OUR APPROACH
Designed Around What the AKI Field Has Taught Us
MARY1 and its clinical strategy are built on a clear reading of why acute kidney injury has resisted clinical translation — and a disciplined plan to address each of those challenges directly.
THE DEVELOPMENT CHALLENGE
Clinical programs in CSA-AKI have consistently failed to demonstrate efficacy in humans. The reasons are multifactorial — mechanistic, translational, and endpoint-related. What the field has established is how difficult it is to prove benefit in this setting without confirmed target engagement in the kidney and recovery endpoints that can be attributed to mechanism.
CSA-AKI remains the most interpretable setting to change this. A predictable, time-anchored injury window. A defined, risk-enriched patient population. Serial plasma and urine sampling. And recovery endpoints that now carry direct payer accountability under CMS TEAM.
The opportunity is not to repeat what has been tried. It is to bring a mechanistically grounded recovery medicine into the setting most likely to produce a clean, attributable signal — and to confirm that signal at every step.
HOW MARY1 ADDRESSES EACH FAILURE POINT
Recovery and prevention biology. Most AKI programs commit to one moment – before injury, or after. MARY1 is designed to work in both windows, so the clinical path doesn’t depend on catching every patient at the same point in surgery.
MECHANISTIC
A confirmed causal mechanism. Most AKI programs work backward from the correlation. MARY1’s mechanism was proven causal before the clinical plan is built.
TRANSLATIONAL
Attribution built in, not retrofitted. Most AKI trials fail without confirmed target engagement in the kidney. Ours is designed to answer that at every dose, before the efficacy readout.
ENDPOINT RELATED
A gate, not just a result. Most AKI programs treat recovery data as something to report after the fact. MARY1’s recovery endpoints — creatinine and eGFR trajectory, dialysis avoidance, length of stay – are prespecified go/no-go criteria that decide whether the program earns its next stage.