Principal investigator Professor Peter Pickkers to present data at ISICEM on March 21st in Brussels and at the AKI & CRRT conference on March 29th in San Diego

A significant reduction in major adverse kidney events by day 90 and no difference in 28-day all-cause mortality was observed after review of the data from all patients in the study

UTRECHT, The Netherlands–(BUSINESS WIRE)–AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, today announced that Professor Peter Pickkers, M.D., Ph.D., principal investigator of the Phase 3 REVIVAL study, will present data from the study at two upcoming scientific conferences. The data from 650 patients with Sepsis-associated Acute Kidney Injury (SA-AKI), will be featured in presentations at the 42nd International Symposium on Intensive Care & Emergency Medicines (ISICEM) on March 21st in Brussels, Belgium and at the 28th International Conference on Advances in Critical Care Nephrology AKI & CRRT on March 29th in San Diego, CA, USA.

“While a survival benefit was not observed, we demonstrated significant reno-protective effects in SA-AKI patients treated with ilofotase alfa as compared to placebo, which were most pronounced in patients with pre-existing renal impairment. Together with the excellent tolerability profile, these results demonstrate the promising potential of ilofotase alfa as a pharmacological recourse in AKI,” said Professor Peter Pickkers, M.D., Ph.D., Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the REVIVAL study.

The global Phase 3 REVIVAL study assessed the efficacy and safety of ilofotase alfa, AM-Pharma’s human recombinant alkaline phosphatase, in patients with SA-AKI. The study, which recruited SA-AKI patients from 107 sites in Europe, North America, Australia, New Zealand, and Japan, did not reveal any safety concerns but was discontinued for futility based on the primary endpoint of 28-day all-cause mortality after treatment of 650 patients (placebo n=321; ilofotase alfa n=329). A prespecified analysis of the key secondary renal endpoint of Major Adverse Kidney Events by day 90 (MAKE90) indicated a significantly (p=0.031) lower rate of subjects experiencing a MAKE90 event in the ilofotase alfa group (57.2%) compared to the placebo group (64.7 %). This effect was mainly driven by a reduced need for dialysis in the ilofotase alfa treated group.

“Despite missing the primary endpoint, ilofotase alfa has consistently shown that it provides positive effects on kidney function both in our recent Phase 3 REVIVAL study as well as in our Phase 2 STOP-AKI study. The outcomes show that treatment with ilofotase alfa result in substantial long-term benefit for AKI patients, which we plan to investigate further. We look forward to providing further details on our clinical development pathway over the course of 2023,” added Erik van den Berg, Chief Executive Officer of AM-Pharma.

The presentations will focus on ilofotase alfa’s treatment effect on MAKE90, characterized by death up to Day 90, renal replacement therapy (RRT) through Day 28 and on Day 90, >25% drop in eGFR at Day 90, and rehospitalization up to Day 90. The significant beneficial effect observed on MAKE90 was predominantly driven by the decrease in patients requiring RRT (28.2% ilofotase alfa vs 36.4% placebo) and was most pronounced in patients with pre-existing chronic kidney disease (CKD).

Presentation details:

The 42nd International Symposium on Intensive Care and Emergency Medicine (ISICEM), March 21 – 24, 2023, Brussels, Belgium.

Title: Recombinant alkaline phosphatase for renal protection

Date: Tuesday, March 21st, 2023

Time: 3:35 p.m. CET

Location: 400 Hall

The 28th International Conference on Advances in Critical Care Nephrology AKI & CRRT 2023, March 29 – April 1, 2023, San Diego, CA.

Title: Ilofotase alfa exerts renal protective effects in patients with sepsis-associated acute kidney injury.

Date: Wednesday, March 29th, 2023

Time: 5:30 p.m. PT

Location: Main exhibit hall

About the REVIVAL study

The Phase 3 REVIVAL study was a randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase, ilofotase alfa, for the treatment of patients with SA-AKI. Patients in the study were randomized to receive 1.6mg/kg of ilofotase alfa or placebo. The primary endpoint of the study was 28-day all-cause mortality. Secondary endpoints included long-term Major Adverse Kidney Events (MAKE), the use of organ support, length of stay in the ICU and 90-day all-cause mortality. Further information on this study can be found at www.clinicaltrials.gov, NCT04411472 (REVIVAL).

About Ilofotase alfa

Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that in multiple clinical trials was shown to be stable and highly active. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia found in kidney following sepsis or ischemia-induced damage. Research has shown that ATP dephosphorylation has a double effect in protecting against kidney injury. When the pro-inflammatory ATP is dephosphorylated, the resulting adenosine further reduces inflammation through the activation of the immunosuppressive adenosine A2a receptor pathway.

About AM-Pharma

AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is initially being developed for the treatment of patients with acute kidney injury and has been granted FDA fast-track status. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety profile and a demonstrated kidney benefit. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals. Find out more about us online at: www.am-pharma.com.

Contacts

Investors:

Lars Boesgaard, Chief Financial Officer

l.boesgaard@am-pharma.com

Media:

Trophic Communications

Eva Mulder or Priscillia Perrin

+31 6 52 33 15 79

am-pharma@trophic.eu