Roche/Chugai’s Enspryng Not Good Enough In Phase III Myasthenia Gravis Study

Three Phase III Trials Ongoing In Three Other Indications

Many companies have late-stage myasthenia gravis programs in Phase III, but argenx and its Vyvgart competitors won a reprieve with the failure of IL-6 inhibitor Enspryng (satralizumab).

Concept of Myasthenia Gravis written on sticky notes isolated on Wooden Table.
The myasthenia gravis pharma market is growing despite some setbacks • Source: Shutterstock

Roche Holding AG subsidiary Chugai Pharmaceutical Co., Ltd.’s IL-6 receptor inhibitor Enspryng (satralizumab) achieved statistical significance on the primary endpoint in the Phase III LUMINESCE clinical trial in generalized myasthenia gravis (gMG), the firm announced 21 March, but the results did not meet the companies’ expectations on the degree of benefit versus placebo. The failure gives gMG market leader Vyvgart (efgartigimod alfa) from argenx N.V. more breathing room ahead of other competitors’ expected Phase III readouts in the disease.

Key Takeaways
  • Roche subsidiary Chugai said Enspryng did not meet the companies’ expectations for the drug in generalized myasthenia gravis (gMG) despite achieving statistical significance in a Phase III study.

Argenx, whose drug achieved blockbuster status in 2023 with $1.2bn in sales, gained 11.2% on the Enspryng news to close...

Welcome to Scrip

Create an account to read this article

More from Clinical Trials

Lilly’s Orforglipron Makes Strong Showing In Diabetic Obesity Population

 

The drugmaker announced topline results from the Phase III ATTAIN-2 trial in overweight/obese patients with type 2 diabetes and plans to file for approval.

Regeneron Plans To File Cemdisiran For gMG But Will Face Tough Market

 

Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.

Pipeline Watch: Twelve Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Argenx’s Vyvgart Positioned For Broadest Label In Myasthenia Gravis

 

The company reported positive Phase III data in individuals with gMG who are ACHr-Ab seronegative, providing an expansion opportunity.

More from R&D

Pipeline Watch: Twelve Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Argenx’s Vyvgart Positioned For Broadest Label In Myasthenia Gravis

 

The company reported positive Phase III data in individuals with gMG who are ACHr-Ab seronegative, providing an expansion opportunity.

Pipeline-In-A-Product: A Retrospective On The Development Of Dupixent

 

Dupixent’s success across eight indications is a model other drugmakers would like to replicate. R&D leaders at Sanofi and Regeneron reflect back on the development strategy that built the $15bn product.