The application includes discussion of the clinical development plan and requests for guidance regarding the novel proprietary formulation of Oxypurinol specifically designed to treat individuals at risk of AKI associated with COVID-19 coronavirus infection.
This application with the
- COVID-19 is frequently accompanied by pneumonia, acute kidney injury, proteinuria, and hematuria1,2 which can lead to multiple organ failure and death.
- Though early reports suggested a low incidence (between 3% to 9%) of AKI in those with COVID-19 infection2,3,4, data from the
U.S. indicates that 25-35% of patients hospitalized with COVID-19 develop AKI.5-7 - Up to 20% of those need renal replacement therapy (RRT), and the mortality rate in patients that experience AKI in the setting of COVID-19 is several-fold higher than patients without AKI.6
- AKI has been identified as an independent risk factor for patients’ in-hospital mortality due to COVID-192.
- In a study of hospitalized patients with AKI, a hypercatabolic phenotype in a significant proportion of patients with AKI, manifested by extremely high serum uric acid levels8.
“This submission is an important step for the Company and the XRx-101 program and we move forward with a strong belief, verified by human data, that XRx-101 (Oxypurinol) may be an effective treatment for acute kidney injury that accompanies coronavirus (COVID-19),” stated Dr.
Currently, the US has accounted for nearly 6 million COVID-19 infections, with an estimated 330,000 hospitalizations, close to 180,000 deaths, 65,000 individuals that are now permanently on dialysis, and nearly 44% (~80,000) of those released from hospital have ongoing acute kidney injury. In the absence of a viable vaccine, during the next 12 months these numbers could grow two to three-fold, and could give rise to a kidney disease crisis with substantial future socio-economic cost. A therapy to decrease the risk of acute kidney injury due to COVID-19 infection would address the rapidly growing medical need.
The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 coronavirus at this time.
About XRX-101 (Oxypurinol)
References:
- Naicker, S., Yang, C.-W., Hwang, S.-J., Liu, B.-C., Chen, J.-H. & Jha, V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 97, 824–828 (2020).
- Cheng, Y., Luo, R., Wang, K., Zhang, M., Wang, Z., Dong, L., Li, J., Yao, Y., Ge, S. & Xu,
G. Kidney impairment is associated with in-hospital death of COVID-19 patients. medRxiv 2020.02.18.20023242 - Wang, D., Hu, B., Hu, C., Zhu, F., Liu, X., Zhang, J., Wang, B., Xiang, H., Cheng, Z., Xiong, Y., Zhao, Y., Li, Y., Wang, X. & Peng, Z. Clinical Characteristics of 138 Hospitalized Patients with 2019 Novel Coronavirus-Infected Pneumonia in
Wuhan , China. JAMA - J. Am. Med. Assoc. 323, 1061–1069 (2020). - Guan, W., Ni, Z., Hu, Y., Liang, W., Ou, C., He, J., Liu, L., Shan, H., Lei, C., Hui, D. S., Du, B., Li, L., Zeng, G., Yuen, K.-Y., Chen, R., Tang, C., Wang, T., Chen, P., Xiang, J., et al. Clinical characteristics of 2019 novel coronavirus infection in China. N. Engl. J. Med. 2
- Hirsch JS, Ng JH, Ross DW, et al. Acute Kidney Injury in Patients Hospitalized with Covid-19. Kidney Int. 2020.
- Chan L, Chaudhary K, Saha A, et al. Acute Kidney Injury in Hospitalized Patients with COVID-19. medRxiv. 2020:2020.2005.2004.20090944.
- Mohamed MM, Lukitsch I, Torres-Ortiz AE, et al. Acute Kidney Injury Associated with Coronavirus Disease 2019 in
Urban New Orleans . Kidney360. 2020:10.34067/KID.0002652020. - http://www.xortx.com/2020/08/04/xortx-partners-with-mount-sinais-icahn-school-of-medicine-on-us-based-clinical-trial-in-covid-19/
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This news release includes forward looking statements that are subject to assumptions, risks and uncertainties. Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate. The Company cautions readers that all forward looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements. Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements. Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements. The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise.
Source:
2020 GlobeNewswire, Inc., source