The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.
Miguel Sieler, CEO of Neovacs, commented: “FDA clearance of a new IND application is an important milestone for the development of our IFNalpha Kinoidtechnology. The data obtained in lupus with IFNalpha Kinoid have been positively evaluated by FDA, which supports the application of our vaccine in dermatomyositis. Therefore, we are focused on advancing IFNalpha Kinoid through the clinic, as expeditiously as possible, in the context of an orphan disease with a high unmet medical need. We are excited about expanding this clinical trial to the United States, where many renowned investigators have expressed their interest in our technology.”
Neovacs noted that this Phase IIa clinical trial is a multicenter study currently being conducted in Europe (France, Italy, Germany, and Switzerland) in 30 adult patients. The objective of the study is to evaluate the immunogenicity, tolerability, and biological and clinical efficacy of IFNalpha Kinoid in this new indication. The results of this study are expected to support the design and execution of a pivotal study, the company said.