– Reports Promising Early Data from Lead Clinical Program, JK07, for the Treatment of Heart Failure with Reduced Ejection Fraction –
– Initiates Enrollment in Second Cohort of JK07 Phase 1 Dose Escalation Study –
(Gaithersburg, MD) – March 7, 2022 – Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment, which was completed in the fourth quarter of 2021, will be used to advance the current pipeline, including continuation of an ongoing Phase 1b clinical trial and initiation of two additional Phase 1b clinical trials in 2022, and to further expand the pipeline through R&D.
“SalubrisBio is poised for a transformational year and I’m excited about the remarkable opportunities that lie ahead for us”, said Sam Murphy, Chief Executive Officer of SalubrisBio. “We are focused on advancing our programs and securing additional funding to progress the development of our portfolio of antibody fusion proteins and other complex biologics.”
Since its inception, SalubrisBio has built a drug discovery and development platform to address significant unmet medical needs in cardiovascular diseases, cancer and neurodegenerative diseases. The company has multiple assets in clinical/preclinical development and additional programs at the discovery stage. SalubrisBio’s lead asset, JK07, is an antibody-based NRG-1 fusion protein currently in Phase 1 trials to assess safety and tolerability and to explore activity in subjects with heart failure with reduced ejection fraction [HFrEF]. JK07 is the first bi-specific antibody globally to enter a clinical trial in a cardiovascular indication.
Results from Cohort 1 (n=5) of the ongoing randomized, double-blind, placebo-controlled, dose-escalation study demonstrate a favorable safety profile and promising signals of clinical benefit with JK07 over placebo, with observed maximum improvement in ejection fraction of up to 18% absolute over baseline (>50% relative improvement). Enrollment of Cohort 2 is ongoing and SalubrisBio plans to report additional data from this HFrEF trial at future medical meetings. In addition, the FDA has agreed on the initiation of a Phase 1 study of JK07 in heart failure with preserved ejection fraction [HFpEF], preparations for which are now underway.
“Heart failure patients experience a high burden of symptoms, and mortality remains high despite approved therapies.” said Dr. Wilson Tang, lead investigator and Research Director for the Section of Heart Failure and Cardiac Transplant Medicine at Cleveland Clinic. “The Cohort 1 data are positive and support the biological rationale for JK07. We are encouraged by JK07’s potential to address unmet needs in heart failure with reduced ejection fraction and look forward to better understanding its full potential in heart failure with preserved ejection fraction as well.”
JK07 HFrEF Phase 1 Study Design
The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study with five dose levels planned to assess the safety, tolerability, immunogenicity, pharmacokinetics, and exploratory efficacy of JK07 in subjects 18 to 80 years of age with HFrEF ≤40%. The size of the cohorts will range from five to nine subjects. Each cohort includes a single active unblinded sentinel subject receiving a single IV dose of JK07 prior to randomized single-dose administration of JK07 or placebo [3:1] in the remainder of the cohort.
For more information on the JK07 clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT04210375.
About Heart Failure
Heart failure affects an estimated 6.2 million Americans[i] and more than 64 million people worldwide[ii]. HFrEF and 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.
JK07 is a recombinant fusion protein consisting of a fully human immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor neuregulin [NRG-1]. NRG-1 is a clinically validated growth factor which has shown promising activity in HFrEF but also undesirable side effects. Research has shown that NRG-1 induces signaling through interaction with two different receptors – HER3 and HER4. The HER4 pathway appears to be responsible for the regenerative effects in the heart, while the HER3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1. By blocking HER3 signaling with an antibody fusion design, JK07 selectively stimulates the HER4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects.
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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[i] Centers for Disease Control and Prevention, Heart Failure, https://www.cdc.gov/heartdisease/heart_failure.htm, (accessed December 9, 2021).
[ii] Groenewegen, A., Rutter, F., Mosterd, A., & Hoes, A. (2020). Epidemiology of heart failure. European Journal of Heart Failure, 22(8), 1342-1356. https://doi.org/10.1002/ejhf.1858