Tuesday, December 18, 2012

ALX-0061 at the ACR Annual Meeting 2012 in Washington

New data from the EULAR 2013 here: http://rheumatologe.blogspot.de/2013/06/alx-0061-anti-il-6-receptor-nanobody-at.html

“ALX-0061 is a bispecific anti-IL-6R Nanobody”. There have been two studies at the ACR Annual Meeting 2012 in Washington. Abstract 336 discussed the preclinical development of ALX-0061 (Dear Ablynx, please see that your drug gets a name, quickly!). In this abstract high in vitro affinity and potency with favorable PK/PD properties in non-human primates of ALX-0061 has been discussed. To my great annoyance the conclusion ran further: “A Phase I/II clinical trial is ongoing. Interim analysis of the single ascending dose part were encouraging, results from the multiple dose part are expected in H2 2012.” That isn’t a conclusion that’s marketing!

St. De Bruyn and colleagues presented: "Anti-IL-6 Receptor Nanobody (ALX-0061) Seamless "First-in-Human" Phase I/II POC Study in Patients with Active RA On Stable MTX Treatment" (Abstract No. 1307). Conclusions included: "The MAD study part [multiple ascending dose] will further assess early effect of ALX-0061 on disease activity with radiographic and clinical disease score evaluations."

Let’s wait and see if ALX-0061 is going to be marketed. And before the question should be addressed if ALX-0061 is better than tocilizumab.

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