Phase 3 registration trials with Nefecon are being planned following the successful completion of a placebo-controlled randomized Phase 2b study (the NEFIGAN Trial), which met its primary efficacy endpoint.
Nefecon acts through a mechanism that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the GI tract plays in the overall immune response.
Promising results indicate that treatment with Nefecon may provide clinical benefits to IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon has been granted orphan drug designation by the US Food and Drug Administration (FDA).
Pharmalink is also investigating further indications where Nefecon may have potential to address unmet medical needs.