Sanofi plans 2021 restart for pediatric hemophilia trial hit by fallout from thrombotic events

Sanofi plans to resume dosing and recruitment in its pediatric fitusiran clinical trial later this year. The study has been halted since the identification of vascular thrombotic events in the broader haemophilia program at the end of last year.

After dose interruption in all fitusiran studies in late October, Sanofi resumed administration of the RNAi drug to adolescents and adults in the US in December. As Sanofi explained at the annual conference of the European Association for Hemophilia and Related Conditions in February, the reboot was made possible by a change in the dosing regimen and targeting higher anti-thrombin levels.

At the time, Sanofi said the risk mitigation plan for the pediatric study was still under development. France’s Big Pharma provided additional details in its first-quarter results on Wednesday, outlining plans to resume dosing and recruitment of pediatric haemophilia A and B patients later this year.

Sanofi announced its pediatric plans as part of a broader update on its pipeline, including details of its decision not to subscribe to Regeneron’s REGN4018, REGN5459 or REGN5458.

REGN4018 is a phase 1/2 clinical development bispecific antibody against Mucin 16 for the treatment of ovarian cancer. REGN5459 and REGN5458 are both anti-BCMA bispecific agents that Regeneron is studying in early human multiple myeloma clinical trials.

Recent changes leave Sanofi free to develop rival drugs. “Sanofi no longer has non-compete clauses with rejected candidates under the amended and revised IO Discovery and Development Agreement, which ended March 16, 2021,” French Big Pharma wrote in its update.

Separately, Sanofi terminated the development of ROR gamma T antagonist SAR441169 in psoriasis. Sanofi developed the drug through its collaboration with Lead Pharma and brought it into phase 1 in 2019. Finally, Sanofi stopped developing T cells that target the multispecific antibody SAR440234 in leukemia. Sanofi took the anti-CD123 candidate to the clinic in 2018.

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