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news.The US Food and Drug Administration (FDA) has approved Neovacs' investigational new drug application to extend its ongoing Phase IIb clinical trial of IFNα Kinoid to treat Lupus.
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The phase IIb trial is a global multicentric study, randomized versus placebo, started in October last year in Lupus.
It intends to assess the biological and clinical efficacy of the IFNa Kinoid in patients with a moderate to serious form of Lupus disease.
The trial, which will last for 18 months, will enroll 178 patients in 19 countries across Europe, Asia, Latin America, and the US.
Neovacs CEO Miguel Sieler said: "This clearance by the FDA is a real success for Neovacs and will allow us to extend our actual trial to American investigators and patients.
"The FDA has given this approval within the regulatory time frame which demonstrates the complete and convincing character of our file."
The IFNa-Kinoïd is an anti interferon alpha (IFNa) therapeutic vaccine developed to treat lupus or systemic lupus erythematosus.
Neovacs has demonstrated that the self antibodies produced by administration of the IFNa-Kinoïd neutralize all 13 sub-types of IFNa in the serum of lupus patients.
The company said the activity supports the positioning of its therapeutic vaccine as a next-generation treatment for the disease.
A phase I/II clinical trial of IFNa-Kinoïd in lupus patient was carried out in 2010-2011.
Neovacs is looking for potential partners to continue clinical development of IFNa-Kinoïd.