ImmuPharma submits IPP-201101 IND to FDA

UK-based drug discovery firm ImmuPharam says it has submitted an Investigational New Drug application for its developmental lupus erythematosus treatment IPP-201101 to the US Food and Drug Administration. The firm is requesting clearance to conduct a Phase II/III trial.

The submission follows on from a Phase II trial in which IPP-201101 demonstrated clinical efficacy in lupus patients. The proposed study will seek to recruit 240 subjects and will be conducted at sites in the USA, Europe and Latin America. ImmuPharma said that, assuming the program confirms the earlier efficacy findings, it will aim to submit the drug for FDA fast-track review with the aim of gaining marketing approval at the end of 2009.