Sanofi has reported positive mid-stage clinical trial results for an oral therapy for multiple sclerosis, that is seen as a key pipeline project for the drugmaker as it resets an underperforming business.
SAR442168 – a BTK inhibitor licensed from Principia Biopharma that can cross the blood brain barrier – significantly reduced disease activity associated with MS measured using magnetic resonance imaging (MRI) in the phase 2b study.
Sanofi thinks it could be the first disease-modifying therapy for MS that tackles inflammatory damage to neurons in the brain, differentiating it from other medicines that work mainly on peripheral neurons.
“The vast majority of people living with MS still endure disability during the course of their disease,” commented Sanofi’s head of R&D John Reed. “We believe our BTK inhibitor has the potential to transform how MS is treated,” he added.
Sanofi is now moving ahead with a four-trial phase 3 programme for SAR442168, which will start later this year in both relapsing and progressive forms of MS. It will assess the drug’s impact on relapse rates, disability progression and underlying central nervous system damage.
Should its encouraging profile be backed up by those trials, that could set up blockbuster sales revenues for SAR442168, and help recently-appointed chief executive Paul Hudson’s efforts to turnaround the fortunes of the company.
Under Hudson, Sanofi is trying to slim down the organisation and restructure its approach to R&D, for example by abandoning research into new diabetes and cardiovascular disease products, while increasing its investment in immunological/inflammatory diseases, rare blood disorders, cancer and vaccines.
The company is also following a trend among other big pharma groups like GlaxoSmithKline, Pfizer and Merck & Co by hiving off some parts of its business to reinvest in its pipeline. To that end, it is considering a spin-off of its consumer health operations.
The new MS data comes as Sanofi swung to a small, €10m net loss in the fourth quarter of 2019, despite another strong performance by immunology drug Dupixent (dupilumab) which grew 135% to €679m ($747m) in the period.
Dupixent plus solid growth for Sanofi’s vaccines business lifted revenues for the quarter 6.8% to €9.6bn, and the company is now predicting that Dupixent could eventually become a €10bn product. For 2019 as a whole it topped €2.1bn in sales.
Sanofi already has an established MS franchise with oral therapy Aubagio (teriflunomide) and Lemtrada (alemtuzumab), but that declined 3% to €540m in the fourth quarter on competition in the increasingly-crowded MS market.
“We are making great progress in our ambition to transform Sanofi R&D and I am particularly excited by the positive proof of concept data for our BTK inhibitor, a potentially practice changing therapy for multiple sclerosis, announced today,” said Hudson.
“There is increasing momentum across the entire Sanofi organisation and I am confident we will achieve the long-term growth aspirations and margin target,” he added.