Understanding How To Develop BTK Inhibitors In MS Is Evolving

Having a reversible BTK inhibitor in the multiple sclerosis armamentarium could be the best way to favorably impact the treatment landscape.

Microglia cells
Microglia immune cells in the brain • Source: Shutterstock (Shutterstock)

The failure of Merck KGaAs Phase III trials of the BTK inhibitor evobrutinib in multiple sclerosis (MS) raises several questions about the use of this class of compounds to treat the disease. Safety has long been a concern for these molecules: at various times, MS trials of evobrutinib, Sanofi’s tolebrutinib and, most recently, Roche Holding AG’s fenebrutinib have, to some degree, been placed on clinical hold by FDA. Also see "Clinical Hold For Merck KGaA’s BTK Inhibitor Evobrutinib For MS Raises Class Safety Fears" - Scrip, 12 April, 2023. Also see "Sanofi’s MS Candidate Tolebrutinib On Clinical Hold Following Liver Toxicities" - Scrip, 30 June, 2022. New drugs have emerged as compelling treatments for relapsing MS, making the design of late-stage clinical trials increasingly challenging. Similarly, the sweet spot for proving the value of new MS drugs is shifting towards progressive forms of the disease and a focus on treating disability with high-potency drugs, not preventing relapses.

Merck announced the results of its two pivotal EVOLUTION studies of evobrutinib on 6 December, 2023. Neither met the primary...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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 Innovation

CRL Trio Brings Shifting Sand To Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

When Simple Is Best: A Pre-Term Birth Device To End The ‘Silent Emergency’

 
• By 

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

Podcast: Scancell’s Cancer Vaccine Progress With NHS Partnership

 
• By 

In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.

Trojan Bio Eyes Perfect Rainbow Shot With Immune System Cancer Innovations

 
• By 

Trojan Bio’s proprietary platform, based on engineered antibodies that activate the immune system to fight cancer in the same way as common viral infections, won Biomed Israel's 2025 biopharma start-up award. CEO and cofounder Anat Burkovitz said the technology is attracting investors' attention.

More from In Vivo

Rising leaders 2025: Aneesh Karatt-Vellatt On Maxion Therapeutics’ Antibody Revolution

 
• By 

Aneesh Karatt-Vellatt is leading the charge to redefine how ion channels and G protein-coupled receptors (GPCRs) are targeted with antibody therapies, one of the most notoriously challenging classes of drug targets.

Podcast: Scancell’s Cancer Vaccine Progress With NHS Partnership

 
• By 

In the latest podcast interview, Phil L'Huillier, CEO of Scancell, discussed the company's work in cancer vaccine development, and its selection as the first British biotech to be a part of the NHS Cancer Vaccine Launch Pad.

Geopolitical Volatility Not Dimming A Healthy Mid-Term Outlook For Life Sciences Deals

 
• By 

New report by global law firm Taylor Wessing and Bayes Business School forecasts a steadily increasing volume of major life sciences M&A in the coming five years, but highlights concerns over cybersecurity and unrealistic valuations. Taylor Wessing partner Andrew Edge spoke to In Vivo.