GAITHERSBURG, Md.--(
BUSINESS WIRE
)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive interim data from the Phase 2 trial of JK07 (RENEU-HF) in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). The objective of this pre-specified interim analysis was to assess the safety of multiple doses of JK07 at the 0.045 mg/kg dose prior to opening of the 0.09 mg/kg dose treatment arms. These interim results from the first 68 subjects randomized demonstrated a safe and tolerable profile at 0.045 mg/kg, clear and consistent target engagement with repeat administration, and positive preliminary signs of efficacy. Following the evaluation of the interim results, and in agreement with the Data Safety Monitoring Committee, the high dose of 0.09 mg/kg has opened for enrollment. JK07 is the first selective ErbB4 agonist to enter clinical development for heart failure.
RENEU-HF (
NCT06369298
) is a randomized, double-blind, placebo-controlled, multiple-dose trial designed to evaluate the safety and efficacy of JK07 in patients with HFrEF and HFpEF. The study is expected to enroll 282 subjects who will be randomly assigned (2:1) to receive multiple doses of JK07 or placebo. The primary endpoint for HFrEF is improvement in ejection fraction, and the primary endpoint for HFpEF is safety and tolerability.
As of the data cutoff, sixty-eight patients were enrolled. JK07 was safe and well tolerated with no meaningful differences in adverse event (AE) frequency and severity between active and placebo groups. Magnitude of target engagement was seen to be robust and consistent from the first to the last dose administered during the first six months of the study. Preliminary efficacy data show trends towards improvement at this early stage of the study. Primary endpoint analysis is planned to be presented in 2026.
“We are encouraged by the safety profile and early efficacy trends from this interim analysis of RENEU-HF,” said Shalabh Singhal, Chief Medical Officer of SalubrisBio. “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.”
About Heart Failure
Heart failure affects an estimated 6.7 million Americans
1
and more than 64 million people worldwide
2
. Heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) each affect over 3 million patients in the US alone. Heart failure is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death. In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly. JK07 is in development for the treatment of both HFrEF and HFpEF.
About JK07
JK07 is a recombinant antibody fusion protein consisting of an active polypeptide fragment of the human growth factor neuregulin [NRG-1] and a fully human immunoglobulin IgG1 monoclonal antibody targeting ErbB3. NRG-1 is a clinically validated growth factor that has shown promising activity in heart failure, but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – ErbB3 and ErbB4. The ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the ErbB3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.
About SalubrisBio
SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular disease and cancer. SalubrisBio was founded in August 2016 as a wholly-owned subsidiary of the China-based pharmaceutical company Shenzhen Salubris Pharmaceuticals Co. Ltd. Headquartered in the US, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment to innovation and expansion into the global market and retains the core philosophy of developing therapeutics for large patient populations with significant unmet needs.
_________________________
1
Centers for Disease Control and Prevention, Heart Failure,
https://www-cdc-gov.libproxy1.nus.edu.sg/heart-disease/about/heart-failure.html
, (accessed January 21, 2025).
2
Groenewegen, A., Rutter, F., Mosterd, A., & Hoes, A. (2020). Epidemiology of heart failure.
European Journal of Heart Failure,
22(8), 1342-1356.
https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/ejhf.1858
