Neovacs begins interferon-alpha-kinoid phase 2b study in patients with SLE

Neovacs announced it has begun enrollment of patients with systemic lupus erythematosus in a phase 2 clinical trial of its interferon--kinoid agent, IFN-K-002, according to a company press release.

The company presented details of a previous human study of the interferon--kinoid agent in six patients with systemic lupus erythematosus (SLE) at the 11th International Congress of Systemic Lupus Erythematosus earlier this month in Vienna. The company plans to enroll 166 patients from Europe, Asia and Latin America for the upcoming study.

“With the initiation of this Phase 2b study, we have reached an important milestone in the development of interferon--kinoid,” Miguel Sieler, CEO of Neovacs, said in the release. “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.”

In previous studies, interferon--kinoid was associated with neutralization of interferon- antibodies and a decrease in the expression of induced genes associated with B-cell activation. Two of the five patients in the phase 1/2a study who had a positive interferon signature developed neutralizing antibodies and had increases in C3.

“The results we presented at Lupus 2015 show that our lead product candidate induces a lasting, polyclonal, neutralizing anti-IFN response in SLE patients,” Chief Medical Officer of Neovacs, Thérèse Croughs, MD, said in an earlier press release.

The results of the upcoming study will be based on the British Isles Lupus Assessment Group (BILAG) composite scores and biological efficacy at 9 months after the first treatment with IFN-K-002.

Reference : http://neovacs.fr.