Positive Phase III trial results for AstraZeneca in flushing copper from tissues

pharmafile | August 26, 2021 | News story | |   

AstraZeneca’s ALXN1840 demonstrated approximately three times greater copper mobilisation from tissues than standard-of-care treatments.

Results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments.

ALXN1840, a potential new once-daily, oral medicine, demonstrated approximately three times greater copper mobilisation than SoC.

The trial enrolled 214 patients, including treatment-naïve participants and those who have been on SoC therapy for an average of ten or more years.

Additional analyses, including individual patient-reported outcomes and clinician-reported functional assessments, are ongoing and will be presented at an upcoming medical meeting.

Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised. Damage from toxic copper build-up in tissues and organs leads to liver disease, psychiatric, and/or neurological symptoms.

Marc Dunoyer, Chief Executive Officer, Alexion, said: “Where existing treatments remove copper from the blood, these 48-week Phase III results demonstrate ALXN1840’s significant impact in mobilising copper from tissues.

“As we advance this first innovation in Wilson disease treatment in more than 30 years, we will continue to follow these patients long term to further assess clinical impact on disease symptoms.

“We look forward to learning more about how we can evolve the treatment of this progressive and devastating disease.”

Dr Michael Schilsky, Medical Director of Adult Liver Transplant at Yale-New Haven Transplantation Center, Yale University, New Haven, Connecticut, US and principal investigator of the FoCus Phase III trial, said: “It is encouraging to see the effect of ALXN1840 on both treatment-naïve patients and those who have been on SoC for an average of ten or more years.

“The Phase III results provide evidence that tissue-bound copper remains built-up in the organs even in patients who have been on SoC therapy for many years, and the potential for ALXN1840 to provide a new approach to mobilise and safely sequester copper from tissues.”

Lilly Subbotin

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