JK07 for Heart Failure

(RENEU-HF Trial)

Recruiting at 87 trial locations

Overseen By Amanda McEwen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Salubris Biotherapeutics Inc

Must be taking: Anticoagulants

Disqualifiers: Uncontrolled hypertension, Stroke, Syncope, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

282 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JK07 for individuals with heart failure. The goal is to assess the safety and effectiveness of JK07, focusing on different levels of heart function. Participants will receive either a placebo (inactive substance) or varying doses of JK07 through an IV. Suitable candidates have stable heart failure, experience symptoms such as shortness of breath or fatigue, and are already on heart failure medication. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants should have stable heart failure and be on optimal medical therapy. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that JK07 is likely to be safe for humans?

Research shows that JK07 appears safe. In earlier studies, participants tolerated both small and large doses of JK07 well. For instance, one study found that single doses of 0.03 and 0.09 mg/kg did not cause major problems for those involved. Another report noted that small doses were not only safe but also had clear effects on the intended target, prompting tests of higher doses.

These findings suggest that JK07 might be safe for people with heart failure. Participants should discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

JK07 is unique because it offers a potentially new approach to treating heart failure by being administered directly through intravenous infusion. Unlike standard treatments like ACE inhibitors, beta-blockers, or diuretics, which often target symptoms or blood pressure, JK07 might work at a different level or mechanism, potentially offering more direct and rapid effects on heart function. Researchers are excited because this delivery method could lead to faster and more precise treatment outcomes, offering hope for patients who need quick relief from heart failure symptoms.

What evidence suggests that JK07 might be an effective treatment for heart failure?

Research shows that JK07 may help treat heart failure. In earlier studies, researchers tested JK07 on patients whose hearts were not pumping well. The results suggested that JK07 could improve heart function. Data from these studies showed possible improvements in heart performance and overall health. While more research is needed, the initial findings are promising for those with heart failure. Participants in this trial will receive either a low dose or high dose of JK07, or a placebo, to further evaluate its effectiveness. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with heart failure. It's split into two groups: one with severely reduced pumping function (ejection fraction ≤ 40%) and another with moderately reduced or preserved function (>40% to ≤65%). Participants will be randomly given either a low or high dose of JK07, or a placebo.

Inclusion Criteria

Screening hemoglobin ≥ 9.0 g/dL

I have mild to moderate heart failure.

My heart's pumping ability is reduced (LVEF ≤ 40%).

Exclusion Criteria

I have used a breathing aid machine in the last 4 weeks, but not for sleep issues.

Sustained systolic BP < 90 mmHg and/or diastolic BP < 50 mmHg on at least 3 consecutive readings

I have not received IV inotropes or vasopressors in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of JK07 or placebo administered by intravenous infusion

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JK07

Trial Overview The study tests the safety and effectiveness of different doses of JK07 compared to a placebo in improving heart failure symptoms. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug versus placebo during the trial.

How Is the Trial Designed?

Group I: JK07 low dose Active Control 1 Intervention

JK07 administered by intravenous (IV) infusion

Group II: JK07 high dose Active Control 1 Intervention

JK07 administered by intravenous (IV) infusion

Group III: Placebo Placebo Group 1 Intervention

Placebo administered by intravenous (IV) infusion

Who Is Running the Clinical Trial?

Salubris Biotherapeutics Inc

Lead Sponsor

Trials

5

Recruited

710+

Published Research Related to This Trial

Heart failure affects around 5 million people in the U.S. and is linked to significant mortality, highlighting the urgent need for new treatment strategies.

Research indicates that inhibiting or deleting the PKCα gene in animal models shows promising protective effects against heart failure, suggesting that PKCα could be a valuable therapeutic target for future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein kinase Cα as a heart failure therapeutic target. Liu, Q., Molkentin, JD.[2021]

Empagliflozin, originally developed for type 2 diabetes, has been shown to significantly reduce the risk of cardiovascular death and hospitalization for heart failure in patients with symptomatic chronic heart failure, regardless of their left ventricular ejection fraction, based on pivotal phase III trials.

The treatment not only improved cardiovascular outcomes but also enhanced health-related quality of life and was well tolerated, with a safety profile similar to that observed in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin: A Review in Symptomatic Chronic Heart Failure. Frampton, JE.[2022]

In the HEAAL trial involving patients with heart failure and reduced left ventricular ejection fraction (HFrEF), common adverse events (AEs) like kidney impairment, hyperkalaemia, and hypotension were more likely in older patients and those taking aldosterone blockers, highlighting the need for careful monitoring in these groups.

Experiencing AEs such as kidney impairment or hyperkalaemia significantly increased the risk of death, indicating that while the overall risk of severe AEs is low, identifying and monitoring at-risk patients is crucial for improving safety during treatment with angiotensin receptor blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting adverse events during angiotensin receptor blocker treatment in heart failure: results from the HEAAL trial. Kiernan, MS., Wentworth, D., Francis, G., et al.[2015]

A phase II clinical trial is underway to evaluate the efficacy of anakinra, an IL-1 receptor antagonist, in improving peak oxygen consumption in 102 patients with acute decompensated heart failure and systemic inflammation over 24 weeks.

The trial aims to provide insights into how anakinra affects not only exercise capacity but also other heart function parameters and quality of life, potentially offering a novel treatment strategy for heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. Van Tassell, B., Mihalick, V., Thomas, G., et al.[2023]

GRK2 plays a crucial role in heart failure by regulating β-adrenergic receptors and other protective signaling pathways, and its elevated levels can lead to cardiac dysfunction.

Inhibition or genetic deletion of GRK2 in animal models has shown promise in protecting the heart from adverse remodeling and dysfunction, highlighting it as a potential therapeutic target for heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GRK2 as a therapeutic target for heart failure. Cannavo, A., Komici, K., Bencivenga, L., et al.[2019]

A network meta-analysis of 91 trials involving 171,253 participants found that sodium-glucose co-transporters 2 (SGLT2) inhibitors have the lowest risk of heart failure compared to other anti-diabetic medications, with a significant reduction in heart failure events.

SGLT2 inhibitors were shown to be significantly more effective than insulin, dipeptidyl peptidase 4 inhibitors, glucagon-like peptide-1 receptor agonists, and thiazolidinediones in reducing heart failure risk, even among patients with existing heart failure or those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative outcomes of heart failure among existent classes of anti-diabetic agents: a network meta-analysis of 171,253 participants from 91 randomized controlled trials. Yang, DY., He, X., Liang, HW., et al.[2020]

In heart failure, chronic activation of the sympathetic nervous system leads to β-adrenergic receptor (βAR) dysfunction, primarily driven by the up-regulation of GPCR kinase 2 (GRK2), which negatively impacts heart function.

Targeting GRK2, particularly with the inhibitor peptide βARKct, has shown promise in improving heart function and structure in various animal models of heart failure, suggesting a potential new therapeutic strategy alongside existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting cardiac β-adrenergic signaling via GRK2 inhibition for heart failure therapy. Cannavo, A., Liccardo, D., Koch, WJ.[2022]

Interleukin-1 blockade shows promise as a potential anti-inflammatory treatment for heart failure, with early phase clinical trials indicating favorable safety and efficacy in reducing inflammation and improving heart function.

Despite these encouraging results, further large-scale clinical trials are necessary to confirm the effectiveness and safety of interleukin-1 blockade specifically for patients with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interleukin-1 Inhibition for the Prevention and Treatment of Heart Failure. Jafree, E., Del Buono, MG., Canada, JM., et al.[2023]

The incidence of heart failure with preserved ejection fraction (HFpEF) is likely increasing due to the lack of effective treatments, while heart failure with reduced ejection fraction (HFrEF) has better management options according to the 2021 European Society of Cardiology guidelines.

Current treatments targeting the Renin-Angiotensin-Aldosterone System (RAAS) are ineffective for HFpEF patients, highlighting the need for new therapeutic alternatives, such as drugs that stimulate the non-classic RAAS or emerging classes like SGLT2 inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future therapeutic perspective in chronic heart failure. Mascolo, A., di Mauro, G., Cappetta, D., et al.[2022]

In an 8-week study involving 63 patients with chronic heart failure and chronic kidney disease, a lower starting dose of patiromer (16.8 g/day) effectively maintained serum potassium levels within the target range while allowing for the safe initiation of spironolactone treatment.

Patiromer was well tolerated, with only a low incidence of adverse effects such as hypokalaemia (1.6%) and hypomagnesaemia (3.2%), demonstrating its safety and efficacy in preventing hyperkalaemia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an individualized dose titration regimen of patiromer to prevent hyperkalaemia in patients with heart failure and chronic kidney disease. Pitt, B., Bushinsky, DA., Kitzman, DW., et al.[2021]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacbts.2025.101352

Single Ascending-Dose Study of Selective ErbB4 Agonist ... Fourteen participants with heart failure with reduced ejection fraction were randomized to receive JK07 or placebo in a phase 1, double-blind, ...

2. salubrisbio.com salubrisbio.com/2025/01/22/salubris-biotherapeutics-announces-positive-interim-data-from-the-phase-2-trial-of-jk07-in-heart-failure/

Salubris Biotherapeutics Announces Positive Interim Data ... “The data continue to suggest that JK07 has the potential to improve function and long-term outcomes in heart failure patients. We look forward ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04210375

Study of JK07 in Subjects With Heart Failure With Reduced ... This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study to assess the safety, tolerability, immunogenicity, PK, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06369298

Study of JK07 in Patients With Chronic Heart Failure This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in ...

5. salubrisbio.com salubrisbio.com/2025/09/30/salubris-biotherapeutics-provides-updates-on-jk07-and-jk06-clinical-programs/

Salubris Biotherapeutics Provides Updates on JK07 and ... The primary endpoint of the study for the HFrEF cohort is change in left ventricular ejection fraction (LVEF) at 26 weeks. The HFrEF cohort ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1071916423008485

Final Analysis Of Safety And Exploratory Echo Data In A ... Single dose administration of 0.03 and 0.09 mg/kg JK07 was safe and well tolerated. Changes in LVEF and target engagement data suggest that JK07 selectively ...