AM-Pharma Announces Two Presentations at the 27th International Conference on Advances in Critical Care Nephrology
AM-Pharma B.V., an emerging leader focused on developing therapeutics for severe medical conditions, today announced two presentations at the 27th International Conference on Advances in Critical Care Nephrology in San Diego, CA. In the oral presentation at 11:30 a.m. on Thursday, March 10, 2022, Dr. Peter Pickkers, Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Center, will provide an overview of AM-Pharma’s ongoing Phase 3 REVIVAL study. The second presentation is a poster with new data supporting the importance of managing acute kidney injury (AKI) in patients undergoing cardiac surgery, which will be presented today.
Poster Presentation: Effect of AKI Stage on Clinical Outcomes and Residual Renal Function in Adult Patients Undergoing On-Pump Cardiac Surgery
The poster presentation contains data from a retrospective study that assessed more than 6,800 patients having undergone cardiac surgery and found that patients with AKI were significantly more likely to experience a Major Adverse Kidney Event within 90 days (MAKE90). Major Adverse Kidney Events is a potential endpoint for phase 3 studies in acute kidney disease as it includes three important patient outcome components: death, new onset dialysis and sustained reduction in kidney function. The full data from this study was presented in a poster today at the 27th International Conference on Advances in Critical Care Nephrology in San Diego, California.
This study was a retrospective analysis of electronic medical records from the Cerner® Real-World Data database of adult U.S. patients from January 1, 2016, to December 31, 2020. The authors reviewed records from approximately 22,000 cardiac surgery patients and 6,821 met the inclusion criteria for this study. For each patient included in the study, the authors reviewed the incidence and stage of AKI 5 days post-surgery, the patients’ eGFR and the incidence of MAKE90 events. Of the 6,821 patients in this study, 3,416 experienced no AKI and 3,405 experienced AKI post-surgery. The presence of acute kidney injury post-surgery was associated with significantly more MAKE90 events, with 28.7% of patients with AKI having experienced a MAKE90 event compared to only 7.8% of patients with no AKI. Additionally, 747 patients were categorized with more severe AKI (AKI stage 2/3) and those patients suffered even worse outcomes, with nearly 70% experiencing a MAKE90 event. In addition, the data demonstrate that the kidney function as assessed by eGFR within the 90 days interval was profoundly reduced when the patients developed severe AKI.
“These data are important to AM-Pharma as we seek to initiate a phase 3 study for ilofotase alfa this year to mitigate the risk of AKI in cardiac surgery patients,” said Maarten Kraan, M.D, Ph.D., Chief Medical Officer of AM-Pharma. “Up to 30% of patients undergoing cardiac surgery suffer from concomitant AKI. We believe that better management of Cardiac Surgery Associated-AKI may significantly improve outcomes for these patients.”
Andrew Shaw, M.D., Chairman, Department of Intensive Care and Resuscitation at The Cleveland Clinic and primary author on this study, commented, “The data from this study highlight the importance of acute kidney injury in the setting of cardiac surgery, and demonstrate the extent of the unmet medical need in this disease space. The MAKE composite endpoint is important because it includes three components of critical importance for patients: death, new onset dialysis and sustained reduction in kidney function. The incidence of MAKE90 in patients who developed AKI after the surgery was 28.7% - so one in 3-4 patients – and even higher in moderate to severe AKI with 7 out of 10 patients positive for MAKE.”
About Ilofotase Alfa
Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that was shown in multiple clinical trials to be stable and highly active. Systemic administration of ilofotase alfa demonstrated potent inhibition of acute inflammation in kidney, lungs, liver, gut and other organs resulting in survival improvement of critically ill patients. 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, lung and liver 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.
AM-Pharma’s purpose is to save and improve the lives of patients confronted with severe medical conditions. Our initial focus is sepsis-associated acute kidney injury, the cause of death for hundreds of thousands of people hospitalized each year. Our proprietary compound, ilofotase alfa, has the potential to become the first treatment for sepsis-associated acute kidney injury and is now in a global pivotal Phase III clinical trial. 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Gretchen Schweitzer or Eva Mulder
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Starr Insurance Companies Expands in Thailand17.5.2022 22:33:00 CEST | Press release
Starr Insurance Companies (Starr) announced an agreement with FPG Insurance Holdings Limited (HK) (FPG) and local Thai shareholders to purchase FPG Insurance Public Company Limited (FPG Thailand), a Thai non-life insurance company, together with local Thai parties. Starr’s investment will be held by its Bermuda insurance company, Starr Insurance & Reinsurance Limited. The transaction is expected to close in the second quarter of 2022, subject to certain customary closing conditions, including any necessary regulatory approvals. “Thailand is an important, fast-growing insurance market — one of the cornerstones of the Southeast Asia economy,” said Maurice R. Greenberg, Starr’s Chairman & CEO. “Asia is both commercially and culturally important to Starr, as we trace our roots to an American-owned company founded in Shanghai more than 100 years ago. We look forward to serving the needs of local Thai companies and consumers through this new insurance capability.” David Zuellig, FPG regional
Emendo Biotherapeutics’ next generation CRISPR gene editing technologies achieve breakthrough results with allele-specific approach for ELANE -related Severe Congenital Neutropenia as presented at ASGCT Annual Meeting17.5.2022 22:15:00 CEST | Press release
Emendo Biotherapeutics presented the results of its next generation CRISPR-based gene editing approaches for several indications in an oral presentation and three posters at the 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) held May 16-19, 2022, in Washington, D.C. Emendo presented pre-clinical data for the treatment of ELANE-related Severe Congenital Neutropenia using an allele-specific editing approach, demonstrating the power of Emendo’s dual technology platforms that enable the development of a highly specific editing composition that demonstrates no off-targets and complete allele specificity. Significantly, the lack of off-target achieved by Emendo’s engineered and optimized OMNI nuclease also eliminated any translocations. Edited patient derived CD34+ cells differentiated normally into neutrophils both in-vitro and in-vivo, showing full engraftment and reconstitution of all blood lineages, as required for the desired therapeutic effect. “ELANE-based
Piper Sandler Advises PETRONAS Chemicals Group Berhad on Acquisition of Perstorp17.5.2022 19:59:00 CEST | Press release
Piper Sandler & Co. chemicals investment banking announced today that it has advised PETRONAS Chemicals Group Berhad (PCG) on its acquisition of Perstorp Holding AB. The transaction Enterprise Value is €2,300 million and base purchase price, less adjusted net debt, is €1,538 million. It is expected to close in Q3 2022 subject to customary closing conditions. PCG is the leading integrated chemicals producer in Malaysia and one of the largest in Southeast Asia. It operates a number of world-class production sites, which are fully vertically integrated from feedstock to downstream end-products. With a total combined production capacity of 12.8 million metric tons per annum (mtpa), it is involved primarily in manufacturing, marketing, and selling a diversified range of chemical products, including olefins, polymers, fertilizers, methanol and other basic chemicals and derivative products. Listed on Bursa Malaysia in 2010 and with more than three decades of experience in the chemicals indust
Morinaga Milk Obtains the Registration of "New Food Ingredient" in China for Use of Its Probiotic Bifidobacterium longum BB536 in Infant and Toddler Foods17.5.2022 19:53:00 CEST | Press release
Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced its proprietary probiotic Bifidobacterium longum BB536 was approved by the National Health Commission (NHC) of the People’s Republic of China as a new food ingredient for use in infant and toddler foods (under the age of three) on 11th May 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220517005112/en/ Morinaga Milk obtains the registration of "New Food Ingredient" in China for use of its probiotic Bifidobacterium longum BB536 in infant and toddler foods on 11th May 2022. (Graphic: Business Wire) Following a complex and lengthy registration process, the probiotic strain B. longum BB536 meets the highest standards of safety and regulatory compliance and has now completed the approval process for use as an ingredient in infant and toddler milk and food products for children under three years old in China. “We are extr
Hiro Capital Joins Knollwood and Boost VC With Major Investment in Skybound Entertainment17.5.2022 19:30:00 CEST | Press release
Hiro Capital has invested in Skybound Entertainment in a significant, undisclosed round led by Knollwood Advisory with participation from Boost VC, and follow-on participation from Com2uS and Skydance Entertainment. Skybound Entertainment is home to acclaimed franchises including The Walking Dead, Invincible, and Impact Winter. “There is nothing more powerful than storytelling, and I’m delighted that Hiro has been able to invest in Skybound Entertainment, creators and curators of extremely compelling omniverses,” said Sir Ian Livingstone, Co-Founding Partner of Hiro Capital. “Hiro’s trust in our vision will help us accelerate the evolution of existing hit franchises as well as new content for our fan base around the world,” said Skybound CEO David Alpert. Skybound brings together creators across its multi-faceted business, including comics, interactive games, audio, film, and television (traditional and digital platforms), licensing, and merchandising. Skybound has successfully franchi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom