Recently, Salubris announced that its subsidiary Salubris Biotherapeutics, Inc. (SalubrisBio) 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).
JK07 (Recombinant Human Neuregulin 1 (NRG-1) -Anti-HER3 Antibody fusion protein) as an NRG-1 fusion protein with global proprietary, is the first selective ErbB4 agonist [1] to enter clinical development stage for heart failure including HFrEF and 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 the opening of the 0.09 mg/kg dose treatment arms. According to the protocol "descriptive (no formal statistical test) interim analysis will be conducted". Following the evaluation of the interim results, the high dose of 0.09 mg/kg has opened for enrollment.
The phase 2 trial of JK07 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. These interim results from the first 68 subjects randomized demonstrated a safe and tolerable profile at 0.045 mg/kg, with no meaningful differences in adverse event (AE) frequency and severity between active and placebo groups, and positive preliminary signs of efficacy.
The successful launch of JK07 will provide patients with more options to meet unmet clinical needs
丨About NRG-1
NRG-1 is a group of proteins containing the epidermoid growth factor domain, which regulates cell growth and differentiation by activating tyrosine kinase protein receptors (HER3, HER4), and plays an important role in the normal development and function of the nervous system and heart. The unique molecular design of JK07 solves the limitations of recombinant NRG-1 protein therapy, blocks the function of HER3 receptor without affecting the activation of HER4, and greatly improves the druggability and safety of the product.
丨About heart failure
Heart failure is the final stage of various heart diseases, which has the characteristics of high morbidity and high mortality. It has become an important public health problem affecting the health of residents. Based on the level of left ventricular ejection fraction (LVEF) examined by echocardiography at the time of the patient's initial evaluation, heart failure can be divided into three basic types: "heart failure with reduced ejection fraction (HFrEF)", "heart failure with mildly reduced ejection fraction (HFmrEF)", and "heart failure with preserved ejection fraction (HFpEF)" [2].
References:
[1]The announcement of Shenzhen Salubris Pharmaceutical Co., Ltd. on JK07 overseas clinical trial progress.
[2] National Heart Failure Guidelines 2023.
Statement:
1. The purpose of this material is to provide relevant knowledge in the field of disease, improve the level of disease awareness, and non-advertising use.
2. The information in this document is for reference only. Please follow the advice or guidance of your doctor or other health care professional.
About Salubris
Shenzhen Salubris Shenzhen Salubris Pharmaceutical Co., LTD., founded in 1998 and listed in Shenzhen Stock Exchange in 2009 (Stock code: 002294), is an innovation-driven pharmaceutical enterprise based in China, facing the world and integrating research, production and marketing. The company has the entire chain of innovative drug research and development capabilities, focusing on cardiovascular and cerebrovascular diseases, diabetes, cancer, osteoporosis and chronic kidney disease and other chronic diseases; There are five innovative drug research and development centers in the world, which form an innovation platform mainly for small molecules, biologics, siRNA small nucleic acid and gene editing therapy, and medical devices, and develop innovative products with clinical value. The company continues to improve the accessibility of medicines, and its products cover many countries and regions in Europe, Asia, Africa, North America and South America, benefiting patients around the world.
