blinded pharmacokinetic and safety dataset, but recruitment will continue while reviews occur. Efficacy results will not be available until the double-blind study is completed, with the final patient currently estimated to be dosed in mid-2027 and preliminary results expected in the third or fourth quarter of calendar 2027.
FDA feedback supports planned US filing
US regulatory progress has provided a second near-term milestone. Following the quarter, the FDA returned feedback on Nyrada’s pre-IND submission covering chemistry, manufacturing and controls, non-clinical, clinical and regulatory matters, with no major issues raised. The company says the feedback supports an IND submission for Xolatryp in the first half of 2027, while preparation continues alongside Australian recruitment.
The feedback builds on supportive FDA pathway feedback reported earlier this month. It is a favourable regulatory signal, but not an acceptance or approval of the future IND; that submission still has to be prepared and assessed.
Preclinical oncology data broaden Xolatryp’s case
Nyrada’s oncology program also produced encouraging, though still preclinical, evidence. In a five-week rodent study involving 12 animals per group, Xolatryp significantly protected cardiac function across four echocardiographic measures during repeated doxorubicin exposure. The effect appeared by week three, persisted through week five and was comparable in magnitude with dexrazoxane, the approved cardioprotective agent used as the positive control.
Blinded histopathology supported the functional result, with myocardial injury reduced from moderate to mild focal injury. Other measures were less definitive: cardiac troponin I was about 19% lower at week five and myocardial collagen content was numerically lower, but neither difference was statistically significant. Nyrada has begun designing a Phase Ib oncology trial, while a separate preclinical MCAO stroke study is being designed as a step towards a possible Phase IIa stroke trial.
Funding extends development runway
The quarter ended with AU$13.72 million in cash, up from AU$8.39 million at 30 June, after AU$6.875 million of placement proceeds arrived during the period. Operating cash outflow was AU$1.221 million, including AU$568,000 for research and development, AU$327,000 in staff costs and AU$411,000 in administration and corporate costs.
The broader financing package comprises AU$12 million placement funding, including AU$5.125 million committed by directors subject to CDI holder approval, plus a non-underwritten shareholder purchase plan targeting up to a further AU$2 million. The Appendix 4C calculates approximately 11.23 quarters of funding at the latest operating cash-burn rate, although that simple measure does not account for the cost of expanding clinical activity, the planned IND work or new oncology and stroke studies.
Nyrada also received a US composition-of-matter patent for Xolatryp and associated analogues, with a 20-year term from the September 2024 filing date. The immediate test is now operational rather than theoretical: whether a larger hospital network can convert the promising regulatory and preclinical backdrop into sustained patient recruitment, followed by clinical data strong enough to justify the next round of development.
Bottom Line?
The next hard evidence point is the first Safety Review Committee assessment after eight patients, while recruitment pace and completion of the planned US IND package will determine whether the current development timetable holds.
Questions in the middle?
- Can the expanded hospital network lift PROTECT-MI recruitment from three patients into the expected acceleration phase?
- Will the first eight-patient safety and pharmacokinetic review support continued progression without changes to the trial plan?
- How much additional cash will the US IND, oncology Phase Ib and stroke preclinical programs require beyond the current runway estimate?