Sanofi SA (NASDAQ:SNY) on Wednesday announced that it will discontinue its Phase 3 MOBILIZE study evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who had not responded to standard treatments.
CIDP is a rare, acquired autoimmune disorder of the peripheral nervous system in which the body’s immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system.
The decision followed an assessment by an independent data monitoring committee, which determined that the study was not expected to meet its efficacy objectives.
Sanofi said the review did not identify any safety concerns related to riliprubart.
Sanofi To Review Broader Riliprubart Development Program
The company said it will assess the future of other ongoing riliprubart studies, including the Phase 3 VITALIZE trial involving CIDP patients receiving intravenous immunoglobulin (IVIg) therapy.
The French drugmaker also plans to conduct a detailed analysis of the MOBILIZE data.
Analysts Point To Trial Design Challenges In CIDP
According to William Blair analyst Myles R. Minter, the MOBILIZE failure highlights the difficulties associated with conducting parallel-group controlled studies in CIDP populations.
The analyst noted that this challenge was one reason Argenx SE (NASDAQ:ARGX) initially evaluated Vyvgart using a randomized-withdrawal design in its ADHERE study.
Minter also pointed to Dianthus Therapeutics Inc. (NASDAQ:DNTH), which is developing claseprubart in the randomized-withdrawal CAPTIVATE study.
He said the trial design may reduce risk by addressing diagnostic and enrollment challenges that have affected CIDP studies.
For Argenx’s empasiprubart, the analyst said the EMVIGORATE and EMNERGIZE studies, expected to report results in the second half of 2027, share similarities with the riliprubart program.
However, he noted that Argenx’s experience conducting successful CIDP studies and confirming diagnoses should not be underestimated.
Minter added that setbacks among competing therapies could further enhance Vyvgart’s commercial standing in CIDP, which he described as one of biotechnology’s strongest product launches.
SNY Stock Price Activity: Sanofi shares were up 1.12% at $44.06 during premarket trading on Thursday, according to Benzinga Pro data.
Image via Shutterstock
Login to comment