vatelizumab (GBR 500) / Glenmark - LARVOL DELTA

Optimizing Treatment Strategies to Manage Inflammatory Bowel Disease - Episode 15: Emerging Treatments Over the Horizon for IBD (HCPLive) - "Jessica Allegretti, MD, MPH: I'm most excited for, at the current moment, the selective JAKs to be coming down the line, especially for Crohn disease. That's really what I have my eye on, in addition to, as Bill just mentioned, the IL-23 inhibitors....Edward Loftus Jr., MD: Some of the etrolizumab UC [ulcerative colitis] results were clearly mixed and somewhat disappointing, but don't forget, we still have a Crohn [disease] trial out there....William Sandborn, MD: We're at the end of the beginning of the revolution of IBD therapy. Buckle up-a lot of new stuff will come, but we have an amazing repertoire of therapies that we can use today."

Video

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2; N=168; Not yet recruiting; Sponsor: Genzyme, a Sanofi Company

New P2 trial • Phase shift • Biosimilar • Immunology • Multiple Sclerosis

EMPIRE: Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2; N=168; Recruiting; Sponsor: Genzyme, a Sanofi Company; Trial primary completion date: May 2016 ➔ Nov 2015

Trial primary completion date • Biosimilar • Multiple Sclerosis

Sanofi: Q3 2015 Results (Sanofi) - “Sanofi has decided not to pursue development of vatelizumab, following the results of a Phase II pre-planned interim analysis in Multiple Sclerosis that revealed the primary efficacy endpoint was not met”

Discontinued • Multiple Sclerosis

Efficacy and safety of SAR339658 in patients with moderate to severe ulcerative colitis (FUSCIA) (clinicaltrials.gov) - P2, N=84; Not yet recruiting -> Recruiting

Enrollment open • Inflammatory Bowel Disease

Q1 2014 business EPS up 5.8% at CER (Sanofi Press Release) - "Sanofi has decided not to pursue the development of SAR 339658, an anti-VLA 2 monoclonal antibody, in ulcerative colitis and will instead focus on evaluating the use of this compound in multiple sclerosis by initiating a clinical Phase II study."

Anticipated new P2 trial • Discontinued • Inflammatory Bowel Disease • Multiple Sclerosis

Glenmark goes west for $250 billion drug market: Corporate India (Bloomberg Business Week) - "A biologic remedy for ulcerative colitis...is progressing through U.S. trials after being licensed to Paris-based Sanofi and may come to market from 2017 to 2020..."

Anticipated launch • Inflammatory Bowel Disease

VLA-2 blockade in vivo by vatelizumab induces CD4+FoxP3+ regulatory T cells. (PubMed, Int Immunol) - "Elevated TREG frequencies might be explained by the inhibition of p38 mitogen-activated protein kinase (MAPK) signaling, which is critically involved in the polarization of T helper 17 cells and is activated by the α2 integrin cytoplasmic domain. Our findings suggest that blockade of VLA-2 might be a way to safely shift the T helper 17 / TREG balance by inducing TREGin vivo."

Journal • Preclinical