On September 25, one of Arctic Aurora LifeScience’s biotech convictions, The Medicines Company, reported positive topline clinical trial results in two Phase 3 studies with the company’s RNA interference (RNAi) drug candidate inclisiran in patients with hypercholesterolemia, meaning levels of ‘bad’ blood cholesterol well above those considered healthy and with considerably elevated risk for severe cardiac disease. 

The first of the two reported studies was a confirmatory trial to a Phase 3 study that Medicines Company presented full data on at a medical conference earlier during the month. Among those results, the company disclosed that patients on the RNAi treatment on average reduced cholesterol levels by more than half compared to those who received placebo. Most of the patients in the study were simultaneously on a traditional cholesterol-lowering regimen like statins, and inclisiran still managed to produce substantial additional drops in blood cholesterol levels. In addition, treatment with inclisiran showed a clean safety profile and preliminary signs of improved cardiac health. 

While we have to wait for another medical conference in November for full data disclosure on the latest study, the company confirmed “efficacy, tolerability and safety that were at least as favorable” as the already reported study. The second study that is now completed with positive results included patients with a genetic disorder that results in high levels cholesterol. Since the first Phase 3 results were announced late August, Medicines Company shares have gone up by 44%.

RNAi drugs like inclisiran works by silencing the genetic origin of a protein in way such that the protein is not manufactured in the targeted cells. In this case inclisiran stops the production of a protein called PCSK9. Without it, clearance of cholesterol from the bloodstream in considerably increased. Inclisiran was originally developed by Alnylam Pharmaceuticals, one of the key pioneering companies behind RNAi. As Alnylam focuses on rare diseases with the first ever RNAi drug on market since 2018, they out-licensed inclisiran to The Medicines Company who was let to cater to a much larger disease population. In the US alone, approximately 100 million people have high cholesterol levels and the World Health Organization estimates that 2.6 million deaths annually around the world can be attributed to cardiovascular disease caused by hypercholesterolemia.

With one drug treatment on the market, inclisiran projected to be commercially available next year, and another of Alnylam’s rare disease programs expected to be filed for approval to regulatory authorities soon, RNAi has quickly become an established drug treatment modality. With more biotech companies filling up treatment pipelines with novel RNAi drugs, we expect even busier news flows around RNAi going forward.  

 

 

Arctic Aurora LifeScience is an equity fund investing in global biotechnology and pharmaceutical companies. The fund is run by former portfolio manager in the Swedish Governmental Pension Fund AP3, Ulrica Bjerke, as well as Dr. Torbjørn Bjerke, both with 20 years of experience from the market. Arctic Aurora LifeScience was launched in May 2016 with both hedged and un-hedged share classes.

Past performance in Arctic Aurora LifeScience is no guarantee for future returns. Future returns depend on the market, fund manager skill, fund risk level, costs, among others. Performance in the fund may at times be negative and may for this fund vary considerably within periods.