Salubris Biotherapeutics Announces Positive Interim Data from Phase 2 Trial of JK07 in Heart Failure
Salubris Biotherapeutics a clinical-stage biotechnology company focused on developing innovative biologic therapies, has announced promising interim data from its Phase 2 clinical trial of JK07 (RENEU-HF), a novel treatment aimed at improving outcomes in heart failure patients. The data revealed positive findings from the trial, which included patients with both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
This pre-specified interim analysis was designed to evaluate the safety profile of multiple doses of JK07 at the 0.045 mg/kg dose before progressing to higher doses, including the 0.09 mg/kg treatment arm. The initial results, based on the first 68 patients enrolled, showed that the drug was well tolerated, with no significant safety concerns. Additionally, the trial demonstrated robust and consistent target engagement upon repeat dosing, as well as early indications of efficacy. Based on these positive findings, and following a thorough review by the Data Safety Monitoring Committee, the study has advanced to the 0.09 mg/kg dose level, with enrollment now open for this higher dose.
A Breakthrough in Heart Failure Treatment
JK07 represents a potential breakthrough in heart failure treatment. It is the first selective ErbB4 agonist to be tested in clinical trials for heart failure, positioning it as a unique therapeutic approach in this challenging field. The RENEU-HF trial (NCT06369298) is a randomized, double-blind, placebo-controlled, multiple-dose study designed to assess both the safety and efficacy of JK07 in heart failure patients. The trial is expected to enroll 282 participants, who will be randomly assigned in a 2:1 ratio to receive either multiple doses of JK07 or a placebo.
The primary endpoint for patients with HFrEF is an improvement in ejection fraction (EF), a key measure of heart function. In contrast, for patients with HFpEF, the primary endpoint focuses on safety and tolerability. Ejection fraction is a critical marker of heart failure severity, with reduced EF indicating a weakened heart that struggles to pump blood efficiently. Given the current lack of effective treatments for both HFrEF and HFpEF, the success of JK07 could represent a significant step forward in the management of these conditions.
Safety and Tolerability: A Key Positive Outcome
As of the latest data cutoff, 68 patients had been enrolled in the RENEU-HF trial. Of these, some received the 0.045 mg/kg dose of JK07, while others were given a placebo. Importantly, the data indicated that JK07 was well tolerated by patients, with no meaningful differences in the frequency or severity of adverse events (AEs) between the active drug and placebo groups. This is a promising sign, as safety is a critical factor when developing new treatments for complex diseases such as heart failure, where patients are often dealing with multiple comorbidities.
The trial demonstrated that JK07 achieved robust and consistent target engagement, showing that the drug successfully interacted with its intended biological target. This engagement remained stable throughout the first six months of the study, from the first dose to the final dose administered. Consistent target engagement is vital for ensuring the drug is working as expected and increasing the likelihood that it will have a meaningful therapeutic effect.
Early Efficacy Trends Show Promise
While the study is still in its early stages, preliminary efficacy data are showing positive trends. Although it is too early to make definitive conclusions, the initial data indicate that JK07 may have a beneficial impact on heart failure patients, suggesting that the drug could improve heart function and potentially reduce the progression of heart failure. The trial’s primary endpoint analyses, which will provide a more comprehensive assessment of the drug’s efficacy, are scheduled for release in 2026.
Heart failure remains a major global health issue, with millions of patients suffering from this debilitating condition. HFrEF, in which the heart’s pumping ability is significantly reduced, and HFpEF, where the heart struggles to fill properly due to stiffness, are both difficult to treat effectively. Current treatment options, including medications and device-based therapies, are limited in their ability to reverse disease progression or significantly improve outcomes for many patients. As such, the potential for JK07 to improve both the quality of life and long-term outcomes for heart failure patients is an exciting development in the field of cardiovascular medicine.
Optimism for the Future of JK07
Salubris Bio’s Chief Medical Officer, Dr. Shalabh Singhal, expressed his enthusiasm for the interim findings, stating, “We are encouraged by the safety profile and early efficacy trends from this interim analysis of RENEU-HF. The data continue to suggest that JK07 has the potential to improve function and long-term outcomes in heart failure patients. We look forward to building on these promising findings and advancing a potential new treatment option that improves heart function and quality of life for heart failure patients.”
The company is optimistic that these promising early results will continue as the study progresses, potentially leading to a new treatment option for the millions of people suffering from heart failure. With both the HFrEF and HFpEF patient populations in need of better therapies, JK07 has the potential to make a significant impact in the field. Salubris Bio is committed to continuing the development of JK07, with the goal of bringing this promising therapy to market for patients in need.
A Comprehensive Trial Designed for Real-World Impact
The RENEU-HF trial is designed not only to assess the safety and efficacy of JK07 but also to explore the broader potential of selective ErbB4 agonists in treating complex cardiovascular diseases. ErbB4 is a protein that plays a key role in regulating various cellular processes, and recent research has suggested that targeting ErbB4 may offer a novel approach to modulating heart function. By selectively activating this pathway, JK07 could help restore balance in the heart’s cellular mechanisms, leading to improved outcomes for heart failure patients.
The trial’s design is also important because it includes both HFrEF and HFpEF patients. Traditionally, treatments for heart failure have been tailored primarily to HFrEF patients, as this form of heart failure is more commonly associated with reduced heart function. However, HFpEF has been gaining attention as a growing and equally challenging condition. With no current disease-modifying treatments for HFpEF, the potential to address both HFrEF and HFpEF with a single therapy adds significant value to the development of JK07.
A New Era for Heart Failure Therapy
Salubris Biotherapeutics’ announcement of positive interim data from the Phase 2 trial of JK07 is an encouraging step forward in the quest to find better treatments for heart failure. With its robust safety profile, consistent target engagement, and early signs of efficacy, JK07 shows great promise for both HFrEF and HFpEF patients. As the RENEU-HF trial continues, and with the high dose now open for enrollment, SalubrisBio is one step closer to potentially delivering a much-needed new therapeutic option for heart failure patients worldwide. The coming years will be crucial in determining whether JK07 can fulfill its potential and offer meaningful improvements in heart function and patient quality of life.
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