Nyrada reports 'encouraging' early efficacy results from PCSK9i program

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Nyrada (ASX:NYR) has reported what it describes as "encouraging efficacy results" from its cholesterol-lowering drug program that is directed at developing an oral PCSK9 inhibitor treatment. 

The company said preliminary data from an in vivo study evaluating its NYX-PCSK9i has shown it reduces total cholesterol, including LDL cholesterol, in the APOE*3-Leiden.CETP mouse model by 57 per cent.

It said two dose levels (30 and 50 mg/kg) were administered and evaluated over 28 days with a dose-dependent response observed. No adverse effects were identified and NYX-PCSK9i was well-tolerated at both dose levels.

Nyrada said additional exploratory analyses will continue for secondary study measures, which Nyrada anticipates reporting in the New Year.

According to Nyrada CEO James Bonnar, “These very encouraging results advance the possibility for an effective, convenient, and cost-competitive oral PCSK9 inhibitor cholesterol-lowering treatment, either as a monotherapy for those who are statin-intolerant or combined with a generic statin in a single pill.

"This would benefit the 70 per cent of patients at risk of cardiovascular disease who struggle to reach their target LDL cholesterol level despite taking a statin. Currently, the best option for these patients is ongoing adjunct treatment on top of a statin with expensive and inconvenient injectable drugs such as Repatha and Praluent, or Leqvio the injectable siRNA inhibitor recently approved in Europe.”

Mr Bonnar added, “The lipid management medicine market is substantial and growing, with statins Crestor and Lipitor the number 1 and 2 most prescribed drugs in Australia. Combined global sales of Repatha or Praluent exceeded US$900 million in FY2019. We look forward to updating the market with further results as we advance the program towards the first human study in late 2021.”

The company said the results from the in vivo study indicate that, under similar testing conditions, NYX-PCSK9i is comparable with FDA approved cholesterol-lowering drugs from the statin and PCSK9 biologic class.