Please login to the form below

Not currently logged in

Sanofi/Regeneron’s Dupixent successor underwhelms in phase 2

Success against placebo, but fails to outperform Dupixent


Sanofi and Regeneron’s investigational IL-33 antibody has hit its primary endpoints against placebo in a phase 2 asthma study, but failed to outperfom the partners' existing treatment Dupixent.

This has cast doubt on it prospects, and those of a rival IL-33 pipeline candidate.

REGN3500 is a IL-33 inhibitor which targets one of the key proteins thought to play a role in type 1 and type 2 inflammation.

The companies are looking to build on the success of Dupixent, which is already a $1bn+ blockbuster, and is picking up multiple licences across inflammatory conditions.

Dupixent inhibits the IL-4 and IL-13 proteins, and is already approved in severe asthma in the EU, and gained its atopic dermatitis approval in the US in March.

However the new results for REGN3500 are underwhelming. The phase 2 trial involved 296 adult patients with moderate-to-severe asthma, who were not well controlled by inhaled corticosteroid and long-acting beta-agonist therapy. REGN3500 met its primary endpoint, improvement in loss of asthma control, when compared to the placebo group, and also met the secondary endpoint of showing significant improvement in lung function in comparison to the placebo group.

However one arm of the trial also compared REGN3500 with Dupixent, and these results showed the established drug performed numerically better than the candidate across all endpoints.

The trial also showed that when combined, REGN3500 and Dupixent did not show increased benefit when compared to Dupixent monotherapy in this trial, although the companies point out that the trial was not powered to demonstrate this endpoint.

REGN3500 is also being studied in phase 2 trials for chronic obstructive pulmonary disease and atopic dermatitis.

Sanofi/Regeneron have promised more detailed results are upcoming, but the results are disappointing and leave the partners in a quandry about how to proceed with further trials.

The underwhelming results also hit shares of biotech AnaptysBio’s, which has its own IL-33 antibody therapy in development in atopic dermatitis.

Article by
Lucy Parsons

24th June 2019

From: Research



Featured jobs

Subscribe to our email news alerts


Add my company
Publicis Resolute

Publicis Resolute provides real-life practical solutions to your issues, without fuss or fluff. We are an experienced team with a...

Latest intelligence

Dimitri Azzopardi
Case-study for thalassaemia: Dimitri Azzopardi
An in-depth look at beta thalassaemia for Rare Disease Day...
Delivering change through better rare disease communications
OPEN Health’s Richard Jones, Gemma Allen and Charlotte Richards discuss how pharma can utilise tools, channels and stakeholders to deliver change and enable better outcomes....
Interim analysis clinical trials
Assessing the value of interim analyses in clinical trials
Why its important and when its needed...