Therapy Areas: Autoimmune
ChemoCentryx, Partners Withdrawl Phase II-Based Conditional Marketing Authorisation Application for ANCA-Associated Vasculitis in Europe, Phase III Advocate Trial Data Release Planned for 4Q19
25 January 2019 - - US-based biopharmaceutical company ChemoCentryx, Inc. (NASDAQ: CCXI) and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Switzerland-based Vifor Pharma Group, have decided to withdraw the application for Conditional Marketing Authorisation of avacopan for the treatment of ANCA-associated vasculitis based on Phase II data, the principals said.

The principals said they are taking this action in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis)

Efforts will now be exclusively directed to file integrated regulatory submissions in 2020 with the European Medicines Agency and United States Food and Drug Administration for full (unconditional) marketing approval, after the planned release of topline data from the Phase III ADVOCATE clinical trial anticipated already in the fourth quarter of 2019.

Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. Avacopan is in Phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA-associated vasculitis).

In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while allowing elimination of high-dose steroids, part of the current standard of care. 

ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy and hidradenitis suppurativa. The US Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated Vasculitis, C3G and atypical hemolytic uremic syndrome. 

The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G.

Avacopan was also granted access to the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) initiative, which supports accelerated assessment of investigational therapies addressing unmet medical need.

ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialise avacopan and CCX140 in markets outside of the US ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become a leader in iron deficiency, nephrology and cardio-renal therapies.

The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions.

Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care.

Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is headquartered in Switzerland.

Vifor Fresenius Medical Care Renal Pharma is a common company of Vifor Pharma Group and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease worldwide.

The company was founded at the end of 2010 and is owned 55% by Vifor Pharma Group and 45% by Fresenius Medical Care.

ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. 

ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialise orally-administered therapies. ChemoCentryx is currently focusing on its late stage drug candidates for patients with rare diseases, avacopan (CCX168) and CCX140.

CCX140 is an inhibitor of the chemokine receptor known as CCR2 and is currently being developed for patients with focal segmental glomerulosclerosis, a debilitating kidney disease.

The US Food and Drug Administration has granted CCX140 orphan-drug designation for the treatment of FSGS.
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