Nyrada one step closer to cholesterol pill, shares surge

Nyrada (ASX: NYR) has received “encouraging” results from a lab-based cholesterol-lowering study, for the drug it hopes to use to treat hypercholesterolemia — or high cholesterol.

The preclinical study used healthy donor human white blood cells, lymphocytes, and treated them with Nyrada’s PCSK9 inhibitor NYX-PCSK9i. The results showed an increase in LDL receptor (LDLR) levels and it worked as well as the evolocumab and alirocumab drugs already on the market.

Nyrada stock rose 71 per cent at the open on Monday morning to 30c.

Preclinical results are lab-based studies that take place before human trials. Human trials come after toxicology and animal trials, and are divided into phase 1 for safety, phase 2 for efficacy, and a broad-based phase 3 study that checks whether it works in a wider range of people.

Putting down bad cholesterol

LDL is the ‘bad’ cholesterol. Nyrada says its inhibitor works by inhibiting the function of the PCSK9 protein which stops LDL receptors from binding to cholesterol and clearing it from the body.

The Nyrada results were confirmed when the statin Mevastatin was added to the process as well, indicating the potential to develop a combined PCSK9-statin single pill treatment for high LDL cholesterol.

Nyrada wants to replace expensive ongoing injections with the first ever oral pill for LDL cholesterol.

Both Repatha and Praluent (the above drugs Nyrada was measuring against) are delivered via subcutaneous injection.

Repatha generated sales of $US661m ($950.7m) in FY2019 for owner Amgen, representing 20 per cent growth year on year. Praluent reached sales of $US288m in FY2019 for its owner, Regeneron/Sanofi.

“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,” Nyrada scientific advisor professor Gillies Lambert said.

Nyrada chief James Bonnar said the company was targeting the 70 per cent of patients at risk of cardiovascular disease who take a statin but are still unable to reach their target LDL cholesterol level, and people who are statin-intolerant.

Nyrada was spun out of cancer hopeful Noxopharm (ASX:NOX) in January.

In other ASX health news:

MyFiziq (ASX: MYQ) says its designs for integration with Canada-based NuraLogix are finished, with the app to include “high impact data” using facial blood flow and total body scan for chronic illness assessment and COVID-19 symptoms-assessment. So far 12 companies have registered interest.

Mayne Pharma Group (ASX: MYX) has entered into a long-term supply agreement with Novast Laboratories for 13 US generic oral contraceptive products, including five new products not previously marketed by the company.

Four of the new products are FDA approved and include generic equivalents of two of the highest prescribed oral contraceptive products in the US. The fifth product is pending at the FDA. According to IQVIA, the annual US market sales for the five additional products were $US500m with more than 1.3 billion tablets sold annually.