The Acute Kidney Injury Therapies in the pipeline anticipated to launch in the next decade shall spur the AKI Market growth forward.
Acute Kidney Injury (AKI) is defined as a sudden advent of kidney failure or damage due to the accumulation of waste products in the bloodstream resulting in the improper fluid outflow. It is profoundly evident in elderly patients who are hospitalized, especially in intensive care units. The reported incident cases range from 22% to as high as 67% of admissions. The indication is widely associated with an array of organs that get affected, such as coronary heart disease, chronic kidney disease, diabetes, etc. It emerges as an ailment in about 5–30% of patients who undergo cardiothoracic surgery, liable on the definition used for AKI. If AKI appears after major abdominal surgery, the risk of death is markedly increased (over 12-fold). Besides, it is worthy to note that AKI occurs due to several clinical manifestations as well, such as sepsis, cardiac catheterization and cardiac surgery, which are mostly hospital-acquired.
The significant unmet need that encompasses AKI is that currently, neither there are any proven therapeutic strategies to reduce post-AKI sequelae, nor affirmed robust evidence till date to inform strategy for the provision of health care. Moreover, the Acute kidney injury market does not hold any approved therapy to treat it specifically, which also adds to its shortcomings.
The current AKI market is mainly dependent on the use of renal replacement therapies, and supportive therapies (such as antibiotics, maintenance of adequate nutrition, mechanical ventilation, glycemic control, anemia management etc.). The key advantage of AKI research and development is that it has a robust pipeline, which provides a lucrative opportunity to major key players such as Alloksys, Angion Biomedica, Quark Pharmaceuticals, AM-Pharma, Atox Bio, Exponential Biotherapies, MediBeacon, Astellas Pharma, and Pharming Technologies.
These prominent key players are efficiently involved in developing promising therapeutic interventions to treat the disease and associated manifestations in variable stages of clinical development.
A prominent key player Angion Biomedica is developing its significant therapy ANG-3777 for patients to reduce the severity of delayed graft function in Phase III stage of clinical development and AKI following cardiac surgical procedures involving cardiopulmonary bypass (CPB) in Phase II. A few months ago, in November 2019, an interim positive result was published by the company extrapolating positive long-term data from Phase II clinical trial of ANG-3777 in kidney transplant patients with AKI associated with delayed graft function at the American Society of Nephrology Kidney Week 2019. The promising finding included improved short- and long-term graft function for a period of 12‑month estimated glomerular filtration rate (eGFR), with no sign of increased adverse events as compared with the control arm patients. These positive outcomes can substantiate its entry in the AKI market soon in the coming years, proving to be a boon for the therapeutic landscape. Recently in April 2020, Angion announced that ANG-3777 met the primary endpoint, which included the estimation of time to produce >1,200 ccs of urine over 24 h. The findings were in link with the interim data published in November 2019; however, the trial’s primary completion date is March 2021. Followed by these positive findings, the company is expected to report data from an ongoing Phase III study of ANG-3777 in the second half of 2020.
Teprasiran (QPI-1002),in development by Quark Pharmaceuticals,is another late-stage asset for patients at high risk for AKI following cardiac surgery. The company is employed in developing novel RNAi-based therapeutics, wherein Teprasiran is a nuclease-resistant, synthetic double-stranded RNA oligonucleotide intended to temporarily inhibit the expression of the pro-apoptotic gene p53, via activation of the RNA interference (RNAi) pathway. The Phase II findings of the drug have met the primary endpoint—it significantly reduced the incidence, severity and duration of AKI within the first five days of surgery in high-risk patients—followed by other multiple secondary endpoints as well.
With the same positive upfront, AM-Pharma raised 133 million USD dollars,in July 2019,to carry out a global pivotal Phase III trial of recombinant human alkaline phosphatase (recAP) in 1,400 patients with sepsis-associated AKI. This trial is based on positive results from its STOP-AKI Phase II clinical trial, which established significant improvements in survival and kidney function. The company is all set to launch its Phase III trial in October 2020 to study the effect of recAP on 28-day mortality in patients admitted to the ICU with AKI that is caused by sepsis.
Astellas Pharma is developing its therapeutic candidate, i.e., ASP1128, in the mid-stage of clinical development. The US FDA has awarded the drug with Fast Track Designation for patients at increased risk of developing moderate-to-severe AKI post-coronary artery bypass and/or valve (CABG/V) surgery. Although the clinical data for the drug has not been published yet, the company has high hopes for its candidate in AKI treatment paradigm.
Furthermore, Ruconest (Conestat alfa), which is a recombinant human C1 esterase inhibitor; rhC1INH, developed by Pharming Technology, completed its mid-stage of clinical development in July 2018 in patients with contrast-induced nephropathy in high-risk patients by using Pharming’s technology platform. An update of PROTECT Trial was given by the company in April 2020, wherein, administration of rhC1INH before coronary angiography attenuated renal injury as reflected by urinary neutrophil gelatinase-associated lipocalin and cystatin C. Moreover, the safety profile of rhC1INH was also encouraging in a patient population with multiple comorbidities.
The key emerging therapies in the Acute Kidney Injury pipeline will substantially provide a better outlook for the AKI treatment market to prosper and ultimately focus on addressing all the unmet needs surrounding the condition; the increasing AKI prevalence is expected to furnish a broader scope for the indication to get addressed. In addition, in terms of futuristic approaches, the chief objectives should inculcate treatment of associated comorbidities, reduction of further escalation of kidney damage, and treatment of associated complications.
Overall, the Acute kidney injury market holds a wide perspective for the investigators as well as health care practitioners to thrive in the long run.