Friday, June 23, 2017

Dekavil at the 2017 EULAR Annual Meeting in Madrid

Dekavil (F8-IL10) is a fully human immunocytokine, composed of the antibody fragment F8 fused to the anti-inflammatory cytokine interleukin-10 (IL-10). I’ve come across dekavil for the first during the 2012 EULAR Annual Meeting in Berlin [1]. I’ve been quite mad after the 2013 EULAR Annual Meeting in Madrid [2]: “Please promise to publish more than promising data at the ACR 2013 at the next ACR meeting.”

M. Galeazzi and colleagues published a phase 2 study [3] titled: “SAFETY, TOLERABILITY AND INITIAL SIGNS OF EFFICACY OF THE FULLY HUMAN IMMUNOCYTOKINE DEKAVIL (F8IL10): A NOVEL THERAPEUTIC APPROACH FOR RHEUMATOID ARTHRITIS”. The abstract is difficult to read as it also looks at data from a phase 1b study. “As of January 2017, 22 out of 87 patients have been treated in the phase 2 clinical study and neither SUSAR [Suspected Unexpected Serious Adverse Reaction] nor treatment-related deaths were recorded.” Conclusions: “The currently available data suggest that Dekavil is a safe and promising novel therapeutic for the treatments of RA.” I don’t see such a conclusion. And yeah, there we are again – promising.

Adisinsight reports termination of a phase 1 trial in Inflammation (in volunteers) in the US in2016 and of a phase 2 clinical trials in rheumatoid arthritis in Italy in 2014 [4].
On the other hand this study “A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX” is marked as “is currently recruiting participants” in Clinical Trials [5].

It’s hard to share the enthusiasm of the authors. The idea of getting IL-10 to where inflammation is raging is wonderful. I don’t want to sound like a merchant of doom, but I have my doubts about dekavil.

Links and References:
[3] DOI: 10.1136/annrheumdis-2015-eular.3889


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