Coronavirus – COVID-19 Program
The Company is actively reviewing current studies characterizing the outbreak of SARS-CoV-2 (COVID-19). These published reports clearly illustrate that acute kidney injury (AKI) and acute, multiple, organ injury are key factors in the most serious cases of COVID-19 hospitalization and death.
XORTX’s XRx-101 program (a novel formulation of uric acid lowering agent) could be an important therapy with the ability to decrease acute kidney, as well as health consequences associated with Coronavirus infection.
XORTX reported topline results in Nov 2020, that a majority of individuals hospitalized with coronavirus/ COVID-19 showed evidence of co-incidence of uric acid concentrations greater than normal and acute kidney injury. Severity of Acute kidney injury during coronavirus/COVID-19 infection has been associated with worse outcomes and increased mortality.
XRx-101 a Therapy Designed to Treat Coronavirus / COVID-19
XORTX has filed new intellectual property rights for XRx-101 as a treatment aimed at decreasing acute kidney disease and organ injury associated with viral infection.
SARS-CoV-2 (COVID-19) is a serious viral infection due to a coronavirus. Coronavirus infections such as SARS and MERS and specifically COVID-19 can be frequently accompanied by pneumonia, acute kidney injury, proteinuria and hematuria1,2. Acute kidney injury (“AKI”) has been identified as an independent risk factor for patients’ in-hospital mortality due to COVID-19 as well as other Coronavirus infections2. Early reports suggested a lower incidence (between 3% to 9%) of AKI in those with COVID-19 infection2,6,7. Recent reports, however, have shown a higher frequency of renal abnormalities. A study of 59 patients with COVID-19 found that 34% of patients developed massive albuminuria on the first day of admission and 63% developed proteinuria during their stay in hospital8. Equally concerning, individuals with “Long COVID-19” appear to have increased susceptibility to kidney damage and end-stage kidney disease.10
Based on these recent studies, the Company believes that its Oxypurinol formulation, XRx-101, has the potential to be a front-line treatment for severe cases of Coronavirus and that this therapy has the ability to decrease morbidity and mortality in hospitalized patients. Management’s belief that XRx-101 is a possible treatment for COVID-19 is based upon its reported potential to prevent acute uric acid induced injury. Historic studies from animal and human data that show that acute tissue injury can lead to rapid accumulation of uric acid and uric acid crystals that aggregate in kidneys and induce acute kidney injury3,4. When acute kidney injury accompanies pneumonia, post-discharge outcomes are worse than either diagnosis alone. Patients who survive a pneumonia hospitalization and develop acute kidney injury are at high risk for major adverse kidney events including death and should receive careful follow-up4. Perhaps more importantly, Oxypurinol has been previously studied for anti-viral properties9, a characteristic that may decrease morbidity and mortality of COVID-19.
A comprehensive clinical picture with regard to COVID-19 continues to be defined. Reported illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, recent reports suggest serious illness occurs in 10-14% of cases. Older people and people of all ages with severe chronic medical conditions — like heart disease, lung disease and diabetes, for example seem to be at higher risk of developing serious COVID-19 illness. Very concerning is the emergence of new variant of SARS-CoV-2 and their many fold increased transmissibility and increased rate of hospitalization.11
- Saraladevi Naicker, Chih-Wei Yang, Shang-Jyh Hwang, Bi-Cheng Liu, Jiang-Hua Chen, Vivekanand Jha, The Novel Coronavirus 2019 Epidemics and Kidneys, Kidney International March 2, 2020. https://www.kidney-international.org/article/S0085-2538(20)30251-9/pdf
- 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 deal of Covid-19 patients, medRxiv, March 04_2020 https://www.medrxiv.org/content/10.1101/2020.02.18.20023242v1
- Wilson FP., Tumor Lysis Syndrome, Adv Chronic Kidney Dis, 21(1)18, 2014 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4017246/
- Chawla LS., Amdur RL., Faselis C., Kimmel PL., Palant CE., Impact of Acute Kidney Injury in Patients Hospitalized with Pneumonia, Crit Care Med, 45(4)600-606, 2017 https://www.ncbi.nlm.nih.gov/pubmed/28291091
- Perez-Mazliah D et al, Allopurinol reduced antigen-specific and polyclonal activation of human T-cells, Frontiers in Immunology, Sept 2012
- Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA,2020,doi:10.1001/jama.2020.1585.
- Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of 2019 novel coronavirus infection in China. medRxiv preprint first posted online Feb. 9, 2020. https://doi.org/10.1101/2020.02.06.20020974Li Z,
- Wu M, Guo J, et al. Caution on Kidney Dysfunctions of 2019-nCoV Patients. medRxiv preprint doi: https://doi.org/10.1101/2020.02.08.20021212.
- El-Farrash, Youssef JM., and El-Mongy SE., Allopurinol as a potential therapeutic agent for recurrent herpes labialis, J Med Dent Sci, Jun 50(2):147-154
- Bowe B, et al. J Am Soc Nephrol. 2021;doi:10.1681/ASN.2021060734.
- Sheikh A et al_SARS-CoV-2 Delta - Doubles Hospitalization_ The Lancet_Sept 2021+PIIS0140673621013581