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Sanofi’s sutimlimab set for filing in rare autoimmune anaemia next year

Late-stage candidate hit the mark in phase 3 study

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Sanofi is heading for a major revamp of its R&D operations under the new chief executive Paul Hudson, but in the meantime one of its late-stage projects seems to have delivered on its promise.

Sutimlimab – a first-in-class selective inhibitor of complement C1s – has hit the mark in cold agglutinin disease (CAD), a rare, autoimmune form of haemolytic anaemia that causes blood clots, leading to patients requiring repeated blood transfusions and can shorten their lifespan.

There are no approved therapies for CAD, but Sanofi R&D chief John Reed says the company could now be in a position to file for US approval in early 2020 with an FDA verdict possible as early as the third quarter thanks in part to the drug’s breakthrough status.

If that’s the case, its another win for Sanofi’s immunology programme, which has already delivered fast-growing atopic dermatitis and asthma therapy Dupixent (dupilumab), and reinforces Hudson’s decision to invest more in this area while reining in traditional areas like diabetes and cardiovascular disease.

In the phase 3 CARDINAL study reported at the ASH congress this week, sutimlimab given as an intravenous infusion on day zero and day seven – followed by biweekly dosing – achieved the primary objective of increasing haemoglobin levels in CAD patients with a recent history of transfusions.

The primary endpoint in the open-label trial was an increase in haemoglobin of at least 2 g/dL – or an average haemoglobin level of at least 12 g/dL in combination with transfusion avoidance – from weeks five to 26.

Out of 24 adults with the disease in the study, 13 (54%) met the primary endpoint threshold, 15 (63%) achieved a haemoglobin level of at least 12 g/dL or an increase of at least 2 g/dL, and 17 (71%) remained transfusion-free after week five.

Reed said the study revealed “marked improvements in patients’ haemolysis, anaemia and fatigue” with sutimlimab that suggests it could become the first targeted therapy for CAD and “has the potential to change the treatment paradigm” for the disease.

Sanofi acquired rights to sutimlimab as part of its $11.6bn takeover of Bioverativ last year under former CEO Olivier Brandicourt, and has been billed as one of the most promising assets in that deal.

The antibody is also being tested in the phase 3 CADENZA trial involving patients with milder CAD who have not recently had a transfusion, as well as a mid-stage trial in immune thrombocytopenic purpura (ITP).

Article by
Phil Taylor

11th December 2019

From: Regulatory

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