Pfizer has reported positive phase III trial results with its cholesterol-lowering candidate bococizumab, setting up a possible regulatory filing in the coming months.
The company now has two positive phase III trials in hand for the PCSK9 inhibitor, which – if it reaches the market – will compete with Sanofi/Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab).
The latest study – called SPIRE-AI – was a 12-week trial that compared bococizumab delivered using an auto-injector pen to placebo in almost 300 patients with elevated cholesterol levels despite ongoing treatment with statin drugs.
While full results are not yet available, bococizumab met its primary objectives in the study, namely that it achieved a significant reduction in low-density lipoprotein cholesterol (LDL-c) compared to placebo and could be administered effectively by patients themselves using the pen injector device.
An earlier trial called SPIRE-SI met its objective of showing that bococizumab was able to lower LDL-c in adults with elevated cholesterol who cannot tolerate statin drugs.
Pfizer’s head of clinical for cardiovascular and metabolism James Rusnak said: “We believe the SPIRE programme and bococizumab have the potential to play an important role in understanding and helping to address the unmet needs of patients at high risk for cardiovascular disease.
“We continue to maintain focus on delivering our phase III programme, including the two outcomes studies.”
The SPIRE-1 outcomes trial is expected to run until 2018, but additional trials in the phase III programme are due to generate results later this year.
The FDA approved Sanofi and Regeneron’s Praluent last July, just ahead of Amgen’s Repatha, and the drugs have been launched in the US with an annual cost of around $14,000. Both these drugs are available in both pre-filled pen and syringe formulations.
The high annual price of the drugs compared to generic statins has created some resistance among healthcare payers in the US, and neither Sanofi nor Amgen detailed initial revenues from their products in their recent annual results statements.
Last year, the Institute for Clinical and Economic Review (ICER) in the US concluded that the two drugs would need 85% price cuts to make their use cost-effective.
Meanwhile, Amgen and Sanofi are currently locked in a patent battle over their PCSK9 inhibitors, with Amgen claiming victory in the first round of the dispute last month.