companies

AM-Pharma

Founded 2001
Employees 40+
Primary contact
Stadsplateau 6
3521 AZ Utrecht
Netherlands
+ 31 (0)30 228 92 22
Links
https://www.am-pharma.com/
Diseases & Conditions
Sections
AM-Pharma is a clinical-stage biopharmaceutical company developing a treatment for sepsis-associated acute kidney injury (SA-AKI) - recombinant human alkaline phosphatase therapeutic. The company is focused on the successful execution of its Phase III REVIVAL pivotal trial while continuing to build an organization committed to using its insight and knowledge for other severe medical conditions, including other kidney diseases, sepsis and organ injury-related indications.
Select partners: Kyowa Kirin, KBI.
Founded 2001
Employees 40+
Primary contact
Stadsplateau 6
3521 AZ Utrecht
Netherlands
+ 31 (0)30 228 92 22
Links
https://www.am-pharma.com/
Diseases & Conditions
Sections

Funding 💰

Total $241.6M
Select investors Idinvest Partners, Forbion, Kurma Partners, Ysios Capital, Gilde Healthcare, EQT Life Sciences, Andera Partners, European Investment Bank, Eurazeo

Key people 🧑‍🤝‍🧑

Highlights ⭐

  • Bold goal: AM-Pharma's initial focus is sepsis-associated acute kidney injury (AKI), which is the cause of death for hundreds of thousands of people hospitalized each year. Depending on the severity and cause of renal injury, mortality ranges from 10% to as high as 60%. In the US alone, hospitals spend around $10 billion each year on managing this major medical problem. 🔗
  • Proprietary tech: AM-Pharma's proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury. Constructed from two human isoforms of alkaline phosphatase, it has been demonstrated in multiple clinical trials to be stable and highly active. 🔗
  • Phase II study: The STOP-AKI (Sepsis Trial Of alkaline Phosphatase in Acute Kidney Injury) trial was a safety, tolerability, efficacy and QoL study of human recAP in the treatment of patients. It demonstrated a significant relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. 🔗
  • Phase III: The REVIVAL trial is a Phase III pivotal, randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center study evaluating the efficacy and safety of AM-Pharma's proprietary recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. Target enrolment of up to 1,400 patients and data on the primary endpoint of 28-day all-cause mortality are expected in 2023. 🔗

Video ▶️

Awards & Recognitions 🏆

  • 2016 CARE Awards: Most Innovative Clinical Trial Design 🔗
  • 2015 Scrip Awards: Best Partnership Alliance for AM-Pharma and Pfizer 🔗

Quotes 💬

“
As an organization centered around research, development and partnerships with innovative drug discovery organizations around the globe, we are excited to initiate this relationship with AM-Pharma to potentially improve the lives of patients and families affected by sepsis-associated acute kidney injury. Ilofotase alfa has demonstrated its therapeutic potential in AM-Pharma's Phase II STOP-AKI study, and we look forward to being a strategic partner supporting the commercialization and thereby patient access of ilofotase alfa upon successful completion of the pivotal REVIVAL study.
— Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin 🔗
“
AM-Pharma has completed a robust 301 patient Phase II trial in SA-AKI, following a clear path based on regulatory feedback and the team has significant expertise in the field of acute kidney injury. We believe that recAP has the potential to be an important treatment option for AKI and other indications of high unmet medical need. We look forward to working with the team and the rest of the investors throughout the Phase III trial and beyond.
— Tim Anderson, Managing Director at Cowen Healthcare Investments 🔗
“
We have been following the AM-Pharma story for some time and are delighted to have the opportunity to co-lead this financing round. With its promising Phase II recAP data published last year, this is an exciting time to support the Company as it is poised and ready to start the Phase III clinical study. recAP has the potential to become the first pharmacological treatment and a blockbuster first-line therapy for critically ill patients with SA-AKI.
— Martijn Kleijwegt, Managing Partner at LSP 🔗
“
We were very impressed with the concept-to-clinic work that AM-Pharma has carried out. This includes the development and cGMP manufacture of recAP, gaining an understanding of its mechanism of action, designing and running an adaptive Phase II clinical trial and, most importantly, its positive impact on patients with SA-AKI. On this journey AM-Pharma has matured from a start-up to a clinical-stage biopharmaceutical company with an in-depth understanding of the underlying and complex causes of AKI. We look forward to these valuable insights translating to future treatment for patients with renal and other diseases of high unmet medical need.
— Raphaël Wisniewski, Partner at Andera Partners 🔗
Last update: March 10, 2023