The Phase 2b clinical trial evaluating interferon-alpha (IFNα) Kinoid, Neovacs’ immunotherapy candidate for the treatment of systemic lupus erythematosus (SLE), received a positive interim data review from the Independent Data and Safety Monitoring Board (IDSMB) overseeing the study.
The randomized, multicenter and international clinical trial (NCT02665364) is evaluating the biological and clinical effectiveness of IFNα Kinoid, versus placebo, in the treatment of moderate-to-severe SLE.
The trial, which opened in September 2015, is well on its way to enrolling 178 patients in 21 countries in Latin America, Asia, Europe and the U.S.
“We are satisfied that the IDSMB, following the second data review meeting, has issued a favorable opinion regarding the continuation of our Phase IIb clinical study in Lupus, which is a rare disease with a high unmet medical need. Importantly, we have already recruited more than two thirds of the patients out of the planned 178 into the study,” Thérèse Croughs, Neovacs’ chief medical officer, said in a press release.
Primary outcome measures include the change from baseline, or study start, in the expression of IFN-induced genes at week 36, and the response to IFNα Kinoid treatment as measured by the BILAG-based Composite Lupus Assessment (BICLA) response criteria at week 36.
Secondary outcomes will measure, also at week 36, response to treatment using the SLE Responder Index (SRI)-4 criteria, and the number of participants with treatment-related adverse events.
SLE, like other autoimmune and inflammatory diseases, is characterized by excessive production of cytokines, small proteins released by cells that have specific effects on cell interactions and intra-cellular communication, that can promote inflammation and immune system dysregulation. IFNα Kinoid is a therapeutic vaccine designed to induce an immune response and stimulate the production of polyclonal antibodies against interferon-alpha (and its subtypes), a cytokine involved in innate immune response.
IDSMBs oversee and review the data collected during a clinical trial to ensure that studies are properly conducted. The committee is composed of multidisciplinary experts, and its member can interrupt or modify a clinical trial based on data reviews.