Nyrada announces positive results from early PCSK9 study

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Australian company Nyrada (ASX:NYR) has reported what it describes as "encouraging preclinical results" from its program to develop a small molecule oral cholesterol-lowering PCSK9 inhibitor.

Nyrada said its PCSK9 inhibitor (NYX-PCSK9i) showed an increase in LDL receptor (LDLR) levels akin to Amgen's PBS-listed REPATHA (evolocumab) and Sanofi's recommended but not yet listed PRALUENT (alirocumab).

REPATHA and PRALUENT are biologics delivered via subcutaneous injection. Nyrada's NYX-PCSK9i is a small molecule delivered orally. The company said it is looking to develop a combined PCSK9-statin single-pill treatment for high LDL cholesterol.

According to Professor Gilles Lambert, Nyrada scientific advisory board member, “Nyrada plans to develop an oral medication PCSK9 inhibitor for patients with high cholesterol giving them a more convenient option than regular injections.

"Today’s results demonstrate that our PCSK9 inhibitor works just as well as the FDA approved injectable medications, REPATHA and PRALUENT in this cell model, marking the achievement of an exciting scientific milestone for the company.

"What is also exciting is that 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.”

Nyrada CEO 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. This advance will also be welcomed by the 70% of patients at risk of cardiovascular disease who take a statin but are still unable to reach their target LDL cholesterol level, and those patients who are statin-intolerant.”

The company said, while additional testing as part of a development program will be required before NYX-PCSK9i progresses to human trials, it has a solid cash position and it actively pursuing a variety of non-dilutive funding and collaboration opportunities.