Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving cardio-metabolic health, announced the completion of a $132 million Series B financing led by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG and existing investors Longitude Capital, Medicxi and RxCapital. This financing will further support clinical advancement of lead candidate HU6, a first-in-class Controlled Metabolic Accelerator (CMA) designed to treat cardio-metabolic disease by addressing obesity, a primary driver of disease.
“We have an exceptional group of investors who share our vision for bringing a new class of treatments to patients with obesity and cardio-metabolic disease,” said Allen Cunningham, President and CEO of Rivus Pharmaceuticals. “Following encouraging data from our Phase 2a clinical trial in patients with obesity, this financing enables us to advance development of HU6 and a pipeline of Controlled Metabolic Accelerators to address a range of cardio-metabolic conditions.”
“RA Capital is excited to lead this round to provide patients a differentiated approach to more effectively treat obesity and cardio-metabolic disease,” said Derek DiRocco, partner at RA Capital and new board director. “While there have been several recent clinical successes in the treatment of obesity, CMAs stand alone in their ability to demonstrate significant fat reduction while sparing muscle mass, a very desirable profile especially in patients with diabetic myopathy and sarcopenia.”
Nearly half of American adults are living with cardio-metabolic diseases, conditions that adversely impact a person’s health and quality of life. Obesity is a common driver of cardio-metabolic disease, yet weight loss via lifestyle modification remains challenging for many patients. Rivus’ CMAs are designed to safely harness mitochondrial uncoupling, a natural process that regulates and dissipates energy, to selectively reduce fat throughout the body. While numerous approaches are being explored to reduce energy intake in obesity, CMAs are unique in their focus on increasing energy expenditure, thereby avoiding loss of skeletal muscle mass as seen with other therapeutics.
Earlier this year, Rivus released data from a Phase 2a metabolic study investigating lead candidate HU6 in obese participants. The study provided proof of concept validation that CMAs have the potential to treat not only obesity, but a range of cardio-metabolic diseases including heart failure with preserved ejection fraction (HFpEF), type 2 diabetes and Nonalcoholic fatty liver disease (NAFLD)/Nonalcoholic steatohepatitis (NASH).
Key findings of the 8-week study include:
- HU6 demonstrated significant reductions in liver, visceral, and total body fat while conserving skeletal muscle mass, all without changes in diet or exercise. Weight loss was amplified in patients with elevated HbA1c.
- Reductions in liver fat were 30%-40% across doses and will be further quantified in a longer duration Phase 2b obesity study.
- Patients treated with HU6 saw improvement in key cardiovascular and metabolic health indicators including glycemic control, glycated albumin and HbA1c, reduction in blood pressure and inflammatory markers.
- Both Phase 1 and 2a metabolic data showed that HU6 was well tolerated across all dose levels with no Serious Adverse Events (SAEs) or deaths reported.
Rivus recently initiated a Phase 2a study in obese participants with heart failure with preserved ejection fraction (HFpEF) and plans to initiate a Phase 2b study in obesity, including a subset of obese participants with type 2 diabetes in 2023.