Fernando Dangond, MD, MBA

“We are very excited because we know the drug works on B cells, which have been shown to have a central role in progression in MS, and on macrophages

. This creates an avenue for us because we have a small-molecule drug that is an irreversible and highly selective inhibitor of BTK [which] plays a very essential role in the inflammatory potential of both.”

2020 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC 2020)

 suggest that the efficacy and safety of 75-mg evobrutinib, an investigational, oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor, is maintained over the long-term in the treatment of patients with relapsing multiple sclerosis (MS).

Those who received EMD Serono’s agent had an annualized relapse rate (ARR) of 0.11 (95% CI, 0.04—0.25) at Week 48, and 0.12 (95% CI, 0.06–0.22) for the full 108-week period. Evobrutinib was also considered generally well-tolerated, maintaining its known safety profile during the open-label extension period, with transient elevated liver aminotransferases, which was reported in the 48-week double-blind period, not observed in the extension.

The phase 2 randomized controlled trial (NCT02975349) included 213 patients (79.8% of the 267 randomized) who were treated for 108 weeks, which consisted of the 48-week main study and 60-week open-label extension. To find out more, 

 connected virtually with Fernando Dangond, MD, MBA, head, Global Clinical Development in Neurology, EMD Serono.

1. Montalban C, Arnold DL, Weber MS, et al. Efficacy and Safety of the Bruton’s Tyrosine Kinase Inhibitor (BTKI) Evobrutinib in Relapsing Multiple Sclerosis over 108 Weeks: Open-Label Extension to a Phase 2 Study. 

. 2020;22(2 Suppl). Late-Breaking Abstract.

2. New Late-Breaking Data at EAN Indicate Evobrutinib is the First BTK Inhibitor to Report Efficacy and Safety in MS Over 108 Weeks [press release]. Rockland, MA: EMD Serono; Published May 23, 2020. Accessed May 26, 2020. biospace.com/article/releases/new-late-breaking-data-at-ean-indicate-evobrutinib-is-the-first-btk-inhibitor-to-report-efficacy-and-safety-in-ms-over-108-weeks

Videos

Head of Global Clinical Development in Neurology at EMD Serono discussed the findings of a phase 2 assessment of the company’s investigational BTK inhibitor evobrutinib in multiple sclerosis.

Fernando Dangond, MD, MBA: Phase 2 Data on Evobrutinib in MS

“I think [people] are going to be excited because this is an oral treatment, and the first-in-class to show that it works in MS.”

In a phase IIb trial, evobrutinib met the study’s primary end point, significantly reducing the number of T1-gadolinium enhancing (T1-Gd+) lesions in comparison with placebo.

A first-in-class medicine, the highly-specific, oral Bruton’s Tyrosine Kinase (BTK) inhibitor is the first BTK inhibitor to show clinical proof-of-concept in relapsing multiple sclerosis (MS). Thus far, the treatment has also proven well tolerated.

To gather more insight into evobrutinib’s performance in the trial, 

 sat with Fernando Dangond, MD, MBA, the Head of Global Clinical Development in Neurology at EMD Serono, the therapy’s manufacturer. Dangond, also a study author, noted that the treatment’s dual mechanism of action—targeting both microphages and B cells&mdash;is one of its more unique features.

Additionally, at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany, Dangond shared that he was surprised by the drastic reduction that was observed. Planning for a phase III trial is underway.

The Head of Global Clinical Development in Neurology at EMD Serono provided insight into the therapy's performance in phase IIb.

Fernando Dangond, MD, MBA

Articles

Fernando Dangond, MD, MBA: Phase 2 Data on Evobrutinib in MS

Fernando Dangond, MD, MBA: Evobrutinib for Relapsing Multiple Sclerosis