Australian biotech Nyrada Inc (ASX: NYR) has reported encouraging pre-clinical results from its drug development program to treat patients with high cholesterol.
The company today told the market the results indicate the potential to develop a single pill treatment for hypercholesterolemia to replace expensive ongoing injections.
Nyrada has been conducting a study using healthy donor human lymphocytes (white blood cells) treated with the company’s PCSK9 inhibitor drug, NYX-PCSK9i.
When the body has too much low-density lipoprotein (LDL, also referred to as “bad” cholesterol) cholesterol, it can accumulate on artery walls, restricting blood flow and potentially lead to heart attack and stroke. PCSK9 is a naturally produced protein that plays a counter role in the regulation process.
According to pre-clinical results, the cells showed an increase in LDL receptor levels and demonstrated equivalency to marketed monoclonal PCSK9 antibody drugs, evolocumab and alirocumab.
The results were also confirmed both with and without the addition of statin, demonstrating the potential to develop a combined PCSK9-statin single pill treatment.
Current treatments for high cholesterol
According to Nyrada, an estimated 70% of individuals at risk of cardiovascular disease are unable to reach their target LDL cholesterol level using statin therapy alone.
Therefore, current treatments for high LDL cholesterol often comprise expensive and ongoing injections that have to be taken as separately to statins.
These drugs include evolocumab, branded as Repatha by Amgen, and alirocumab, which was developed under the name Praluent by Sanofi and Regeneron.
According to Nyrada, combined sales for Repatha and Praluent PCSK9 inhibitor injectables totalled more than US$900 million (A$1.29 billion) in the 2019 financial year.
Nyrada chief executive officer James Bonnar said having a drug candidate that works as well as the two market-leading monoclonal PSCK9 antibodies in a human cell model is a “huge achievement”.
“It represents a big step forward in our mission to develop the first-ever small molecule PCSK9 inhibitor to treat high cholesterol and provide a compelling cost-competitive and convenient treatment alternative to Repatha and Praluent,” he said.
Nyrada Scientific Advisory Board member Professor Gilles Lambert said the pre-clinical results mark an exciting scientific milestone for the company by indicating the potential to provide a more convenient option for patients than regular injections.
“Results occur both with and without a statin being present, opening up the potential for Nyrada’s drug to be given on its own, or in combination with statin therapy,” he added.
Nryada had $6.1 million of cash in the bank at the end of the March quarter, while also actively pursuing a variety of non-dilutive funding and collaboration opportunities for the development of its product candidates.