argenx announces “GO” Decision in ADHERE trial of Efgartigimod in Chronic Inflammatory Demyelinating Polyneuropathy following interim analysis
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, announced its plan to continue enrollment in the ADHERE trial evaluating subcutaneous (SC) efgartigimod (co-formulated with Halozyme's ENHANZE® drug-delivery technology) in chronic inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial is expected to enroll approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.
“Following our review of the interim ADHERE data and confirmation from the data monitoring committee, we are confident in our decision to continue with enrollment. We relied on key learnings from precedent CIDP trials in defining our go-forward thresholds and are excited to have cleared this first hurdle on the path to registration of efgartigimod in CIDP,” commented Wim Parys, M.D., Chief Medical Officer of argenx. “CIDP is now the fourth autoimmune disease that we selected based on its solid biological rationale where we have demonstrated clinical proof-of-concept, further emphasizing the broad applicability of efgartigimod. We hope to be able to offer a new potential treatment to CIDP patients who have limited therapeutic options for this severe, progressive disease.”
The “GO” decision was based on a planned efficacy and safety assessment following the enrollment of 30 patients into the initial part of the ADHERE trial. The interim analysis achieved the pre-defined threshold for continuation, which was based on response rates seen in precedent clinical trials of current standard of care in CIDP. The decision to continue enrollment was confirmed by an independent data monitoring committee. In addition, the tolerability profile observed to date is consistent with that of efgartigimod in other clinical trials.