The U.S. Food and Drug Administration (FDA) has granted fast-track status to Neovacs’ vaccine IFNα Kinoid, which is being evaluated as a treatment for systemic lupus erythematosus (SLE).
The vaccine is aimed at blocking interferon alpha, or IFNa, a protein linked to lupus. The more IFNa that patients have, the more severe their disease is likely to be, scientists have found.
Neovacs has recruited half of the 178 patients it wants for a 36-week Phase 2b trial (IFN-K 002, NCT02665364) to evaluate IFNα Kinoid’s impact on those with moderate to severe lupus.
A key objective of the study will be to see how patients respond to the vaccine. SLE Responder Index (SRI)-4 response criteria will be the assessment instrument.
Another objective will be to assess changes in interferon-activated genes between the start and end of the study.
Participants will come from the U.S. and 20 countries in Europe, Asia, and Latin America.
Fast-track status can help patients gain quicker access to new therapies. The FDA grants the status to treatments for serious or life-threatening diseases in cases where there is an unmet medical need.
The designation speeds up treatments’ development, allowing companies to meet frequently with the FDA to review development progress and the design of clinical trials. In addition, fast track allows companies to submit parts of their New Drug Application for review as clinical data becomes available.
“This Fast Track designation reinforces our confidence in the therapeutic potential of IFN Kinoid as a treatment for Lupus,” Therese Croughs, chief medical officer of Neovacs, said in a news release. “Today, the available treatments only aim to reduce the inflammation, to alleviate the symptoms and are associated with significant side effects.”
“This announcement follows the [Investigational New Drug application] obtained in April this year,” added Miguel Sieler, Neovacs’ CEO. “It is the second favorable notification by the FDA to Neovacs in the course of 2016. We are proud to receive once again from the FDA the confirmation of the innovative character of our therapeutic approach.”