29 October 2018

UEGW Highlights

Immunology is one of Vox.Bio’s therapeutic areas of expertise and there is a lot happening in IBD right now. Some of our team went to United European Gastroenterology Week (UEGW) in Vienna to keep up to date with the latest advancements.

At Vox.Bio we believe it is important to stay up to date and truly understand the dynamics of each therapeutic area we work in. Attending congress is a great way to do this, but our team also stays abreast of industry dynamics with continuous secondary desk research. This enables us to effectively engage in our client’s business question and design research to provide high confidence, commercially relevant insights to support brand decision making.

Until relatively recently there were very few therapy options for moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). Therapy was centered around three anti-TNFs; current standard of care Janssen’s Remicade (infliximab), AbbVie’s Humira (adalimumab) and Janssen’s Simponi (golimumab). Since 2014, three other therapies have become available; Takeda’s GI-specific α4β7 Entyvio (launched 2014 UC and CD), Janssen IL-12/IL-23 Stelara (2016 only for CD) and Pfizer’s oral pan-JAK Xeljanz (launched 2018 for UC). But the landscape is likely to change even more over the next five years with approximately 13 assets in the late stage pipeline. 

With so much happening in the IBD pipeline right now, here are the five hot topics that prescribers and KOLs were talking about at UEGW 2018:

  1. Key opinion leaders (KOLs) are hungry for head to head (H2H) data to effectively compare the MoAs. Unlike in RA, where most of the JAK class have conducted H2H trials with SoC adalimumab, in IBD these trials are still somewhat rare. It is a big risk for companies to initiate H2H trials, especially vs SoC infliximab which has demonstrated much higher efficacy than any other asset. Takeda is due to readout Entyvio H2H vs adalimumab at ECCO, we are excited to see the results of this trial, and how Takeda will utilize this data.
  2. Companies are struggling to recruit clinical trials especially, Ph2 and Ph3 due to the crowded pipeline of new assets and large number of Ph4 trials. Last year Roche’s Ph3 etrolizumab programme was delayed due to slower than anticipated recruitment. Celgene is the latest company to suffer from the crowded clinical landscape delaying the Ozanimod UC Ph3 trial by almost two years.
  3. Janssen presented encouraging Stelara induction data from Ph3 UC trial. Momentum around Stelara in CD has been building especially given the convenient Q8W dosing regimen and fast onset of action. This induction data in UC has shown a similar efficacy and safety profile to what prescribers are familiar with in CD. If approved Stelara could be available to patients as early as Q4 2019.
  4. AbbVie presented data from JAK1 upadacitinib Ph2b trial, including data on patient reported outcomes. From as early as eight weeks patients on the U-Achieve trial reported meaningful improvements in QoL, fatigue, work performance and ability to perform daily tasks. It is however unlikely that patients will have commercial access to this drug earlier than 2022. In the meantime, as the only JAK and oral therapy available Pfizer’s Xeljanz (tofacitinib) has a significant opportunity to build market presence.
  5. Takeda presented UC data on the subcutaneous version of their blockbuster Entyvio which is currently only available in an IV-formulation. Approval of this more convenient new formulation will give patients a greater choice and is likely to help Takeda continue to build market share in UC.

As we continue to monitor and work in IBD we look forward to seeing how the therapy algorithm will change over the coming years. If you want to discuss research for your IBD asset please get in touch via contact@vox.bio