Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

开始日期2023-12-19

申办/合作机构

AM-Pharma BV

[+1]

NCT05890794 / Completed临床1/2期

Open-Label Pilot Trial to Evaluate the Effects of Ilofotase Alfa on Biomarkers in Adult Patients With Hypophosphatasia

The goal of this clinical trial is to compare the effectiveness of two doses of ilofotase alfa, an enzyme replacement treatment, in patients with hypophosphatasia (HPP). The main question it aims to answer is if the harmful accumulating levels of extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP) can be reduced with ilofotase alfa.
Researchers will compare the two doses of ilofotase alfa to see if treatment effects differ between the doses.

开始日期2023-05-15

申办/合作机构

AM-Pharma BV

NCT04411472 / Terminated临床3期

A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI

Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis.
The study has three distinct SA-AKI trial populations:
The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI.
In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients.
There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

开始日期2020-11-02

申办/合作机构

AM-Pharma Holding BV

100 项与 Ilofotase alfa 相关的临床结果

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100 项与 Ilofotase alfa 相关的转化医学

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100 项与 Ilofotase alfa 相关的专利（医药）

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项与 Ilofotase alfa 相关的文献（医药）

2024-02-19·Critical care (London, England)

Phenotype-specific therapeutic efficacy of ilofotase alfa in patients with sepsis-associated acute kidney injury.

Article

作者: Niklas Bruse ; Katerina Pardali ; Maarten Kraan ; Matthijs Kox ; Peter Pickkers ; REVIVAL investigators

BACKGROUND:

There is no effective treatment for sepsis-associated acute kidney injury (SA-AKI). Ilofotase alfa (human recombinant alkaline phosphatase) has been shown to exert reno-protective properties, although it remains unclear which patients might be most likely to benefit. We aimed to identify a clinical phenotype associated with ilofotase alfa's therapeutic efficacy.

METHODS:

Data from 570 out of 650 patients enrolled in the REVIVAL trial were used in a stepwise machine learning approach. First, clinical variables with increasing or decreasing risk ratios for ilofotase alfa treatment across quartiles for the main secondary endpoint, Major Adverse Kidney Events up to day 90 (MAKE90), were selected. Second, linear regression analysis was used to determine the therapeutic effect size. Finally, the top-15 variables were used in different clustering analyses with consensus assessment.

RESULTS:

The optimal clustering model comprised two phenotypes. Phenotype 1 displayed relatively lower disease severity scores, and less pronounced renal and pulmonary dysfunction. Phenotype 2 exhibited higher severity scores and creatinine, with lower eGFR and bicarbonate levels. Compared with placebo treatment, ilofotase alfa significantly reduced MAKE90 events for phenotype 2 patients (54% vs. 68%, p = 0.013), but not for phenotype 1 patients (49% vs. 46%, p = 0.54).

CONCLUSION:

We identified a clinical phenotype comprising severely ill patients with underlying kidney disease who benefitted most from ilofotase alfa treatment. This yields insight into the therapeutic potential of this novel treatment in more homogeneous patient groups and could guide patient selection in future trials, showing promise for personalized medicine in SA-AKI and other complex conditions.

2024-01-03·Intensive care medicine

Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).

Article

作者: Peter Pickkers ; Derek C Angus ; Kristie Bass ; Rinaldo Bellomo ; Erik van den Berg ; Juliane Bernholz ; Morten H Bestle ; Kent Doi ; Chistopher J Doig ; Ricard Ferrer ; Bruno Francois ; Henrik Gammelager ; Ulf Goettrup Pedersen ; Eric Hoste ; Susanne Iversen ; Michael Joannidis ; John A Kellum ; Kathleen Liu ; Melanie Meersch ; Ravindra Mehta ; Scott Millington ; Patrick T Murray ; Alistair Nichol ; Marlies Ostermann ; Ville Pettilä ; Christoffer Solling ; Matthias Winkel ; Paul J Young ; Alexander Zarbock ; REVIVAL investigators

PURPOSE:

Ilofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its efficacy and safety.

METHODS:

In this international double-blinded randomized-controlled trial, SA-AKI patients were enrolled < 72 h on vasopressor and < 24 h of AKI. The primary endpoint was 28-day all-cause mortality. The main secondary endpoint was MAKE90, other secondary endpoints were (i) days alive and free of organ support through day 28, (ii) days alive and out of the intensive care unit (ICU) through day 28, and (iii) time to death through day 90. Prior to unblinding, the statistical analysis plan was amended, including an updated MAKE90 definition.

RESULTS:

Six hundred fifty patients were treated and analyzed for safety; and 649 for efficacy data (ilofotase alfa n = 330; placebo n = 319). The observed mortality rates in the ilofotase alfa and placebo groups were 27.9% and 27.9% at 28 days, and 33.9% and 34.8% at 90 days. The trial was stopped for futility on the primary endpoint. The observed proportion of patients with MAKE90A and MAKE90B were 56.7% and 37.4% in the ilofotase alfa group vs. 64.6% and 42.8% in the placebo group. Median [interquartile range (IQR)] days alive and free of organ support were 17 [0-24] and 14 [0-24], number of days alive and discharged from the ICU through day 28 were 15 [0-22] and 10 [0-22] in the ilofotase alfa and placebo groups, respectively. Adverse events were reported in 67.9% and 75% patients in the ilofotase and placebo group.

CONCLUSION:

Among critically ill patients with SA-AKI, ilofotase alfa did not improve day 28 survival. There may, however, be reduced MAKE90 events. No safety concerns were identified.

2023-04-03·BMJ open

Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury.

Article

作者: Peter Pickkers ; Derek C Angus ; Jacques Arend ; Rinaldo Bellomo ; Erik van den Berg ; Juliane Bernholz ; Morten Bestle ; Kristine Broglio ; Jan Carlsen ; Christopher J Doig ; Ricard Ferrer ; Michael Joannidis ; Bruno Francois ; Kent Doi ; John A Kellum ; Pierre-François Laterre ; Kathleen Liu ; Ravindra L Mehta ; Patrick T Murray ; Marlies Ostermann ; Ville Pettilä ; Sharon Richards ; Paul Young ; Alexander Zarbock ; Anne Louise Kjølbye

INTRODUCTION:

Sepsis, the leading cause of acute kidney injury (AKI), is associated with a high morbidity and mortality. Alkaline phosphatase (ALP) is an endogenous detoxifying enzyme. A recombinant human ALP compound, ilofotase alfa, showed no safety or tolerability concerns in a phase 2 trial. Renal function improvement over 28 days was significantly greater in the ilofotase alfa group. Moreover, a significant relative reduction in 28-day all-cause mortality of >40% was observed. A follow-up trial has been designed to confirm these findings.

METHODS AND ANALYSIS:

This is a phase 3, global, multi-centre, randomised, double-blind, placebo-controlled, sequential design trial in which patients are randomly assigned to either placebo or 1.6 mg/kg ilofotase alfa. Randomisation is stratified by baseline modified Sequential Organ Failure Assessment (mSOFA) score and trial site. The primary objective is to confirm the survival benefit with ilofotase alfa by demonstrating a reduction in 28-day all-cause mortality in patients with sepsis-associated AKI requiring vasopressors. A maximum of 1400 patients will be enrolled at ∼120 sites in Europe, North America, Japan, Australia and New Zealand. Up to four interim analyses will take place. Based on predefined decision rules, the trial may be stopped early for futility or for effectiveness. In addition, patients with COVID-19 disease and patients with 'moderate to severe' chronic kidney disease are analysed as 2 separate cohorts of 100 patients each. An independent Data Monitoring Committee evaluates safety data at prespecified intervals throughout the trial.

ETHICS AND DISSEMINATION:

The trial is approved by relevant institutional review boards/independent ethics committees and is conducted in accordance with the ethical principles of the Declaration of Helsinki, guidelines of Good Clinical Practice, Code of Federal Regulations and all other applicable regulations. Results of this study will determine the potential of ilofotase alfa to reduce mortality in critically ill patients with sepsis-associated AKI and will be published in a peer-reviewed scientific journal.

TRIAL REGISTRATION NUMBER:

EudraCT CT Number 2019-0046265-24. US IND Number 117 605 Pre-results.

CLINICALTRIALS:

gov number: NCT04411472.

项与 Ilofotase alfa 相关的新闻（医药）

2024-01-16

·BioSpace

AM-Pharma Initiates Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

Trial will evaluate ilofotase alfa as a treatment to prevent renal damage in at-risk patients following open heart surgery Ilofotase alfa’s clinical record of renal protective effects supports therapeutic potential in underserved and high-need indication UTRECHT, The Netherlands--(BUSINESS WIRE)-- AM-Pharma B.V. today announced that the first patients have been treated in a Phase 2 clinical study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as a preventive treatment for cardiac surgery-associated renal damage (CSA-RD). With over 2 million open heart surgeries1 performed worldwide every year, CSA-RD represents a critical surgical complication for which there is no specific pharmacological therapy. CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery. CSA-AKI occurs in approximately 1 out of 3 patients undergoing open heart surgery and is the predominant risk factor for death post-surgery, with 2-5% of patients requiring renal replacement therapy as a result. Ilofotase alfa has a proven safety and tolerability pro a strong record of renal protective effects as observed in previous clinical studies. Notably, prior Phase 2 and Phase 3 trials with ilofotase alfa demonstrated significant improvements in Major Adverse Kidney Events by day 90 (MAKE90) in sepsis-associated AKI. As recently reported in a publication2 on the REVIVAL Phase 3 trial, MAKE90 events were reduced to 57.2% of patients in the ilofotase alfa group compared to 64.7% in the placebo group. “Previous clinical trials showed ilofotase alfa had significant reno-protective effects in sepsis-associated AKI patients. Given the role of AKI in long-term renal impairment in cardiac surgery patients, ilofotase alfa preventative treatment could have substantial clinical benefits on renal function and potentially save lives,” said Peter Pickkers, MD, PhD, Principal Investigator in the Phase 2 study and Professor of Experimental Intensive Care Medicine at Radboud University Nijmegen Medical Centre, The Netherlands. The multicenter, double-blind, randomized, placebo-controlled Phase 2 trial will evaluate the efficacy and safety of ilofotase alfa as a preventive treatment in 150 patients scheduled for cardiac surgery and at risk for CSA-RD. Treatment will be administered intravenously before and after surgery, with a follow-up period of 60 days. The primary endpoint will be the ratio between pre- and post-surgery creatinine levels. Important exploratory endpoints will be the incidence of Major Adverse Kidney Events (MAKE) and the incidence and severity of AKI post-surgery. The trial is planned to end in Q4 2024 with a data readout expected in early 2025. Ilofotase alfa was recently evaluated in a Phase 1b pilot study as enzyme replacement therapy in hypophosphatasia (HPP) patients. “With the initiation of the Phase 2 trial in CSA-RD following the positive results from the Phase 1b study in HPP we have achieved important progress toward establishing ilofotase alfa’s potential through our updated clinical development strategy. We are confident in our new trajectory and remain committed to delivering a therapeutic solution for patients in these two severe, high-need conditions,” said Juliane Bernholz, PhD, Chief Executive Officer of AM-Pharma. “The clinical centers we are working with show great enthusiasm for our approach with ilofotase alfa and we look forward to the data readout.” About ilofotase alfa Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that has been shown to be stable and highly active in multiple clinical trials. 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. In hypophosphatasia, ilofotase alfa addresses elevated levels of pyridoxal-5′-phosphate (PLP), inorganic pyrophosphates (PPi), two disease-related biomarkers that are related to bone mineralization and pain sensation, for example. About cardiac surgery-associated renal damage (CSA-RD) CSA-RD is a clinical complication that arises from acute kidney injury (AKI) following open heart surgery performed with the use of a cardiopulmonary bypass (CPB) pump. Apart from sepsis, this type of surgery is the most frequent cause of AKI. CSA-AKI occurs in about 1 in 3 patients undergoing this surgical procedure.3 Pre-operative and intra-operative measures can be taken to reduce the risk of AKI, and post-operative management strategies may also help mitigate further damage.4 However, there is currently no pharmacological therapy to prevent AKI, and the kidney injury can result in long-term renal impairment and the need for renal replacement therapy (RRT) such as dialysis. Notably, mortality can be up to 50% in CSA-AKI patients who require RRT post-operatively. About AM-Pharma AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is being developed for the treatment of patients with acute kidney injury (AKI) and has been granted FDA fast-track status. We also develop ilofotase alfa in the severe rare disease hypophosphatasia where ilofotase alfa has orphan drug status in the US and EU. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety pro 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: . 1 2 Pickkers P et al., Intensive Care Med., 2024 3 Andújar A et al., Front. Nephrol., 2023 4 Ostermann M et al., J Clin Med., 2021 View source version on businesswire.com: Contacts Investors: Juliane Bernholz, Chief Executive Officer j.bernholz@am-pharma.com Media: Trophic Communications Gretchen Schweitzer or Priscillia Perrin +31 6 52 33 15 79 am-pharma@trophic.eu Source: AM-Pharma View this news release online at:

临床2期快速通道孤儿药临床1期

2023-10-11

·BioSpace

AM-Pharma Announces Positive Clinical Data From Phase 1b Study Evaluating Ilofotase Alfa in Hypophosphatasia Patients

Ilofotase alfa demonstrates pharmacologically relevant effect on disease specific biomarkers and a positive safety pro adult patients with hypophosphatasia; Data to be presented by Lothar Seefried, MD, at the American Society for Bone and Mineral Research’s Symposium on Rare Bone Diseases on Thursday, October 12, 2023 UTRECHT, The Netherlands--(BUSINESS WIRE)-- AM-Pharma B.V. today announced positive clinical results from the Phase 1b study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as potential enzyme replacement therapy in adult hypophosphatasia (HPP) patients. HPP is an inherited metabolic disease, characterized by low activity of tissue non-specific alkaline phosphatase (TNAP), caused by mutations at the ALPL gene. This low activity leads to accumulation of inorganic pyrophosphate (PPi), a strong inhibitor of mineralization, as well as pyridoxal-5’-phosphate (PLP), an important cofactor for enzymes. The disease can range widely in severity, however most adults with HPP suffer from recurrent fractures, muscle weakness, joint diseases and pain.1 In the open-label pilot trial, a total of 12 patients were randomly assigned to one of two treatment arms and received a single intravenous dose of either 0.8 mg/kg or 3.2 mg/kg. Patients were followed for 10 days after dosing to evaluate changes in the biochemical fingerprint of HPP, safety and tolerability. The primary objectives for the study were changes in serum levels of PLP and PPi as compared to baseline. For PLP, the maximum proportional reduction was 35% in the 0.8 mg/kg cohort and 66% in the 3.2 mg/kg cohort. The mean time to return to 90% of baseline was 55 hours in the low-dose cohort and 168 hours in the high-dose cohort. The maximal proportional reduction for PPi was 36% in the 0.8 mg/kg cohort and 77% in the 3.2 mg/kg cohort. The mean time to return to 90% of baseline was 9.3 hours in the low-dose cohort and 53 hours in the high-dose cohort. In addition, ilofotase alfa was well-tolerated with pharmacokinetics consistent with observations from previous clinical studies. “The pronounced effect on all HPP disease relevant biomarkers together with a positive safety and tolerability profile, consistent with previous clinical studies with ilofotase alfa, supports its further development as a treatment option for adult HPP patients who are currently underserved,” said Juliane Bernholz, PhD, Chief Executive Officer of AM-Pharma. The full dataset will be presented at the American Society for Bone and Mineral Research – Rare Bone Disease Alliance (ASBMR-RBDA) Symposium at the Vancouver Convention Centre in Vancouver, BC, Canada. The presentation by Lothar Seefried, MD, from the University of Wuerzburg, lead investigator of the trial, is scheduled for 3:00 pm PDT on Thursday, October 12, 2023, in session III: Latest in Clinical Trials. "Considering the wide range of clinical manifestations of HPP, there's an unequivocal need to expand therapeutic opportunities for these patients," added Lothar Seefried, MD. "The encouraging early results confirming dose-dependent reductions of PLP and PPi levels upon treatment with ilofotase alfa underline the compound's therapeutic potential in that indication and I'm looking forward to evaluating ilofotase alfa in next stage clinical studies." About ilofotase alfa Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase, that has been shown to be stable and highly active in multiple clinical trials. 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. In hypophosphatasia, ilofotase alfa addresses elevated levels of pyridoxal-5′-phosphate (PLP), inorganic pyrophosphates (PPi), two disease related biomarkers that are related to, for example, bone mineralization and pain sensation. About hypophosphatasia HPP is a rare inherited disease characterized by a deficiency in alkaline phosphatase which is essential for bone mineralization and general functions. HPP patients of all ages can exhibit a wide variety of symptoms that worsen overtime, including bone injury, severe muscle pain and weakness. The disease can also lead to life-threatening complications in infants. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) granted AM-Pharma Orphan Drug Designation (ODD) for ilofotase alfa in HPP. In preclinical models, ilofotase alfa was able to achieve improved overall survival of severe disease, as well as restoration of phenotypes associated with HPP. About AM-Pharma AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is being developed for the treatment of patients with acute kidney injury and has been granted FDA fast-track status. We also develop ilofotase alfa in the severe rare disease hypophosphatasia where ilofotase alfa has orphan drug status in the US and EU. With approximately 1,000 subjects evaluated to date in clinical trials, ilofotase alfa has a proven safety pro 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: . 1 Tournis, S., Yavropoulou, M. P., Polyzos, S. A., & Doulgeraki, A. (2021). Hypophosphatasia. Journal of Clinical Medicine, 10(23), 5676. View source version on businesswire.com: Contacts Investors: Juliane Bernholz, Chief Executive Officer j.bernholz@am-pharma.com Media: Trophic Communications Eva Mulder or Priscillia Perrin +31 6 52 33 15 79 am-pharma@trophic.eu Source: AM-Pharma View this news release online at:

临床结果快速通道孤儿药临床1期

2023-09-26

·FierceBiotech

AM-Pharma cuts staff, says goodbye to CEO as lead kidney injury asset redirected

AM-Pharma boasts some major Big Pharma investors, including Pfizer, Takeda and AbbVie. After failing in a phase 3 study for a severe kidney complication of sepsis, AM-Pharma is redirecting its lead program to a different kind of kidney damage. Along with the revised clinical development strategy, the Dutch biotech is cutting staff and getting a new CEO. A phase 3 trial for ilofotase alfa in sepsis-associated acute kidney injury (SA-AKI) was halted for futility in October 2022 after failing to improve the rate of all-cause deaths at 28 days. SA-AKI is a complex and severe complication of sepsis when the body’s infection-fighting mechanism turns on itself. The condition has a high rate of death and is associated with poor outcomes. Despite failing the study, AM-Pharma noted a reduction in major adverse kidney events by day 90, with an investigator saying “the renal benefit observed in this study in ilofotase alfa-treated patients cannot be ignored.” This potential benefit was revealed in a pre-specified secondary analysis of all 649 patients. AM-Pharma has decided to heed the warning, but it’s going to take some growing pains to get there. The company announced Tuesday an unspecified workforce reduction but declined in an email to specify the number of people affected. The company’s LinkedIn page lists 33 employees. Long-time CEO Erik van den Berg will also pass the reins to Juliane Bernholz, Ph.D., who had been serving as chief operating officer. Van den Berg had held the top role since 2011 and will now join the company’s supervisory board and remain a strategic advisor. Ilofotase alfa will proceed in two indications, with cardiac surgery-associated renal damage serving as the lead indication. A phase 2 study will test the therapy in 150 patients who are at risk of developing renal damage based on pre-operative kidney function and scheduled for a complex open-heart surgery. A separate phase 1b study is already underway to use ilofotase alfa as an enzyme replacement therapy for patients with the rare bone metabolism disorder hypophosphatasia. Initial clinical results are expected before the end of the year. AM-Pharma boasts some major Big Pharma investors, including Pfizer, Takeda and AbbVie. Others include Nestle, Cowen Healthcare Investments and Forbion. Pfizer put down $87.5 million in 2015 to take a minority interest in the Utrecht, Netherlands-based company but also snagged an option to buy it outright for $512.5 million if interested once phase 2 results for ilofotase alfa were ready. The New York Big Pharma walked away after getting a look at the data in 2018. The revised clinical development plan is supported by existing investors who have supplied additional funding, although AM-Pharma did not provide details.

临床2期并购临床3期高管变更

100 项与 Ilofotase alfa 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
急性肾损伤	临床3期	美国更多	AM-Pharma Holding BV 更多
低碱性磷酸酶血症	临床2期	德国更多	AM-Pharma BV 更多
溃疡性结肠炎	临床前	荷兰更多	AM-Pharma Holding BV 更多
脓毒症所致急性肾损伤	终止	荷兰更多	AM-Pharma Holding BV 更多
脓毒性休克	终止	荷兰更多	AM-Pharma Holding BV 更多

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04411472 (REVIVAL, Pubmed)	临床3期	脓毒症所致急性肾损伤	-	Ilofotase alfa	(憲憲廠廠鏇蓋繭壓齋蓋) = 積鏇淵夢廠淵齋鬱鬱鑰範選鹹築夢網鹽窪築製 (顧鏇夢鹽遞鹹簾鏇鑰鹹 ) 更多	不佳	2024-01-01
				Placebo	(憲憲廠廠鏇蓋繭壓齋蓋) = 簾選艱糧遞繭構構窪願範選鹹築夢網鹽窪築製 (顧鏇夢鹽遞鹹簾鏇鑰鹹 ) 更多
NCT04411472 (REVIVAL, Corporate Publications) 人工标引	临床3期	脓毒症所致急性肾损伤	649	ilofotase alfa	-	不佳	2022-10-20
				Placebo