ROSgard (recombinant alpha-1-microglobulin) / Guard Therap - LARVOL DELTA

POINTER: A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=170 | Active, not recruiting | Sponsor: Guard Therapeutics AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Renal Disease

A Phase 2b Dose Finding Study to Assess the Efficacy of RMC-035 on Renal Function in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery (POINTER) (ERA 2025) - P2 | "In the completed AKITA trial, RMC-035 improved eGFR by day 90 vs placebo, and fewer patients treated with RMC-035 met the secondary MAKE90 endpoint. The eGFR benefit was more pronounced in the predefined subgroup of patients with lower preoperative eGFR (<60 mL/min/1.73 m²). Herein, we present the design of the Phase 2b POINTER trial, aimed at determining the optimal dosing regimen of RMC-035 and confirming its nephroprotective properties prior to a Phase 3 trial."

Clinical • P2b data • Surgery • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

POINTER: A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=161 | Recruiting | Sponsor: Guard Therapeutics AB | Trial primary completion date: Aug 2025 ➔ Oct 2025

Surgery • Trial primary completion date • Cardiovascular • Renal Disease • CST3

Assessing Pharmacokinetics and Safety of Therapeutic Alpha-1-Microglobulin in First-in-Human Kidney Transplantation: A Noncomparative Open-Label Multiple-Dose Phase 1b Study. (PubMed, Transplant Direct) - "RMC-035 is a modified version of alpha-1-microglobulin, an endogenous protein developed as a renoprotective agent...Safety and AE profiles were in line with expectations of the target population, and infusion-related reactions were short-lived and manageable. Dose-limiting toxicity signals were not observed."

Journal • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Transplantation

Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial. (PubMed, EClinicalMedicine) - P2 | "These results merit further investigation and should be interpreted with caution, as the study was not powered for these outcomes. Guard Therapeutics."

Journal • P2a data • Surgery • Acute Kidney Injury • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Nephrology • Renal Disease • Reperfusion Injury

POINTER: A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=161 | Recruiting | Sponsor: Guard Therapeutics AB | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Cardiovascular • Renal Disease • CST3

POINTER: A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=161 | Not yet recruiting | Sponsor: Guard Therapeutics AB

New P2 trial • Surgery • Cardiovascular • Renal Disease • CST3

Therapeutic alpha-1-microglobulin ameliorates kidney ischemia reperfusion injury. (PubMed, Am J Physiol Renal Physiol) - "RMC-035 also dampened IRI-associated inflammation and improved mitochondrial function shown by tubular autofluorescence. Taken together, the efficacy of RMC-035 is congruent with its targeted mechanism(s) and biodistribution profile and supports its further clinical evaluation as a novel kidney-protective therapy."

Journal • Cardiovascular • Inflammation • Renal Disease • Reperfusion Injury • HMOX1 • KIM1

A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Guard Therapeutics AB | Phase classification: P1b ➔ P1

Phase classification • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology

Results of a Randomized Placebo-Controlled Double-Blind Adaptive Phase 2 Study (AKITA) Evaluating RMC-035 for the Prevention of AKI in Patients Undergoing Cardiac Surgery (KIDNEY WEEK 2023) - "Conclusions will be shared after availability of top-line results, expected around September 20."

Clinical • Late-breaking abstract • P2 data • Surgery • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

AKITA: Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=177 | Terminated | Sponsor: Guard Therapeutics AB | N=268 ➔ 177 | Active, not recruiting ➔ Terminated; Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint

Enrollment change • Surgery • Trial termination • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • CST3

Recombinant Alpha-1-Microglobulin (RMC-035) to Prevent Acute Kidney Injury in Cardiac Surgery Patients: Phase 1b Evaluation of Safety and Pharmacokinetics. (PubMed, Kidney Int Rep) - "Observed RMC-035 plasma exposures were safe and in the range of expected pharmacological activity. Furthermore, urine biomarkers suggest reduced perioperative kidney cell injury, warranting further investigation of RMC-035 as a potential renoprotective treatment."

Clinical • Journal • P1 data • PK/PD data • Surgery • Acute Kidney Injury • Cardiovascular • Inflammation • Nephrology • Renal Disease

AKITA: Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery (clinicaltrials.gov) - P2 | N=268 | Active, not recruiting | Sponsor: Guard Therapeutics AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • CST3

Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial). (PubMed, BMJ Open) - P2 | "RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI)...Results of this study will be published in a peer-reviewed scientific journal. NCT05126303."

Journal • P2 data • Surgery • Acute Kidney Injury • Cardiovascular • Critical care • Nephrology • Renal Disease