First US Patient Enrolls in Phase 2b Study of Therapeutic Vaccine for Lupus

Neovacs announced that it has enrolled the first patient in the United States in its expanded, Phase 2b global clinical trial evaluating IFNalpha-Kinoid,  a therapeutic vaccine, to treat systemic lupus erythematosus (SLE).

The trial (NCT02665364), which began in September 2015, has attracted the interest of American clinical centers and autoimmune disease specialists, and Neovacs planned to extent the trial to five U.S. sites — the first of which enrolled the patient. But given the high demand, the company said it now will open a total of 15 study centers in the U.S.

Neovacs is focused on developing an active immunotherapy technology platform (Kinoids) with applications in autoimmune or inflammatory diseases, from SLE to type 1 diabetes and psoriasis.

Interferon alpha (IFNα) is involved in lupus pathogenesis, and IFNα levels are associated with disease severity. The IFNα-Kinoïd is an anti-IFNα therapeutic vaccine that induces a polyclonal antibody response to potentially treat strategy for patients with lupus. The self-antibodies produced through administration of IFNα-Kinoid have been seen to neutralize several sub-types of IFNα in the serum of lupus patients.

The ongoing-blind, randomized study is testing the vaccine against placebo in up to 178 SLE patients across 21 countries in Europe, Asia, and Latin America. Its co-primary endpoints are biological efficacy and clinical efficacy nine months after first treatment.

Results are expected early next year. Enrollment information for interested lupus patients in the U.S. may be found on the study’s clinical trials.gov website.

“The enthusiasm among U.S. investigators confirms the strong therapeutic interest in our product for the treatment of autoimmune diseases.” Miguel Sieler, CEO of Neovacs, said in a press release. “Our lead drug candidate represents a potentially very interesting option for the treatment of lupus, an area where current therapeutic standards have failed to prove long-term efficacy. This is an area with a significant unmet medical need, and we look forward to continuing the study with the goal or providing a new therapeutic option for patients in need.”

IFNα-Kinoid was named an Investigational New Drug by the U.S. Food and Drug Administration (FDA) in April, the company announced, allowing it to extend the trial to the U.S.

Neovacs concluded a Phase 1/2 clinical trial (NCT01058343) evaluating the safety of IFNα-Kinoid in lupus patients in 2014. A study based on that trial’s results, published in 2013, concluded that the vaccine was a “potentially effective approach in the treatment of lupus,” the company reported on its website.