Latest progress
Recently, Salubris Biotherapeutics, Inc. (hereinafter referred to as "Salubris Bio"), a subsidiary of Salubris, announced positive results from the completed Phase 1b study of JK07 in patients with HFrEF. The data were presented in an oral presentation session during the Heart Failure Society of America Annual Scientific Meeting 2023.
JK07 (China project code: SAL007), independently developed by Salubris, is an NRG-1 fusion antibody drug with global intellectual property rights. It is the first selective ErbB4 agonist to enter the clinical development stage in the field of heart failure. The proposed indications include HFrEF (heart failure with reduced ejection fraction) and HFpEF (heart failure with preserved ejection fraction).
This product is the first Sino-American innovative biologic drug from Salubris. The phase I clinical trials (HFrEF indication) have been carried out in both the United States and China at the same time. The Phase I clinical trial in China has completed the enrollment and unblinding of the two dose groups. The patient follow-up and data cleaning are being carried out. Salubris Bio plans to submit a Phase II clinical trial application for chronic heart failure (including HFrEF and HFpEF) to the FDA soon. It is expected to officially start Phase II clinical patient enrollment in the first half of 2024.
The positive data released this time demonstrated that JK07 shows a good safety profile and the early clinical effect, which further identifies a therapeutic safety window. A single dose of JK07 resulted in a meaningful improvement in left ventricular ejection fraction within 6 months, and this sustained response suggests that JK07 has the potential to improve functional capacity, quality of life, and long-term outcomes for the patients.
JK07, if successfully developed and approved for marketing, will provide patients with new drug options to meet unmet clinical needs.
Clinical trial related
The Phase Ib clinical trial of JK07 is a randomized, double-blind, placebo-controlled, dose-and escalation study. The trial has been completed with complete data.
The LVEF (left ventricular ejection fraction) changes in all doses of JK07 compared to placebo were summarized as follows:
|
|
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% |
|
Relative mean change from baseline at Day 135 |
-33% |
+5% |
+23% |
+43% |
|
Relative mean change from baseline at Day 180 |
+10% |
+7% |
+49% |
+31% |
JK07 has demonstrated ≥31% average improvement in LVEF at the mid and high dose levels through 6 months following a single dose. 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.
We will further evaluate the efficacy and safety of JK07 in patients with HFrEF and HFpEF in a multi-dose Phase II clinical trial.
