Sanofi/Regeneron cholesterol drug reaches Phase III
pharmafile | May 29, 2012 | News story | Research and Development, Sales and Marketing | Amgen, PCKS9, Regeneron, SAR236553, Sanofi
Sanofi and Regeneron’s anti-cholesterol drug has impressed in a mid-stage trial, and will now progress into Phase III.
The firms’ drug, SAR236553, is an injectable fully-human antibody targeting the PCSK9 protein.
In the ‘1003 study,’ published in The Lancet this week, the drug reduced LDL cholesterol by 68%, compared to just 10% in the placebo arm.
The trial randomised 77 patients with heterozygous familial hypercholesterolemia whose LDL-cholesterol levels remained uncontrolled on statin therapy with or without MSD’s Zetia (ezetimibe).
Based on these results and discussions with regulators, Sanofi and Regeneron said they now intend to begin a global Phase III trial of SAR236553 in June.
This will be the first Phase III study of an investigational drug targeting PCSK9, putting it ahead of its competitors.
Dr Elias Zerhouni, president of global R&D at Sanofi, said: “Our global Phase III program will include patients with high unmet medical need, such as patients with familial hypercholesterolemia or with elevated cardiovascular risk who cannot reach their LDL-cholesterol goals with current standard therapies.
“The programme reflects our excitement and commitment to develop this potential therapeutic option for these patients.”
George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron laboratories, said: “These data, along with recently presented data in patients with hypercholesterolemia, further support our belief that blocking PCSK9 with our antibody has the potential to offer a novel mechanism for lowering LDL-cholesterol in a broad range of patients.”
The two firms are in competition with Amgen’s AMG 145, also an injectable antibody targeting the PCSK9 protein, which is currently undergoing Phase Ib trials.
Whilst behind in the development race, Amgen may have an edge with AMG 145 as it can be injected just once a month, whilst Sanofi’s SAR236553 is administered every fortnight.
The blocking of the PCSK9 pathway is a potentially novel mechanism for lowering LDL-cholesterol, and all the firms involved will be banking on its future success.
Analysts expect the new class of drugs, including those in earlier stages of development at Merck and Bristol-Myers Squibb, to generate annual future sales of up to $20 billion.
Ben Adams
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