Australian company Nyrada (ASX:NYR) has reported new exploratory results of a study involving its investigative oral cholesterol-lowering PCSK9 inhibitor.
The company said new results from an exploratory arm in its in vivo efficacy study of 'NYX-PCSK9i' build on the 57 per cent reduction in total cholesterol announced in late 2020.
It said additional laboratory test results confirm that NYX-PCSK9i lowered LDL ('bad') cholesterol in a dose-dependent manner.
According to Nyrada, the results compare favourably in terms of total cholesterol reduction with historical in vivo trials of Pfizer's LIPITOR (atorvastatin) and Sanofi's injectable PCSK9 monoclonal antibody, PRALUENT (alirocumab).
Amgen's monthly PCSK9 monoclonal antibody, REPATHA (evolocumab), is reimbursed through the PBS. Novartis is also working to commercialise the six-monthly cholesterol-lowering therapy LEQVIO (inclisiran) it acquired through the US$9.7 billion takeover of The Medicines Co.
Nyrada said the additional results show NYX-PCSK9i does not affect body weight, food intake or the liver function of treated animals while reducing LDL cholesterol levels.
"The data supports the continued development of the Company’s hypercholesterolemia clinical candidate towards the clinic. It also confirms the suitability of NYX-PCSK9i as a potential oral treatment that can be combined with a statin in a single pill for the large cohort of patients that cannot reach their targeted LDL cholesterol levels taking a statin alone," said the company.
“The new results build on the impressive cholesterol-lowering results announced in December. They provide further evidence of a clear dose-response and confirm that NYX-PCSK9i dramatically reduces LDL or 'bad' cholesterol. The next step, in addition to conducting further safety testing, is to determine what level of enhancement can be achieved by combining NYX-PCSK9i with statin, in the same mouse model,” said Nyrada CEO James Bonnar.
“The Nyrada team is excited to be working on the development of a small molecule PCSK9 inhibitor drug as the optimal treatment approach for reducing cholesterol. Such a drug will provide an effective, convenient, and cost-competitive treatment that would benefit the 70% of patients at risk of cardiovascular disease who are unable to reach their target LDL cholesterol level despite taking a statin1,” added Mr Bonnar.