17 Oct 2025

Guard Therapeutics to Present Late-Breaking Phase 2b POINTER Results at ASN Kidney Week 2025

Guard Therapeutics (publ) today announced that top-line results from the company’s Phase 2b POINTER study with the investigational drug candidate RMC-035 have been selected for oral presentation on November 6 as a Late-Breaking Clinical Trial at the scientific conference American Society of Nephrology (ASN) Kidney Week 2025 in Houston, TX, USA.

“We are proud that the POINTER study has been selected for late-breaking oral presentation at ASN Kidney Week, the most prestigious global meeting for kidney research, clinical care and education,” said Tobias Agervald, CEO of Guard Therapeutics. “This important recognition reflects the strong interest in RMC-035 and its potential to become the first therapy of its kind to prevent and treat kidney injury associated with open-heart surgery.”

The presentation is contingent upon the availability of the top-line results, which are expected just before the conference and will be communicated in a separate press release.

The late-breaking abstract, titled “POINTER: A Phase 2b, Randomized, Placebo-Controlled, Double-Blind Dose-Finding Clinical Study of RMC-035 in Participants at High Risk for Kidney Injury Following Cardiac Surgery” will be presented by Dr. Jay L. Koyner, MD, Director of the Inpatient Dialysis Unit and ICU Nephrology at the University of Chicago Medical Center, and Professor of Medicine at the University of Chicago, IL, USA.

“It is a great honor to present the top-line results from the Phase 2b POINTER study as a Late-Breaking Clinical Trial at ASN Kidney Week,” said Dr. Koyner. “Acute kidney injury and its long-term implications for adverse kidney outcomes remain a major unmet need in the perioperative setting, and I am excited to share the upcoming main results of this important study evaluating the potential of RMC-035 to protect kidney function in patients undergoing cardiac surgery.”

Presentation details:

Oral Abstract Session: Late-Breaking Research Orals – 1
Date/Time: Thursday, November 6, 2025 | 4:30 PM – 6:00 PM CT
Location: Grand Ballroom C, George R. Brown Convention Center, Houston, TX
Abstract Publication Number: TH-OR084
Presentation Slot: 4:30 PM – 4:42 PM CT

As previously communicated, Guard Therapeutics will also present two posters on new efficacy data from secondary analyses of the Phase 2a AKITA study at ASN Kidney Week 2025.

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

About the POINTER study

The POINTER study is a randomized, double-blind, placebo-controlled Phase 2b trial of RMC-035 designed to evaluate its efficacy and safety as a kidney-protective treatment in open-heart surgery, and to determine the optimal dosing regimen and target patient population ahead of a registrational Phase 3 study.

The study includes a total of 170 patients randomized to two RMC-035 dose groups (60 mg and 30 mg) and a control group (placebo) in a 2:2:3 allocation. The primary efficacy endpoint is the change in renal function (eGFR) from baseline to Day 90 after surgery. Major Adverse Kidney Events (MAKE) at Day 90 after surgery is a secondary efficacy endpoint, defined as death, dialysis, or ≥25% loss of eGFR compared with baseline.

Data from the two RMC-035 dose groups will be pooled and compared with placebo in the primary efficacy analyses. Baseline kidney function was used as a stratification factor to ensure that patients with and without chronic kidney disease were evenly distributed across all treatment arms.

Patient recruitment for the study was completed during the second quarter of 2025, and the overall study results are expected to be available in November.

About the indication – kidney injury in open-heart surgery

The company's lead candidate RMC-035 aims to counteract kidney injury that occurs in connection with open-heart surgery and ultimately to reduce the risk of an irreversible loss of kidney function and future end-stage renal disease that requires dialysis treatment or a kidney transplant.

Open-heart surgery using a heart-lung machine typically involves coronary artery bypass grafting (CABG), with or without concurrent heart valve or aortic root surgery. This procedure often leads to significant kidney damage, primarily due to ischemia-reperfusion injury, where blood flow and oxygen supply to the kidneys are reduced.

Another contributing factor is hemolysis, the breakdown of red blood cells, which releases harmful byproducts of hemoglobin that can damage the kidneys. Hemolysis occurs during extracorporeal blood circulation through the heart-lung machine, as well as following blood transfusions, which are commonly administered during the procedure. Additionally, the lack of oxygen and the effects of hemolysis often trigger a secondary inflammatory response, exacerbating kidney injury and increasing the risk of scarring and permanent loss of kidney function.

About RMC-035

The company’s lead candidate RMC-035 represents a completely new class of drugs (first-in-class) and consists of a recombinant and modified variant of the endogenous protein alpha-1-microglobulin. The investigational drug has the ability to protect cells and their mitochondria from damage caused by oxygen deprivation and elevated levels of the oxygen-binding and toxic protein heme. Favorable treatment effects of RMC-035 have been observed in several preclinical disease models. RMC-035 has a natural affinity for the kidneys and is primarily being developed as an intravenous kidney protective treatment for patients at high risk of developing acute kidney injury (AKI).

RMC-035 has obtained an Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for administration to patients in clinical studies. Additionally, RMC-035 has been granted Fast Track Designation by the FDA to reduce the risk of irreversible loss of kidney function, the need for dialysis treatment, or death after open-heart surgery in patients at elevated risk of AKI.

Results from the Phase 2 AKITA study, which enrolled 177 patients, demonstrated a statistically significant and clinically relevant beneficial effect of RMC-035 compared with placebo on long-term kidney outcomes in this patient population. Based on these results, a subsequent Phase 2b study, POINTER, was initiated.

In addition to its evaluation in open-heart surgery, RMC-035 has also been assessed in a Phase 1b clinical study in patients undergoing kidney transplantation.

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Press release

Guard Therapeutics to Present Late-Breaking Phase 2b POINTER Results at ASN Kidney Week 2025