Recently, Salubris announced that the clinical trial application for its self-developed innovative small molecule drug SAL0140 tablets (project code: SAL0140) has been officially accepted by the National Medical Products Administration (NMPA). The intended indications for SAL0140 include various forms of uncontrolled hypertension (including refractory hypertension).
Targeting Aldosterone Synthesis Mechanism, Breaking Through Traditional Treatment Limitations
SAL0140 is an aldosterone synthase inhibitor developed by Salubris based on its own intellectual property. Aldosterone is the most important mineralocorticoid in the human body, maintaining fluid and electrolyte balance by activating the mineralocorticoid receptor (MR), and directly involved in target organ damage in various cardiovascular and renal diseases. Research indicates that aldosterone not only causes damage to end organs through MR-mediated genomic signaling pathways but may also induce damage through non-MR-mediated non-genomic signaling pathways. The aldosterone synthase inhibitors have the potential to reduce blood pressure while alleviating end-organ damage under both genomic and non-genomic effects by inhibiting aldosterone synthesis, showing promising development potential [1].
Impressive Preclinical Data, Significant Blood Pressure Reduction
Preclinical studies have shown that SAL0140 selectively inhibits the activity of aldosterone synthase, thereby inhibiting aldosterone synthesis without affecting cortisol levels. In hypertensive monkey models, SAL0140 significantly inhibits aldosterone production, achieving stable blood pressure control with once-daily administration [1].
Addressing Unmet Clinical Needs and Enriching the Chronic Disease Pipeline
In recent years, there has been a noticeable improvement in the awareness, treatment, and control rates of hypertension among patients in China. However, these rates remain relatively low, at 51.6%, 45.8%, and 16.8% respectively [2]. Poor blood pressure control can accelerate the occurrence and progression of cardiovascular and cerebrovascular events. Despite the availability of various treatment options, some patients still struggle with uncontrolled blood pressure, making resistant hypertension a significant challenge in the field of hypertension treatment.
If SAL0140 is successfully developed and approved for market release, it is expected to provide targeted new treatment options for hypertension patients in more specialized areas, addressing unmet clinical needs and further enriching Salubris' innovative product pipeline in the chronic disease sector.
丨About Resistant Hypertension
Resistant hypertension is diagnosed when, despite intensive lifestyle interventions and the concurrent use of three different types of antihypertensive medications (including a thiazide diuretic) at maximum or maximally tolerated doses for at least four weeks, the office blood pressure remains ≥140/90 mmHg, the 24-hour average ambulatory blood pressure is ≥130/80 mmHg, or the average home blood pressure is ≥135/85 mmHg. Alternatively, resistant hypertension is also diagnosed if blood pressure control is only achieved with the use of four or more antihypertensive medications [2].
References:
[1] Announcement on the Acceptance of the Clinical Trial Application for SAL0140 by Shenzhen Salubris Pharmaceuticals Co., Ltd.
[2] Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revision).
Disclaimer:
1. The purpose of this material is to provide knowledge in the field of disease, to improve the level of disease awareness, and is not intended for advertising purposes.
2. The information contained in this material is for reference only. Please follow the advice or guidance of a doctor or other healthcare professional.
About 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.
