Bovine intestinal alkaline phosphatase(Alloksys Life Sciences BV)

Examination of sub-population data, with patient stratification, demonstrated promising results, despite interim analysis on the entire patient cohort not revealing significant differences between the RESCAP® and placebo groups for all endpoints Specifically, among patients with a normal renal filtration rate before cardiothoracic surgery, those who received RESCAP® achieved hemodynamic stability 30% sooner and experienced a 70% reduced likelihood of post-surgery acute kidney injury Follow-up Phase III Study with RESCAP® to commence in Q3 2023, with anticipated further accelerated recovery and reduced other complications for all enrolled patients, due to longer administration RESCAP® has the potential to significantly change the approach to critical care in the perioperative periods of major surgeries, resulting in reduced healthcare costs and enabling patients to recover and resume their lives more quickly WAGENINGEN, Netherlands, Aug. 24, 2023 /PRNewswire/ -- Alloksys Life Sciences, a clinical stage biotech company specializing in the development of critical care medicines, today announced interim results from its APPIRED-III study. The phase IIb trial focused on evaluating the efficacy of RESCAP® (REScuing Alkaline Phosphatase) in 271 patients undergoing cardiothoracic surgery. The results demonstrate a substantial decrease of around 30% (p < 0.001) in the duration needed to achieve stable blood flow or hemodynamic stability in patients with a normal renal filtration rate before surgery (CKD ≤ 2) who were administered RESCAP® compared to placebo. Moreover, RESCAP® exhibited a 70% reduced probability (p < 0.05) of post-surgical acute kidney injury in these patients. The prospective, randomized, double-blind, and placebo-controlled study was conducted in multiple centers in Europe and the Asia/Pacific region. The subgroup with a normal renal filtration rate that clearly benefited from RESCAP® administration, constituted approximately 50% of the total cohort. These outcomes warrant a follow-up clinical phase III trial with a total of 400 patients, to commence Q3 2023. Ruud Brands, Founder and CEO of Alloksys, comments on the interim results of the APPIRED-III study, which focuses on patients undergoing cardiothoracic surgery. He stated: "We are encouraged that the interim results of our APPIRED-III study demonstrate a positive impact of RESCAP® on recovery of a subgroup of patients. Based on these findings, we anticipate that by extending the administration of RESCAP® in the planned phase III follow-up trial, it will also prove to be effective for patients with more severe chronic kidney disease before surgery. We firmly believe that the RESCAP® intervention has the potential to really impact critical care practices during and after major surgeries. The ability of RESCAP® to expedite recovery may prove to be a major breakthrough in critical care applications." APPIRED III trial APPIRED III is a prospective, randomized, double-blind, and placebo-controlled study involving patients undergoing cardiopulmonary bypass-supported heart surgery, conducted in multiple centers across Europe and the Asia/Pacific region. Prior to surgery, patients received a bolus of 1000 IU of RESCAP® or placebo, followed by a 24-hour infusion with 9,000 IU or placebo. The primary aim of the study was to compare the mortality, morbidity and complications between the administration of alkaline phosphatase versus placebo, with the primary composite endpoint being to demonstrate a reduction in the incidence and extent of acute kidney injury (AKI) after cardiothoracic surgery. While these endpoints were not found for the total patient cohort in this phase IIb trial, the subgroup of patients with normal renal filtration rate did show the aimed for reduction in AKI. Upcoming Phase III trial and market access Alloksys anticipates that in the upcoming phase III trial, with longer administration of RESCAP® (up to 96 hours), benefits such as accelerated recovery and reduced acute kidney injury is expected in all patients (CKD ≤ 3) to be enrolled, further confirming the results of the phase IIb trial. After conducting the planned phase III trial, of which enrollment is expected to commence in Q3 2023, Alloksys plans, preferably with a strategic partner, to prepare a New Drug Application (NDA) and/or Marketing Authorization Application (MAA) for RESCAP® in the US and/or EEA, followed by introduction to the market as a critical care medicine. Substantial demand for effective critical care therapies The multi-billion-dollar critical care medicine market relevant for Alloksys' RESCAP® solution, is a vital and fast-growing segment of the global healthcare industry, focused on diagnosing and managing life-threatening illnesses and injuries. This specialized branch of medicine deals with critical cases, including (septic) shock, burns, accidents, complex (e.g. cardiothoracic) surgeries, sepsis, and severe respiratory problems. The treatment is usually administered in extreme costly intensive care units (ICUs) or trauma centers, where patients receive round-the-clock monitoring and specialized medical attention. These therapies are essential in stabilizing patients, managing symptoms, and improving overall outcomes in critical care situations. The prevalence of conditions like sepsis and acute respiratory distress syndrome has been increasing, especially in older adults and patients with compromised immune systems or chronic health conditions. This escalation in critical illnesses has created a substantial demand for effective pharmaceutical therapeutics that can address these life-threatening medical emergencies. Additionally, the aging global population is a key demographic factor impacting the market. The elderly population is more susceptible to critical illnesses, and their growing numbers have heightened the need for specialized medications tailored to their unique healthcare requirements. As the proportion of older adults increases worldwide, the demand for critical care pharmaceutical therapeutics is expected to grow significantly. Moreover, advancements in medical research and technology have contributed to the development of innovative therapeutics. These advancements, like RESCAP® by Alloksys, could further lead to improved patient wellbeing following major surgery due to improved treatment outcomes and ultimately in reductions in healthcare costs. RESCAP® RESCAP® (RESCuing Alkaline Phosphatase), is a proprietary medication developed by Alloksys, based on the enzyme alkaline phosphatase (AP). AP is naturally present in the body and plays a role in the innate immune system, acting as a "first line of defense." The medication targets and neutralizes circulating inflammation-triggering moieties (ITMs), reducing overall inflammation in the body. By modulating the inflammatory response and supporting native alkaline phosphatase activity at membrane barriers, RESCAP® helps maintain tissue integrity and function, promoting faster recovery. Thus, RESCAP® holds promise as a potential therapeutic agent for various inflammatory conditions and critical care settings. RESCAP® is derived from calf intestines and has been demonstrated to be safe and suitable for intravenous administration in humans. Alloksys has a secured supply of bovine intestinal alkaline phosphatase, which can be scaled up for production. About Alloksys Alloksys is a Dutch, Wageningen, based biotech company with a track record of over 20 years dedicated to preclinical and clinical research in understanding the role of alkaline phosphatase in the innate immune system. This extensive research has led to the accumulation of a vast knowledge base on the pharmacology, safety, production/purification, and pharmaceutical aspects, including dosing and formulation, of this essential enzyme. Alloksys' main focus and drive is the development of a supplementation-strategy with alkaline phosphatase for patients prior to, during and after ischemic insults. The company strongly believes in AP's potential to be very beneficial for patients in need of critical care. This unwavering conviction, coupled with the genuine desire to make a positive impact, has been the driving force behind the company's sustained existence. Alloksys has demonstrated its commitment to its mission by prioritizing the research and development efforts over monetary gains. The team's readiness to embrace salaries that deviate from the norm in the market has guaranteed sufficient funds to propel their pioneering research forward. Alloksys' deep understanding of alkaline phosphatase's mechanism of action, safety profile, and optimal production and purification methods has positioned the company as a potential leader in critical care therapeutics. The company's dedication to continuous research and development has made it a pioneer in exploring the potential benefits of alkaline phosphatase supplementation in treating patients in critical need. As a biotech company, Alloksys, together with its sister company AMRIF (focusing on AP for chronic diseases) stands apart due to its unwavering dedication to making a difference in patients' lives. With a strong commitment to advancing critical care therapies and a wealth of knowledge in the field, Alloksys continues to be at the forefront of innovative and impactful medical solutions. For more information about Alloksys and RESCAP®, please visit . Follow us on LinkedIn For further inquiries please contact: Alloksys Life Sciences Ronald Oosting, PhD MBA, CSO of Alloksys Life Sceinces B.V. E-mail: [email protected] LifeSpring Life Sciences Communication, Amsterdam Léon Melens Tel: +31 6 538 16 427 E-mail: lmelens@lifespring.nl Logo - SOURCE Alloksys Life Sciences

The dynamics of acute kidney injury market is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, incremental healthcare spending across the world and the expected launch of the emerging therapies during the forecast period. LAS VEGAS, June 21, 2022 /PRNewswire/ -- DelveInsight's Acute Kidney Injury Market Insights report includes a comprehensive understanding of current treatment practices, Acute Kidney Injury emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM (the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), and Japan. Key Takeaways from the Acute Kidney Injury Market Report As per DelveInsight analysis, the Acute Kidney Injury market size in the 7MM was approximately USD 5.4 billion in 2020. As per DelveInsight analysis, the total Acute Kidney Injury incident cases in the 7MM were approximately 10.9 million in 2020. The United States contributed to the largest incident-patient share (mortality adjusted), acquiring ~ 34.09% of the 7MM in 2020 Rising incidence of AKI will provide a larger window of opportunity for new treatment and prevention options The pipeline of AKI is quite robust with diverse products strengthening targeting prophylaxis of AKI in several complications such as Sepsis and post-cardiac-surgery mainlyLeading acute kidney injury companies such as Cerenis Therapeutics, Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others are developing novel drug candidates to improve the Acute Kidney Injury treatment landscape. The Acute Kidney Injury therapies in the pipeline include bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa) , and others. The key driver for the surge in acute kidney injury market size is the rise in the number of incident cases of acute kidney injury. Discover more about therapies set to grab major acute kidney injury market share @ Acute Kidney Injury Market Landscape Acute Kidney Injury Overview Acute kidney injury (AKI), also known as acute renal failure (ARF), is a disorder that causes progressive azotemia with or without oliguria over a period of hours or days. Acute kidney injury is defined as a sudden loss of renal function, clinically expressed as an acute reversible surge in nitrogen waste products as measured by blood urea nitrogen and serum creatinine levels over hours to weeks. Acute kidney injury causes an abrupt loss in renal function, which results in waste product retention, electrolyte abnormalities, and changes in volume status. Acute kidney injury is classified into prerenal, postrenal, and intrinsic renal. Many people with acute kidney injury are asymptomatic, while others experience generalized non-specific acute kidney injury symptoms such as nausea, vomiting, weakness, dizziness, lower back pain, passing less urine than usual, unexplained loss of appetite, feeling sick or vomiting, shortness of breath, and swelling of the legs or other body parts. An increase in serum creatinine and a reduction in urine output are commonly used for acute kidney injury diagnosis. Acute Kidney Injury Epidemiology Segmentation As per DelveInsight, there were approx 10.9 million acute kidney injury incident cases in the 7MM in 2020. Among the EU5 countries, Germany had the highest acute kidney injury incident population in 2020. The Acute Kidney Injury market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into Total Incident Population of Acute Kidney Injury (AKI) in Hospitalized Patients Mortality Adjusted Incident Population of AKI in Hospitalized Patients Stage-specific Incident Population of AKI Age-specific Incident Population of AKI Download the report to understand which factors are driving acute kidney injury epidemiology trends @ Acute Kidney Injury Epidemiological Insights Acute Kidney Injury Treatment Market For the past several years; it has been observed that the current acute kidney injury treatment is primarily supportive in character, with no therapeutic approaches demonstrating benefit in treating the condition. Off-label acute kidney injury medications used to treat AKI include ACE inhibitors, angiotensin II-receptor blockers (ARBs), diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and renal replacement therapy (RRT). Monitoring urine output and, at first, serum creatinine levels (SCr) numerous times each day is a cornerstone of the therapy for all patients with acute kidney injury. It is also indicated to correct electrolyte imbalances, quit or adjust nephrotoxic medicines, and dose-adjust pharmaceuticals with renal elimination. To know more about Acute Kidney Injury treatment, visit @ Acute Kidney Injury Guidelines Acute Kidney Injury Pipeline Therapies and Key Companies bRESCAP: Alloksys ANG-3777 (BB3): Angion Biomedica/ Vifor Pharma EA-230: Exponential Biotherapies Ilofotase alfa: AM Pharma ASP1128: Astellas Pharma Ruconest (Conestat alfa): Pharming Technologies Learn more about the acute kidney injury medications @ Drugs for Acute Kidney Injury Acute Kidney Injury Market Dynamics Treatment-related adverse effects are quite rare, resulting in successful acute kidney injury treatment choices. Moreover, patients have easy access to reimbursements since their ailment necessitates long-term management, such as dialysis. In addition, several government activities are being undertaken by adopting various programs concerning acute kidney injury, which is expected to improve the global AKI prospect and thus bolster the actue kidney injury market. Furthermore, several biomarkers, including NGAL, Cystatin-C, and others, are being investigated for use in acute kidney injury diagnosis. The validation of these new biomarkers could provide new methods for detecting the start and severity of kidney injury. Future research in the acute kidney injury market is underway with the goal of better understanding of the underlying processes and, as a result, improve outcomes for AKI patients. Moreover, a robust pipeline with a novel mechanism of action and increasing incidence are major market drivers of the acute kidney injury market. Additionally, the acute kidney injury pipeline is also expected to change the current dynamics of the acute kidney injury market, which presently comprises biologics and molecules with new mechanisms of action like ANG-3777 (BB3), ASP1128, Ilofotase alfa, Ruconest (Conestat alfa), bRESCAP, EA230, and others. However, there are several barriers to the acute kidney injury market growth. One such factor is the lack of awareness. If the patients have cardiac issues, the situation becomes even more complex. Moreover, long-term health repercussions, as well as longer hospital stays and high health-care expenses, highlight AKI's enormous societal impact. In addition, several risk factors, such as diabetes and heart failure, have substantial implications for patients' quality of life, making it challenging to develop promising future interventions and thus hindering the acute kidney injury market growth. Scope of the Acute Kidney Injury Market Report Study Period: 2019–2032 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Acute Kidney Injury Companies: Cerenis Therapeutics Alloksys, Vifor Pharma, Exponential Biotherapies, Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, Nephraegis Therapeutics, Vasomune, Unicycive, LG Chem, Pharming Group, Angion Biomedica, Elysium Health, Sentien Biotechnologies, Pharmazz, Arch Biopartners, Guard Therapeutics, RegeneRx Biopharmaceuticals, Astellas Pharma, Amniotics, Mission Therapeutics, Bessor pharma, Kantum Pharma, ABIONYX, and others Key Acute Kidney Injury Therapies: bRESCAP, ANG-3777, EA-230, Ilofotase alfa, ASP1128, Ruconest (Conestat alfa), and others Therapeutic Assessment: Acute kidney injury current marketed and emerging therapies Acute Kidney Injury Market Dynamics: Acute kidney injury market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Acute Kidney Injury Market Access and Reimbursement Discover more about acute kidney injury drugs in development @ Acute Kidney Injury Clinical Trials Table of Contents Get in touch with our Business executive @ Healthcare Due Diligence Services Related Reports Acute Kidney Injury Pipeline Acute Kidney Injury Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key acute kidney injury companies including Atox Bio, AM Pharma Holding, Quark-Pharmaceuticals, LG Chem, Pharming Group, Angion Biomedica, among others. Acute Kidney Injury Epidemiology Forecast Acute Kidney Injury Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted acute kidney injury epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key chronic kidney disease companies, including Bayer, AstraZeneca, Celgene, Ipsen, among others. Anemia in Chronic Kidney Disease Pipeline Anemia in Chronic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in chronic kidney disease companies, including Pieris Pharmaceuticals, Jiangsu HengRui Medicine, Shenyang Sunshine Pharmaceutical, Biocad, among others. Diabetic Kidney Disease Pipeline Diabetic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key diabetic kidney disease companies, including Gilead Sciences, Kyowa Kirin, Bayer, among others. Polycystic Kidney Disease Pipeline Polycystic Kidney Disease Pipeline Insight, 2022 report provides comprehensive insights about 22+ companies and 22+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in polycystic kidney disease companies, including Abbott, Reata Pharmaceuticals, XORTX Therapeutics, Sanofi Genzyme, among others. Kidney Transplant Rejection Pipeline Kidney Transplant Rejection Pipeline Insight, 2022 report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the pipeline landscape. It covers the pipeline drug profiles, including clinical and non-clinical stage products. It also covers the key anemia in kidney transplant rejection companies, including Medeor Therapeutics, Talaris Therapeutics, CSL Behring, Novartis, among others. Other Trending Reports Pediatric Growth Hormone Deficiency Market | Non-Cystic Fibrosis Bronchiectasis Market | X-Linked Retinitis Pigmentosa Market | Otitis Media Market | Central Retinal Vein Occlusion Market | Frontotemporal Dementia Market | Follicular Lymphoma Market | Diabetes Market | Blastic Plasmacytoid Dendritic Cell Neoplasm Market | Bevacizumab Biosimilars Insight | Bacterial Conjunctivitis Market | FENEBRUTINIB Market | Peripherally Inserted Central Catheter Devices Market | Cardiac Biomarkers Testing Devices Market Related Healthcare Blogs Acute Kidney Injury Market Outlook Acute Kidney Injury Treatment Market IgA Nephropathy Market About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP