Phase 2 Trial of Neovacs’ Lupus Interferon Immunotherapy Receives Another Review Board Sign-off

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by Magdalena Kegel |

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Neovacs’ Phase 2b clinical trial of an interferon immunotherapy for lupus is going according to plan, the company announced after an independent review board declined to recommend modifications to the study.

The trial is evaluating interferon (IFN)-alpha kinoid immunotherapy as a treatment for systemic lupus erythematosus.

One hundred seventy-eight patients with moderate or severe lupus are taking part in the trial (NCT02665364). That was the number researchers wanted, so enrollment was halted in June 2017.

Participants are being randomly assigned to receive either injected IFN-alpha kinoid or a placebo. Researchers are assessing the therapy’s effectiveness 36 weeks after treatment. They are using a number of evaluation tools, including a British Isles Lupus Assessment Group scale.

Researchers are also tracking the treatment’s safety.

The trial is running in 21 countries in North America, Latin America, Asia, Europe, and North Africa.

It was the third time that the independent review board had signed off on the trial’s safety and other considerations.

“We are pleased with this favorable IDSMB [board] decision, which comes following completion of patient enrollment,” Thérèse Croughs, Paris-based Neovacs’ chief medical officer, said in a press release. All of the patients have been followed for nine months, and the company’s plans to report the trial results in the second quarter of 2018, she added.

The company updated its preliminary trial findings at the Keystone Symposia in Banff, Canada, March 19-23.

Neovacs’ kinoid technology is a type of immunotherapy that acts as a vaccine against cytokines, the scientific name for inflammatory proteins.

Cytokine production malfunctions are a hallmark of several autoimmune and inflammatory diseases, including lupus.

IFN-alpha kinoid suppresses IFN-alpha, a cytokine that lupus patients produce in excessive amounts. High levels of the protein cause inflammation and an imbalance in immune processes.

The kinoid triggers an immune response in which the body produces antibodies that target IFN-alpha, preventing the cytokines from causing harm.

South Korea, where five centers are involved in the Phase 2 trial, is also playing a role in the therapy’s development. Neovacs partnered with BioSense Global to develop the treatment in China.

The country recently granted the company a patent on the therapy. The patent gives the company marketing protection in the country until 2032.