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AM-Pharma Commences P-II Study Evaluating Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

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AM-Pharma

AM-Pharma Commences P-II Study Evaluating Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

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  • The company has initiated a P-II study assessing ilofotase alfa's (IV) safety and efficacy as a preventive treatment before and after cardiac surgery in patients (n=150) for cardiac surgery-associated renal damage (CSA-RD)
  • The 1EP includes pre- and post-surgery creatinine levels while the exploratory EPs include Major Adverse Kidney Events (MAKE) incidence & severity of post-surgery AKI. The trial will end in Q4’24, with data readout anticipated in early 2025
  • Additionally, Ilofotase alfa showed improved MAKE90 in sepsis-associated AKI across previous P-II & P-III studies and P-III (REVIVAL) trial reported a reduction in MAKE90 events to 57.2% of patients vs 64.7% in PBO. It functions as an enzyme replacement therapy for hypophosphatasia (HPP)

Ref: AM-Pharma | Image: AM-Pharma

Related News:- AM-Pharma Enters into an Exclusive License Agreement with Kyowa Kirin to Commercialize Ilofotase Alfa in Japan 

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Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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