Swiss pharma company Novartis has readjusted the timings for a major study of its cholesterol drug Leqvio in the UK, after facing issues with recruitment due to the COVID-19 pandemic.
In January 2020, Novartis announced that it had teamed up with the UK’s National Health Service (NHS) on a clinical trial – ORION-4 – of the drug.
The trial is utilising NHS data to identify patients across the country who are at risk of heart disease who have not improved with conventional treatment regimens, including statins.
Leqvio (inclisiran) is a small interfering RNA (sIRNA) with a new mechanism of action that allows it to deliver effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction for patients with a number of cardiovascular risk factors.
It works by blocking the synthesis of PCSK9 in the liver rather than targeting the protein itself, which allows more receptors on the liver cell surface to capture LDL cholesterol to break down.
In an earnings call held earlier this week, Novartis’ head of global drug development and chief medical officer responded to questions regarding the expected delayed results from the UK study of Leqvio.
“As we’ve seen both with COVID-19 and then the additional variants with the impact of COVID-19 in the UK, recruitment has been challenging. Initially in December as we saw, there was an uptick in COVID-19 cases in the UK,” commented Tsai.
“And then subsequently, throughout the first quarter of the year in the UK, there was a significant impact of COVID-19. So, based on the recruitment timelines, we have deferred the study results to 2026,” he added.
Tsai addressed the ORION-4 delays amid a discussion of Novartis’ first quarter results for 2021. In its Q1 results, Novartis reported a 5% decline in net income during this period, or 7% at constant exchange rates (CER) from the previous year.
Earnings per share were also down to $0.91 to $0.96 compared to the same period in 2020, with quarterly operating income also decreasing 14% at CER.
Novartis maintained growth of net sales in the low- to mid-single digits for 2021, although the company said that sales in its Sandoz unit are expected to decline in the low- to mid-single digits.