JK07 for Heart Failure and Pulmonary Hypertension
(RENEU-PH Trial)
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 and pulmonary hypertension (high blood pressure in the lungs). Researchers aim to determine if JK07 is safe and effective when administered in high doses through an IV. Candidates with heart failure exhibiting moderate symptoms and a diagnosis of pulmonary hypertension may be suitable for participation. Participants will receive JK07 and undergo close monitoring to assess their response to the treatment. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that JK07 is likely to be safe for humans?
Research has shown that JK07 has undergone testing in earlier studies for safety in people with heart failure. In these studies, patients received several doses of JK07, and the treatment was generally well-tolerated. No major safety issues were reported, suggesting that JK07 might be safe for humans. However, like any treatment, side effects may occur and can vary from person to person. Discussing potential risks with healthcare professionals before joining a trial is important.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for heart failure and pulmonary hypertension, which often include medications like ACE inhibitors, beta-blockers, or diuretics, JK07 is administered via intravenous infusion, potentially allowing for more direct and immediate effects on the cardiovascular system. Researchers are excited about JK07 because it targets specific pathways associated with heart failure and pulmonary hypertension differently than existing treatments, which could lead to improved efficacy and fewer side effects. This novel approach may help address unmet needs in patients who do not respond well to current therapies.
What evidence suggests that JK07 might be an effective treatment for heart failure and pulmonary hypertension?
Research shows that JK07 might help treat heart failure and high blood pressure in the lungs. In animal studies, JK07 improved heart function similarly to an existing treatment called NRG-1, enhancing the heart's pumping ability, which is crucial for those with heart failure. Early human trials have also shown promising results, with improvements in heart pumping efficiency, measured by left ventricular ejection fraction. These early findings suggest that JK07 could be a useful treatment for these conditions.12456
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 with heart failure and a specific type of pulmonary hypertension (cpcPH). They must have certain measurements indicating the severity of their condition, like mPAP ≥25 mmHg and PAWP ≥16 mmHg. Participants should be in NYHA Class II-III heart failure, with either reduced or preserved ejection fraction.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JK07 high dose via intravenous infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JK07
Trial Overview
The study is testing JK07's safety, tolerability, and effectiveness in patients with heart failure and cpcPH. It's an open-label Phase 2a trial where all enrolled participants will receive a high dose of JK07 over multiple doses.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
JK07 administered by intravenous (IV) infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Salubris Biotherapeutics Inc
Lead Sponsor
Citations
Study of JK07 in Patients With Heart Failure and WHO ...
This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of ...
2.
salubrisbio.com
salubrisbio.com/2025/09/30/salubris-biotherapeutics-provides-updates-on-jk07-and-jk06-clinical-programs/Salubris Biotherapeutics Provides Updates on JK07 and ...
Company initiated RENEU-PH, Phase 2a study of JK07 in patients with Group 2 pulmonary hypertension and heart failure. Phase 1 dose escalation ...
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 participants ...
4.
finance.yahoo.com
finance.yahoo.com/news/salubris-biotherapeutics-provides-updates-jk07-210000905.htmlSalubris 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 ...
Preclinical Evaluation of the Safety and Activity of JK07, A ...
... effective as NRG-1 in improving LVEF and symptoms. In a spontaneous heart failure model in rhesus macaques, JK07 treatment was comparable to ...
Phase 2 Study of JK07 in Chronic Heart Failure
The purpose of this study is assess the safety and effficacy of JK07 in Adults With Chronic Heart Failure.
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