AM-Pharma BV
AM-Pharma is a clinical stage biopharmaceutical company dedicated to developing treatments for severe medical conditions such as kidney disease, sepsis, and organ injury. Their proprietary recombinant human alkaline phosphatase, ilofotase alfa, has shown promise in clinical trials and is currently in pivotal Phase III trials for sepsis-associated acute kidney injury (SA-AKI). The company aims to bring innovative treatment options to critically ill patients worldwide, with ongoing collaborations and licensing agreements, including partnerships with Kyowa Kirin for the Japanese market. Their research demonstrates the potential of ilofotase alfa to reduce mortality and protect against renal inflammation, positioning them as a leader in addressing unmet medical needs.
Industries
Nr. of Employees
small (1-50)
Products
Recombinant human alkaline phosphatase therapeutic (recombinant enzyme biologic)
Intravenous recombinant human alkaline phosphatase engineered from human isoforms, developed as a therapeutic enzyme to dephosphorylate extracellular inflammatory substrates and reduce organ inflammation and injury.
Recombinant human alkaline phosphatase therapeutic (recombinant enzyme biologic)
Intravenous recombinant human alkaline phosphatase engineered from human isoforms, developed as a therapeutic enzyme to dephosphorylate extracellular inflammatory substrates and reduce organ inflammation and injury.
Services
Global pivotal clinical trial conduct
End-to-end management of late-stage multi-center randomized controlled trials, including protocol execution, site activation, enrollment management and interim analyses.
Biomarker and PK/PD clinical assessments
Design and execution of clinical biomarker studies and PK assessments to demonstrate target engagement and support dose selection in clinical development.
Preclinical efficacy and mechanism-of-action studies
In vivo pharmacology and translational studies to demonstrate mechanism-of-action and organ-protective effects in acute injury models.
CMC, manufacturing scale-up and supply-chain planning
Process development, closed CMC planning and supply-chain management to support large multicenter trials and commercial readiness for biologic therapeutics.
Regulatory affairs and quality management
Regulatory planning, agency engagement and quality management support for multi-region clinical programs, including preparation for regulatory submissions and designation attainment.
Real-world data analysis to inform trial design
Retrospective EHR analyses to evaluate incidence, staging and outcomes to support endpoint selection and prognostic enrichment for clinical trials.
Global pivotal clinical trial conduct
End-to-end management of late-stage multi-center randomized controlled trials, including protocol execution, site activation, enrollment management and interim analyses.
Biomarker and PK/PD clinical assessments
Design and execution of clinical biomarker studies and PK assessments to demonstrate target engagement and support dose selection in clinical development.
Preclinical efficacy and mechanism-of-action studies
In vivo pharmacology and translational studies to demonstrate mechanism-of-action and organ-protective effects in acute injury models.
CMC, manufacturing scale-up and supply-chain planning
Process development, closed CMC planning and supply-chain management to support large multicenter trials and commercial readiness for biologic therapeutics.
Regulatory affairs and quality management
Regulatory planning, agency engagement and quality management support for multi-region clinical programs, including preparation for regulatory submissions and designation attainment.
Real-world data analysis to inform trial design
Retrospective EHR analyses to evaluate incidence, staging and outcomes to support endpoint selection and prognostic enrichment for clinical trials.
Expertise Areas
- Late-stage clinical trial management (Phase II–III)
- Adaptive trial design and interim/futility analysis
- Clinical data management and biostatistics
- Biologics CMC and manufacturing scale-up
Key Technologies
- Recombinant protein therapeutics
- Enzyme engineering (chimeric human isoform constructs)
- Biomarker assays (e.g., PLP, inorganic pyrophosphate)
- Rodent ischemia-reperfusion AKI models