Recently, Salubris announced that JK07 (for the treatment of HFrEF) independently developed by its subsidiary, Salubris Biotherapeutics,Inc. (SalubrisBio) in the US, has obtained positive interim data from the phase 1b trial in the US.
JK07 is Salubris’ first China-US dual registration innovative biologics. The data obtained from the phase 1b trial in HFrEF patients showed that compared to the placebo group, JK07 presented good safety and potential clinical benefit. In addition, JK07 for the treatment of HFpEF has been approved to conduct phase 1 trial in US and China.
In the future, Salubris will continue innovation-driven research, develop more innovative and good drugs, and provide more medical options for patients with chronic diseases.
Sam Murphy（SalubrisBio CEO）
"JK07’s antibody-fusion design is demonstrating its potential to deliver the durable therapeutic effect of neuregulin, without the associated toxicity, to regenerate heart function and restore quality of life for heart failure patients.
The consistent, dose-dependent trends we’re observing in EF following a single dose, in conjunction with a favorable safety profile and concordant changes in established biomarkers, are highly encouraging. We look forward to further results from our third cohort and beyond. We are also excited to start recruiting patients for the first clinical trial with our IL15-CTLA4 antibody fusion, JK08, and we expect to share initial data in 2023."
Clinical data
The study cohort
Note: Enrollment in cohort 3 is ongoing
The phase 1 trial of JK07 is a randomized, double-blind, placebo-controlled, dose-escalation study. The interim analysis of this phase Ib data includes eleven NYHA II/III subjects across three single-ascending dose cohorts. Following completion of enrollment in the first two cohorts, administration of JK07 led to dose-dependent improvements in LVEF, with an average improvement of 30% observed at day (D) 90 in Cohort 2 (0.09mg/kg). The unblinded sentinel subject in Cohort 3 (0.27mg/kg) has shown a 70% improvement from baseline at D30 (the absolute improvement from 22% to 38%).
Note: n=4 and n=1 reference table 1 the study cohort
In contrast, placebo subjects (n=2) showed a 4% average improvement in EF at D30 and a decline of 14% on D90.
Moreover, dose-dependent increases in biomarker surrogates of target engagement were observed in each JK07-treated subject across the three cohorts, indicating that target engagement has not yet been saturated. JK07 has been generally well-tolerated in the study, with no serious adverse events (SAEs) reported to date.
The data showed that JK07 Cohort 2 EF improvement is comparable to similar drug at the same dose (dose converted), except that no dose-limiting toxicity was observed with JK07. JK07 Cohort 3, therefore, represents the potential for new levels of activity not seen before in neuregulin clinical studies.
Reference
①Lenihan et al. A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure. JACC Basic Transl Sci. 2016 Dec 26;1(7):576-586.
