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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