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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Replimune CRL Could Hold Warning For Accelerated Approvals

 

FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.

Sanofi Doubles Down On Respiratory Vaccines With Vicebio Buy

 
• By 

The French major is paying $1.15bn For the UK biotech and its bivalent candidate, VXB-241.

Chinese Biotechs Sweep ADC Plus PD-(L)1/VEGF Bispecific Combos Into Phase II

 

Chinese firms Junshi, Minghui and RemeGen rank among the world’s few players progressing antibody-drug conjugates combined with PD-(L)1/VEGF bispecific antibodies in Phase II trials for various cancers.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

More from R&D

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

Pipeline Watch: Five Approvals And Twelve 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.

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By 

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.