Neovacs starts phase IIb trial of IFNa-Kinoid to treat lupus

The company started enrolling patients in IFN-K-002 double-blind, randomized, placebo-controlled, multi-center study to identify the biological and clinical efficacy of IFNa-Kinoid in patients suffering from SLE.

Neovacs intends to enroll 166 patients across 19 countries in Europe, Asia and Latin America. The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first treatment with IFNa-Kinoid.

The clinical trial’s results are anticipated to be revealed in the first quarter of 2017.

Neovacs CEO Miguel Sieler said: "With the initiation of this Phase IIb study, we have reached an important milestone in the development of IFNa-Kinoid.

"The first centers of the trial are now up and running, with more centers planned to open in the coming weeks, which will accelerate the recruitment for the study. IFN-K-002 is a key trial for Neovacs, and for our active immunotherapy approach to the treatment of lupus."

Earlier this month, Neovacs secured first approvals by regulatory agencies and ethics commitees in several European countries for a phase IIb trial in lupus.

The company assessed the trial using the Voluntary Harmonization Procedure (VHP) of Europe’s Heads of Medicine Agencies.

Neovacs said the self antibodies produced by administration of the IFNa-Kinoïd neutralize all 13 sub-types of IFNa in the serum of lupus patients.

A phase I/II clinical trial of IFNa-Kinoïd in lupus patient was undertaken in 2010-2011.