AM-Pharma Completes Enrollment in Phase 2 Study of Ilofotase Alfa for Prevention of Cardiac Surgery-Associated Renal Damage
created: Oct. 2, 2025, 9 a.m. | updated: Oct. 3, 2025, 5:04 p.m.
Utrecht, The Netherlands, October 2, 2025 – AM-Pharma B.V. today announced that it has successfully completed enrollment of patients in its ongoing Phase 2 clinical trial evaluating ilofotase alfa for the prevention of cardiac surgery-associated renal damage (CSA-RD).
CSA-RD, a common cause of Acute Kidney Injury (AKI), is a serious complication of cardiac surgery occurring in up to 40% of patients.
MAKE60 is an FDA-registrable endpoint, which would serve as the primary endpoint in the expected pivotal Phase 3 trial for ilofotase alfa.
Dephosphorylation of ATP by ilofotase alfa provides dual reno-protective benefits: clearance of pro-inflammatory ATP and generation of adenosine, which activates the tissue-protective adenosine A2a receptor pathway.
We also develop ilofotase alfa in the severe rare disease HPP where ilofotase alfa has orphan drug status in the US and EU.
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