Guard Therapeutics

“These additional analyses from the AKITA study further strengthen the evidence supporting RMC-035’s ability to protect kidney function in high-risk patients undergoing open-heart surgery,” said Tobias Agervald, CEO of Guard Therapeutics. “We are encouraged by these findings and look forward to the top-line results of the Phase 2b POINTER study, anticipated in early November.”
 
The new analyses address three aspects: first, whether the kidney-protective effect of RMC-035 at Day 90 is influenced by patients meeting the criteria for acute kidney injury (AKI) within three days of the surgical procedure; second, how RMC-035 affects the amount of albumin in urine, an important prognostic marker of kidney function; and third, what effect RMC-035 has on levels of important biomarkers of cellular injury in the kidney after surgery. In all cases, the results were favorable for RMC-035 compared with placebo.

The main results are summarized below:

• Consistent with the primary analysis demonstrating a statistically significant improvement in kidney function measured by estimated glomerular filtration rate (eGFR) with RMC-035 compared with placebo, the new analyses confirm favorable effects both in patients with and without signs of acute kidney injury (AKI) following surgery. At Day 90, the net difference in eGFR between RMC-035 and placebo was 5.5 mL/min/1.73 m² (90% confidence interval [CI] 1.7–9.4; P = 0.019) among those without AKI, and 4.9 mL/min/1.73 m² (90% CI 0.8–9.1; P = 0.056) among patients with AKI. This demonstrates the kidney-protective potential of RMC-035 irrespective of the acute injury phase.
• In patients with chronic kidney disease (baseline eGFR <60 mL/min/1.73 m²), treatment with RMC-035 significantly reduced albuminuria, measured as the urinary albumin-to-creatinine ratio (UACR), compared with placebo at Day 90. This is important since high UACR levels predict faster progression of chronic kidney disease and a greater risk of end-stage renal disease, while reductions in UACR are associated with better long-term outcomes. In this pre-specified subgroup, UACR decreased with RMC-035 (–34.1% [90% CI –58.8 to +5.5]) whereas it increased with placebo (+42.5% [90% CI –3.5 to +110.2]; geometric mean ratio [GMR] 0.42 [90% CI 0.24–0.76]; P = 0.020).
• Biomarker assessments reflecting post-operative tubular cell injury further supported a beneficial effect of RMC-035. At 24 hours, the increase in Kidney Injury Molecule-1 (KIM-1) was significantly attenuated in the RMC-035 group compared with placebo (GMR 0.66; 95% CI 0.50–0.88; P = 0.004). This effect was consistent across eGFR subgroups: baseline eGFR <60 mL/min/1.73 m² (GMR 0.60; 95% CI 0.38–0.96; P = 0.038) and baseline eGFR ≥60 mL/min/1.73 m² (GMR 0.70; 95% CI 0.49–0.99; P = 0.047). Addtionally, the absence of differences in post-operative Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels between treatment groups confirms that RMC-035 does not induce tubular cell harm, even at higher exposures.

Taken together, the new results reinforce the primary analyses of the AKITA study and provide additional insights into the underlying protective mechanisms of RMC-035.
 
As previously communicated, the new analyses will be presented in part as two separate posters at ASN Kidney Week, November 5–9, 2025, in Houston, TX, USA, as follows:

• Session Title: AKI: Epidemiology and Clinical Trials [PO0102-2]
• Session Date/Time: November 7, 2025, 10:00 AM – 12:00 PM local time
• Poster Board #: FR-PO0093 – Kidney Function Following Open-Chest Cardiac Surgery: Post Hoc Analysis of the AKITA Study
• Poster Board #: FR-PO0094 – Efficacy of RMC-035 in Reducing MAKE90 in Patients With and Without AKI After Cardiac Surgery: Post Hoc Analysis of the AKITA Study

For more information, please visit the ASN website: American Society of Nephrology | Kidney Week - Meeting Overview (2025)