What Is JK07?
JK07 is an investigational drug currently being studied in clinical trials. It is a recombinant fusion protein, meaning it is engineered to combine specific biological components. Specifically, JK07 consists of a fully human antibody designed to target the epidermal growth factor receptor 3 (also known as ErbB3 or HER3). This antibody is fused with an active fragment of the human growth factor Neuregulin (NRG)-1b protein. This unique structure suggests that JK07 may work by modulating cell signaling pathways that are important for cell growth, repair, and function, particularly those involving the HER3 receptor. Clinical trials are evaluating JK07 for its potential use in treating various heart-related conditions. The drug is sponsored by Salubris Biotherapeutics Inc. A total of 4 trials have been conducted or are ongoing, with 2 currently recruiting participants and 1 already completed. These studies have collectively enrolled 326 participants, with the first trial beginning in late 2019 and the latest projected to conclude in late 2025.Uses and Conditions Under Study
JK07 is currently under investigation for its potential to treat several serious cardiovascular conditions. These conditions are primarily related to heart failure and pulmonary hypertension.-
Heart Failure: JK07 is being studied for both Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure With Reduced Ejection Fraction (HFrEF). Heart failure occurs when the heart cannot pump enough blood to meet the body's needs. In HFpEF, the heart muscle contracts normally but the ventricles do not relax properly, making it harder for the heart to fill with blood. In HFrEF, the heart muscle does not contract effectively, leading to reduced blood pumping. Given JK07's mechanism involving a growth factor and the HER3 receptor, it is thought that the drug may play a role in improving heart muscle function, promoting cardiac repair, or influencing the heart's ability to pump blood more efficiently. Multiple trials are evaluating JK07 for these forms of heart failure, including studies like NCT05421710 and NCT05421697.
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Group 2 Pulmonary Hypertension: This type of pulmonary hypertension is specifically caused by left-sided heart disease, which often includes various forms of heart failure. It involves abnormally high blood pressure in the arteries of the lungs. Since JK07 is being investigated for heart failure, its potential benefits in improving heart function could also indirectly help to alleviate the symptoms and progression of Group 2 Pulmonary Hypertension. At least 1 trial is exploring JK07 for this condition, such as NCT05421710.
Dosing
In clinical trials, JK07 has been studied in different forms to determine the most effective and safest way to administer the drug. The investigational dosage forms include JK07, JK07 high dose, and JK07 low dose. These variations allow researchers to evaluate how different amounts of the drug affect participants and the conditions being studied. The specific strengths (e.g., milligrams) for these doses and the exact method of administration are determined by the trial protocols. The goal of these studies is to identify the optimal dose that provides therapeutic benefits while minimizing potential side effects for patients with heart failure and pulmonary hypertension.Side Effects
In a clinical trial involving 11 patients treated with JK07, several side effects were observed at a rate of 9.1%, compared to 0.0% in patients receiving placebo. These events were:
- Bilateral shoulder pain (9.1% on JK07 vs 0.0% on placebo)
- Brachial neuritis of both upper extremities (9.1% on JK07 vs 0.0% on placebo)
- Change in vision (9.1% on JK07 vs 0.0% on placebo)
- Elevated creatinine (9.1% on JK07 vs 0.0% on placebo)
- Intermittent nausea (9.1% on JK07 vs 0.0% on placebo)
- Mild headache (9.1% on JK07 vs 0.0% on placebo)
- Neuropathy exacerbation (9.1% on JK07 vs 0.0% on placebo)
Clinical Trial Results
JK07 in Heart Failure with Reduced Ejection Fraction (HFrEF)
A Phase 1 study (NCT04210375) investigated JK07 in patients with heart failure with reduced ejection fraction (HFrEF). The study assessed pharmacokinetic properties, safety, and Left Ventricular Ejection Fraction (LVEF).
Left Ventricular Ejection Fraction (LVEF) values were observed across different dose cohorts and placebo. In Cohort 1, LVEF values ranged from 34% to 42.5%. Cohort 2 showed LVEF values between 28% and 38.7%. For Cohort 3, LVEF ranged from 25% to 32.3%. Patients receiving placebo had LVEF values ranging from 22% to 33.7%.
Regarding safety and tolerability, the study recorded treatment-emergent adverse events. In Cohort 1, 4 events were reported, with no severe events. Cohort 2 had 3 events, also with no severe events. Cohort 3 reported 8 events, including 1 severe event. The placebo group reported 2 events, with no severe events.
Pharmacokinetic analysis showed that exposure to JK07 increased with higher doses. The geometric mean AUC(0-last) values were 5310 h*ng/mL for Cohort 1, 34400 h*ng/mL for Cohort 2, and 139000 h*ng/mL for Cohort 3. Similarly, geometric mean Cmax values were 497 ng/mL for Cohort 1, 1680 ng/mL for Cohort 2, and 5170 ng/mL for Cohort 3. The half-life (t1/2) also increased with dose, ranging from 8.11 hours in Cohort 1 to 18.32 hours in Cohort 3.
Currently Recruiting Trials
Clinical trials are essential for developing new treatments, and JK07 is currently being investigated in studies for patients with heart failure. These trials aim to understand how JK07 works, its safety, and its potential benefits for people living with these conditions.
One ongoing study, NCT07221513, is a Phase 2a, open-label trial evaluating JK07 in patients with heart failure and a specific type of pulmonary hypertension. This study focuses on individuals aged 18 to 85 years who have been diagnosed with heart failure, specifically Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF), along with Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension. Researchers are assessing the safety, tolerability, and efficacy of a high dose of JK07. The trial plans to enroll at least 20 and up to approximately 30 participants.
Another significant study, NCT06369298, is a Phase 2, randomized, double-blind, placebo-controlled trial for patients with chronic heart failure. This study is designed to evaluate the safety, tolerability, and efficacy of JK07 in participants aged 18 to 85 years. It includes individuals with both Heart Failure with Reduced Ejection Fraction and Heart Failure with Preserved Ejection Fraction. Participants will receive either a low dose or a high dose of JK07, or a placebo, to help researchers understand the drug's effects. This trial aims to enroll approximately 282 participants across two cohorts.
Where to Participate
The clinical trials for JK07 are reaching across a wide geographic area, making participation accessible to many individuals. Studies are currently active in 24 states across 49 cities, with a total of 52 sites available for enrollment.
Top locations with multiple sites include:
- Birmingham, Alabama
- St Louis, Missouri
- Dallas, Texas
Other cities with active sites include Little Rock, Arkansas; Huntington Beach, California; Los Angeles, California; Orange, California; Pasadena, California; Santa Maria, California; and Stanford, California. To be eligible for these studies, participants must be between 18 and 85 years of age. All genders are welcome, but the trials are not open to healthy volunteers or children.
Development Timeline
The journey of JK07 began with its first clinical trial on December 24, 2019, marking the start of its development by Salubris Biotherapeutics Inc. Since then, Salubris Biotherapeutics Inc has consistently sponsored all four trials for JK07, driving its progression through the clinical phases.
Initially, JK07 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As development progressed, the focus expanded to address significant cardiovascular conditions. The drug has moved through two Phase 1 trials and is currently being investigated in two Phase 2 trials, with the latest trial expected to conclude by October 28, 2025. This expansion reflects a strategic shift towards addressing complex heart conditions, including Group 2 Pulmonary Hypertension, Heart Failure with Preserved Ejection Fraction (HFpEF), and Heart Failure with Reduced Ejection Fraction (HFrEF). To date, a total of 326 participants have been involved in the clinical development of JK07.