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 updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction (HFrEF). The data were presented in a late breaking oral session during the annual congress of the European Society of Cardiology’s Heart Failure Association. JK07 is the first investigational antibody fusion protein and first selective ErbB4 agonist to enter clinical development for heart failure. Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans1.
Fourteen patients were randomized 3 to 1 (11 JK07 : 3 placebo), with five patients in each of the first two cohorts (0.03mg/kg and 0.09 mg/kg, respectively), and four in the third cohort (0.27 mg/kg). Single doses were administered intravenously and changes from baseline values of left ventricular EF were measured for each patient. Results from the study were presented by principal investigator Dr. W. H. Wilson Tang, Research Director and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine at the Cleveland Clinic.
Key findings include:
- Robust dose-dependent biomarker changes demonstrated target engagement at all dose levels.
- Meaningful changes in LVEF were observed across all dose groups in comparison with placebo:
|
Placebo |
0.03 mg/kg |
0.09 mg/kg |
0.27 mg/kg |
||||
Mean Baseline LVEF (absolute) |
31% |
34% |
28% |
25% |
||||
Relative mean change from baseline at Day 30 |
+4% |
+20% |
+19% |
+22% |
||||
Relative mean change from baseline at Day 60 |
-6% |
+14% |
+28% |
+50% |
||||
Relative mean change from baseline at Day 90 |
-19% |
+9% |
+27% |
+14% |
||||
- JK07 has been generally well-tolerated with most adverse events mild to moderate. Only one serious adverse event occurred (Grade 3), at the top dose level.
“Heart failure is a leading cause of morbidity and mortality in the US and globally. These new interim results demonstrate that JK07 achieved robust target engagement and encouraging signs of potential clinical benefit with a single administration,” said Sam Murphy, Chief Executive Officer of SalubrisBio. “The durable and sustained responses observed, coupled with a favorable safety profile, support further investigation of JK07 and we look forward to building upon these findings with the initiation of a Phase 2 trial later this year."
A double-blind, randomized, repeat-dose Phase 2 trial of JK07 in patients with HF is expected to initiate in the second half of 2023.
About Heart Failure
Heart failure affects an estimated 6.2 million Americans2 and more than 64 million people worldwide3. 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 fusion protein consisting of a fully human immunoglobulin IgG1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. 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, oncology, and neurodegenerative diseases. 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.
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1 https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure.
2 Centers for Disease Control and Prevention, Heart Failure, https://www.cdc.gov/heartdisease/heart_failure.htm, (accessed May 8, 2023).
3 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/doi/10.1002/ejhf.1858
