AM-Pharma B.V. is a clinical-stage biopharmaceutical company developing recAP, a recombinant human alkaline phosphatase therapeutic for acute kidney injury (AKI), particularly sepsis-associated AKI (SA-AKI). recAP has Fast Track designation from the U.S. FDA (awarded in 2016) and the company completed a 301-patient Phase II trial. The planned multinational pivotal Phase III trial aims to enroll up to 1,400 SA-AKI patients at sites in approximately 12 countries. Recent financing is intended to support that Phase III trial and to fund Marketing Authorization Application readiness activities, including CMC validation and commercial manufacture. AM-Pharma has raised additional capital bringing recent fundraising to a total of €163m, enabling the company to advance recAP toward registration and commercialization. The company's investor syndicate includes Cowen Healthcare Investments, the European Investment Bank and earlier backers such as LSP, Andera Partners, Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare. AM-Pharma is a clinical-stage biopharmaceutical company focused on recAP, a recombinant human alkaline phosphatase therapeutic for acute kidney injury (AKI). recAP is a proprietary recombinant human AP constructed from two human isoforms with a dual mechanism of action: dephosphorylation of lipopolysaccharides (LPS) and extracellular ATP to reduce inflammation and protect the kidney. The candidate reported promising Phase II STOP-AKI results in 301 sepsis patients, including a relative reduction in mortality of more than 40% and significant long-term kidney-function improvements; results were published in JAMA. The programme holds FDA Fast Track designation (2016) and the company is preparing a pivotal Phase III study in sepsis-associated AKI to enroll about 1,400 patients across approximately 12 countries. AM-Pharma plans to submit market-authorization applications in the US and Europe following successful completion of the single pivotal Phase III trial. The company is also exploring recAP in other indications including ulcerative colitis, necrotizing enterocolitis and hypophosphatasia. Financially, AM-Pharma has raised over €195m in equity and debt to date and recently secured €116m to support its Phase III programme. AM-Pharma, based in Bunnik, the Netherlands, focuses on the preclinical and clinical development of recombinant human Alkaline Phosphatase (recAP) as a treatment for inflammatory diseases. Its lead program is recAP for acute kidney injury (AKI) related to sepsis; the company also intends development for ulcerative colitis and hypophosphatasia and may pursue an oral formulation for UC. recAP is produced by cGMP manufacture for clinical trials and potential commercialization. Results from the current Phase II trial in AKI were expected in the second half of 2016. AM-Pharma built on positive Phase II data with bovine AP to develop the recombinant human form for future trials and commercialization. Since inception the company has raised €67 million from a syndicate of international investors and completed a €12.2 million financing in September 2014 to support the Phase II study and oral formulation work. AM-Pharma develops recAP, a proprietary recombinant human Alkaline Phosphatase optimized as an injectable for Acute Kidney Injury (AKI) and an oral formulation for Ulcerative Colitis (UC). The company plans to complete a 290‑patient, four‑arm, Phase II dose‑finding, placebo‑controlled, Phase III‑enabling study in AKI and to start Phase II development in UC. Proceeds from the recent financing will also support continued development of an oral recAP formulation. AM-Pharma bases its development on prior positive Phase II results with bovine Alkaline Phosphatase and manufactures recAP to cGMP standards for clinical supply. The company is headquartered in Bunnik, The Netherlands. Financially, AM-Pharma has previously raised €29.2M in Q4 2011 and has now closed an additional €12.2M financing to advance its clinical programs. AM-Pharma focuses on preclinical and clinical development of a human recombinant Alkaline Phosphatase (AP) as a protective treatment for severe inflammatory diseases. The company aims to replace bovine AP with its proprietary recombinant human AP for future trials and commercialization. Clinical proof-of-concept with bovine AP showed positive Phase II results in AKI and a Phase II trial in severe Ulcerative Colitis, supporting the development path. The current plan is to finalize GMP production of the recombinant AP and advance it through the end of Phase II. Management highlights the high unmet medical need in AKI, a market the article values at roughly USD 2 billion with over 700,000 annual deaths. AM-Pharma is based in Bunnik, The Netherlands.

Total raised

$325M

Funding rounds

6

Latest round

Debt Financing

Latest activity

Mar 2020