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Non Confidential
A Leader Redefining How Kidney Disease is Treated
Investor Presentation – March 2021
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Forward Looking Statements
This document contains forward-looking information pursuant to applicable securities law. All information thataddresses activities or developments that XORTX expects to occur in the future are forward-looking statements.Forward-looking statements are based on the estimates and opinions of management on the date the statements aremade. However, they should not be regarded as a representation that any of the plans or objectives will be achievedas actual results may differ materially from those expressed or implied by the forward-looking information set forthin this document due to risks and uncertainties affecting XORTX, including access to capital, the successfulcompletion of clinical trials and receipt of all regulatory approvals. The forward-looking statements in this documentare based on a number of assumptions which may prove to be incorrect, including assumptions concerning generalbusiness and economic conditions, positive clinical trials and the availability of financing. XORTX assumes noresponsibility to update forward-looking statements in this document.
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Key Highlights
XORTX clinical development stage products target xanthine oxidase and uric acid lowering, which has been shown to have an important clinical effect. Significant unmet global market opportunities.
Focused on developing clinical stage assets to treat kidney disease
Three lead products in development with strong IP and established proof of concept.XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD) - Orphan MarketXRx-101 for Coronavirus infection/ COVID-19XRx-221 for type 2 Diabetic Nephropathy ( T2DN) – Large Market
Three Proprietary Products –ALL ARE FIRST-IN-CLASS
U.S. Phase 2 study of Uric Acid Lowering in type 2 Diabetic Nephropathy Patients; Topline Phase 2a data readout - August 2019 – Xanthine oxidase inhibition decreases proteinuria!
Positive Phase 2a clinical data readout for T2DN and Uric Acid
Expected initiation of a pivotal registration study in Polycystic Kidney Disease within 12 months - potentially under an SPAExpected initiation of a phase 2/3 study in Coronavirus/COVID-19 within 12 Months
Orphan drug opportunity in polycystic kidney disease.
Q2 2021 $ upfront Licensing + revenue split in COVID (Aspreva / Roche model)Q3 2021 Initiate Phase 3 – COVID-19Q3 2021 $ ADPKD – CO-Development Licensing arrangement Q4 2021 $ Initiate Phase 3 ADPKD registrational trial
2021 Key Catalysts
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Development Timeline:** Planning to Initiate Pivotal Study under SPA in second half of 2021 **
Mfg GMP(9 months)
Finalize IND
Finalize ODD
BA Study
Protocol/SPAPh III
Ph3 Pivotal Study under SPA - (30 months)
NDA filing
(Accelerated Review)
MarketingApproval
2020 2021 2022 2023 2024 2025
GMP - Good Manufacturing Process StandardsIND - Investigational New Drug ODD - Orphan Drug DesignationBA - Bio-availability Study in ManSPA - Special Protocol AssessmentNDA - New Drug Application for marketing
XRx-008 – Autosomal Dominant Polycystic Kidney Disease (ADPKD)
4Potential licensing opportunities after ODD!
Global Pharma
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Development Timeline:** Depending on FDA Feedback Compassionate Use or Initiate Pivotal Study Q3 of 2021 **
Mfg GMP(7 months)
Finalize IND
BA Study
Design Ph III
Ph3 Pivotal Study(8 months)
NDA filing
Clincal/Comrcl GMP SupplyMarketingApproval
2020 2021 2022 2023 2024 2025
GMP - Good Manufacturing Process StandardsIND - Investigational New Drug ODD - Orphan Drug DesignationBA - Bio-availability Study in ManSPA - Special Protocol AssessmentNDA - New Drug Application for marketing
XRx-101 – A Coronavirus / Acute Kidney Injury Therapy
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PharmaCo-Dev
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Endothelial NO
Depletion
Oxidative Stress
Activation Renin
Angiotensin System
Systemic Inflammation
High Blood Pressure
Vascular Damage
Fibrosis
Kidney Inflammation
Proteinuria
Decline of Filtering Capacity
Normalized Blood Pressure
Decreased Proteinuria
Decrease and Reversal of Decline in Filtering Capacity
Momeni A, Effect of Allopurinol on Decreasing Proteinuria in Type 2 Diabetic Patients, Int J Kid Dis, 4(128), 2010
Goicoechea et al. (2010) Effect of allopurinol in CKD progression and CV risk. Clin J Am Soc Nephrol 5:1388-1393
Soletsky B et. al., Uric Acid Reduction Rectifies Prehypertension in Obese Adolescents, Hypertension 2012;60:1148-1156
Xanthine Oxidase and Uric Acid (UA): Injury Kidney Disease
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High UA Levels Predict Cardio-Vascular-Renal Injury
Lowering UA Protects Kidney Health in Human Clinical Trials
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Decreasing Uric Acid levels in Diabetes Patients may delay progression to ESRD and the need for dialysis or transplant
ESRD – A Life Altering Event• 4 hours per day on dialysis• Loss of ability to work full time • Dependence on family• Pain and declining health are constant burden• Shortened survival – only 50% of patients survive
two years
• In progressive kidney disease uric acid hastens loss of filtering capacity of kidneys
• A therapy that maintains and extends kidney health can redefine kidney disease treatment in the future
Source: Curr Opin Nephrol Hypertens – 22(2): 185-192, 2013
XORTX Therapies are designed to delay or reverse progressionof kidney disease, to prevent ESRD
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Patent Claims Term
US 9,155,740 Method of use claims covering uric acid lowering agents (Xanthine Oxidase Inhibitors) in the treatment of “Diabetic Nephropathy” Acid
2025 ** estimated GATT extension of 4 - 5 years
PCT/US14/30292 Formulations patent covering Xanthine Oxidase Inhibitors: specifically for Oxypurinol (XRx-008)
European Patent allowed US pending2034
Provisional Patent A novel formulation for treatment of co-morbidity and mortality associate with coronavirus infection(XRx-101)
2040
Provisional Patent Compositions and Methods of Enhancing Anti-viral Therapies
2041
Note: Orphan exclusivity adds to product protection in Autosomal Dominant PolycysticKidney Disease (ADPKD)
Strong Patent Protection – Covering all Uric Acid Lowering Agents Use in Progressive Kidney Disease
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XRx-008: A Novel Formulation of Oxypurinol
• XRx-008 - a proprietary formulation of Oxypurinol with 3X increased bioavailability – wholly owned by XORTX and developed “In-house”
• Increased oral dosing range• Increased tolerability increases compliance and supports chronic dosing• Independent Phase 2 clinical trials show Oxypurinol lowers uric acid, improves
vascular function
• XRx-008 - pre-IND* submission to FDA meeting completed, Orphan Drug Designation (ODD) application initiated
• Negotiating Phase 3 Registration Trial with FDA and Company also intends to seek Special Protocol Assessment
• Orphan Drug Classification: ~150,000 U.S. patients
XRx-008 in Polycystic Kidney Disease (PKD)
9* IND - Investigational New Drug application
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(Han M, et al., Hyperuricemia and Deterioration of Renal function in ADPKD, BMC Nephrol 15:63-2014)
(n=32)
-9
-7
-5
-3
-1
1
3
5
7
e-G
FR c
hang
e (m
l/m
in/1
.73m
^2)
Time (yrs)
eGFR (ml/min/1.73m^2/yr)
PreTx (-1yr) Post Tx (1yr)
-5
-4
-3
-2
-1
0
1
2
Chan
ge in
Ser
um U
ric
Acid
(mg/
dL)
Time (yrs)
Serum Uric Acid ( mg/dL)
PreTx (-1yr) Post Tx (1yr)
p=0.001 p=0.001
Serum uric acid (SUA) concentrations are higher in APDKD patients than controls. (Mejias et al. Hyperuricemia, gout, and autosomal dominant polycystic kidney disease. Am J Med Sci 1989; 297: 145–148)
Higher SUA is associated with increased kidney volumes, increased End Stage Renal Disease (ESRD), and ADPKD disease progression. (Helal, 2013)
Increased SUA is strongly associated with endothelial dysfunction (ED) via decreased nitric oxide bioavailability. (Khosla, 2005, Zoccali 2006, Kurowska 2002, Portaluppi2004)
In early stage ADPKD patients, uric acid levels (p
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Development Timeline:** Planning to Initiate Pivotal Study under SPA in second half of 2020 **
Mfg GMP(9 months)
Finalize IND
Finalize ODD
BA Study
Protocol/SPAPh III
Ph3 Pivotal Study under SPA - (30 months)
NDA filing
(Accelerated Review)
MarketingApproval
2020 2021 2022 2023 2024 2025
GMP - Good Manufacturing Process StandardsIND - Investigational New Drug ODD - Orphan Drug DesignationBA - Bio-availability Study in ManSPA - Special Protocol AssessmentNDA - New Drug Application for marketing
XRx-008 – Autosomal Dominant Polycystic Kidney Disease (ADPKD)
11Potential licensing opportunities after ODD!
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XRx-101 – A Novel Formulation of Oxypurinolfor the treatment of COVID-19 / Coronavirus
• XRx-101 - a proprietary formulation of xanthine oxidase inhibitor, inhibit oxygen radical and uric acid production, ameliorate kidney injury associated with COVID-19 infection.
• Current evidence suggests beneficial anti-viral effects Akaike et al, 1990; El-Farrash et al, 2003
• Xanthine oxidase inhibition suppressed influenza symptoms and increases survival in mouse model. Akaike et al, 1990
• Viral infection due to influenza increases xanthine oxidase activity 400 fold in the mouse. Akaike et al, 1990
• Xanthine oxidase expression is increased in adult respiratory syndrome (SARS). Grum et al 1987
• Coronavirus infections are often associated with increased IL-6, TNF-a and NF KappaB expression and inflammatory injury. Liu B et al, 2020; DeDiego ML et al, 2014 & Dosch SF et al, 2009
• Xanthine oxidase inhibition can decreases IL-6, TNF-a and block NF Kappa B signaling. 12
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Coronavirus – COVID-19 – Progression & High Uric Acid
Lung
Endothelium Injury
RISK FACTORS:High Blood Pressure, pre-Diabetes, Diabetes,Chronic/Polycystic kidney disease
== Endothelial Dysfunction Pre-existing Vascular Injury
Kidney Injury
COVID-19 Infection is VascularInfection/ HypoxiaLytic Virus
Cell debris –DAMP’s DNA
Xanthine oxidase
Uric Acid >60% with AKI in Hospital
UA Inflammation Pro Coagulation
Hypercatabolic State/ PRO-COAGULATION
Cardiac/ NeurologicalInjury
Serious 2’ Health Consequences –Stroke, Heart Attack, Liver, GI, Major blood vessel clotting, Pancreatitis ….
DEATH
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Acute kidney Injury occurs early during infection and is associated with hyperuricemia. AKI is persistant.
Proposed Clinical Trial
Chan et al, AKI in Hospitalized Patients with COVID-19, JASN, Sept 2020
“Unpublished” - Preliminary study results @ Mount Sinai, NY:
Hospitalized individuals with AKI – 63% had very high uric acid levels.
N>1100 individuals, where greater than 60% of individuals with acute kidney injury had elevated uric acid levels above the normal range
Expected Healthy hyperuricemia rate? - ~20% > 6 mg/dL
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COVID-19 Viral Infection & Acute Kidney Injury (AKI)New York – 1/2
Preliminary Data:“MAKE” – Major Adverse Kidney Events
Hospitalized individuals in New York
Uric acid normal range:3-6 mg/dL
Hyperuricemia is associated with MAKE (dialysis or death).
Hyperuricemia occurs early in COVID-19 infection.
AKI occurs early in COVID-19 infection.
Hyperuricemia increases the risk for AKI and so death.
Hyperuricemic
Crystalluria
Normal
Metabolic Acidosis
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The World Health Organization investigative team that visited China in February, led by Canadian expert Dr. Bruce Aylward, reported last week that it places the R0 of COVID-19 at between 2 and 2.5 – a number it considers “relatively high.”*
• The R0 for COVID-19 is a median of 5.7, according to a study published online in Emerging Infectious Diseases. That’s about double an earlier R0 estimate of 2.2 to 2.7
• The median R value for seasonal influenza was 1.28 (IQR: 1.19–1.37).
• While the impact of flu varies, it places a substantial burden on the health of people in the United States each year. CDC estimates that influenza has resulted in between 9 million – 45 million illnesses, between 140,000 –810,000 hospitalizations and between 12,000 – 61,000 deaths annually since 2010.
Conclusion: Compared to Influenza (140,000 – 810,000 hospitalization/year R0=1.4 to 2.8) it is projected that COVID19 will have a 2X rate of hospitalizations with 280,000 – 1,020,600 hospitalizations/year in the future.
(*) Source (*): WHO COVID Reporthttps://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
COVID Infection is producing a substantial, emerging, AKI market
https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdfhttps://wwwnc.cdc.gov/eid/article/26/7/20-0282_articlehttps://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
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XRx-101 for Coronavirus Induced Acute Kidney Disease
XRx-101 in Coronavirus InfectionSuppression of Viral and Acute Kidney Injury
Opportunity #1a: Orphan Disease – Phase 3
Compassionate use or,Registration Study Initiation 2020
Data Readout 2021
U.S. Marketing Approval TBD
~ Hospitalized Individuals4,000,000 U.S.
~50,000,000 Individuals Worldwide
A Crisis Driven – Significant Market Opportunity
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U.S. Revenue estimate: ? Equivalent to the increased dialysis cost?
Assuming 1.6 M hospitalized over next 24 months, projected 30 day course of treatment
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Development Timeline:** Depending on FDA Feedback Compassionate Use or Initiate Pivotal Study Q4 of 2020 **
Mfg GMP(7 months)
Finalize IND
BA Study
Design Ph III
Ph3 Pivotal Study(8 months)
NDA filing
Clincal/Comrcl GMP SupplyMarketingApproval
2020 2021 2022 2023 2024 2025
GMP - Good Manufacturing Process StandardsIND - Investigational New Drug ODD - Orphan Drug DesignationBA - Bio-availability Study in ManSPA - Special Protocol AssessmentNDA - New Drug Application for marketing
XRx-101 – A Coronavirus / Acute Kidney Injury Therapy
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PharmaCo-Dev
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Progressive Kidney Disease
XRx-221 in Type 2 Diabetic Nephropathy
XRx-008 in Autosomal Dominant Polycystic Kidney Disease (ADPDK)
Opportunity #1:Orphan Disease – Phase 3
Opportunity #2:Diabetic Kidney Disease – Phase 2
Phase 2a Topline August 2019
Phase 2b Initiation 2022
Phase 3a ToplinePhase 3b Topline
August 2025 August 2026
U.S. Market Approval 2028
Two Significant Market Opportunities
Registration Study Initiation 2021
Data Readout 2023
U.S. Marketing Approval 2024
~ 150,000 Individuals U.S.
~1,500,000 Individuals Worldwide
~ 10,000,000 Individuals U.S.
~100,000,000 Individuals Worldwide
Estimated Peak Sales – USA $1.8B/yearWorldwide $4B/year
Estimated Peak Sales – USA $2.4B/yearWorldwide $5B/year 19
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Capital Structure
Market Capitalization ~$26 million
Common Shares Outstanding 109,976,717
Warrants 25,170,626
Options 5,600,000
Fully-diluted Shares Outstanding 140,747,343
Public Listings
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Key Takeaways
Scarce Assets Addressing a Large Market Opportunity
Strong Intellectual Property Portfolio
Initial Data Strongly Positions the Company For Clinical Success
Important Interim Data Readouts
Experienced Management Team With Significant Expertise in Drug Development
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Non Confidential
Contact Information: Dr. Allen [email protected] or 1-403-455-7727
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Non Confidential
INVESTOR PRESENTATION
Appendix
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Dr. Allen W. Davidoff, Ph.D.
James Fairbairn, CPA, ICD.D
Dr. Alan Moore, Ph.D.
Brian Mangal Dr. David Sans,FAARM, Ph.D.,
M.B.A.CEO
• 15 years drug development experience focused on clinical and regulatory program development as senior management in pharmaceutical R&D (two IND applications, two phase 1 studies, seven phase 2 studies, and one NDA
• Former Chief Scientific Officer, VP Product Development/ co-founder of Stem Cell Therapeutics Corp. (now Trillium TRIL: NASDAQ and TSX) and Senior Scientist and Head of Pharmacology, Cardiome Pharma Corp.
CFO
• 20+ years in senior finance roles with emerging companies. He is a Chartered Professional Accountant, having obtained his CPA designation in 1987 and is an Institute-certified Director. James Fairbairn holds a Bachelor of Arts from the University of Western Ontario. He is a director of several junior listed companies.
Senior Clinical and Regulatory Consultant
• Extensive clinical development experience and 23 years of senior management experience in pharmaceutical R&D. During his esteemed career, he has completed 11 investigational new drug (“IND”) applications or supplemental IND’s, 15 phase 1 studies, 12 phase 2 studies, 7 phase 3 studies and two new drug applications. Most recently CEO of BetaStem Inc.
Director, Business Development
• 15 years of clinical development experience
• Former Director of Biostatistics for Cardiome Pharma Corp, LedBiotmetrix of Cardiome’s clinical programs.
• Design, analysis and reporting on over 50 clinical trials, three FDA submissions, one TPD submission, a successful EMEA submission and worked on the successful NDA for Linezolid for Pharmacia/Pfizer and numerous successful trials with Celecoxib.
Director, Corporate Development
• 15+ years experience in corporate development gained through management and executive positions at Novartis, Pfizer, ImClone, and Summer Street Research Partners in Boston.
• Board Certified in Regenerative Medicine from the American Board of Regenerative Medicine (ABRM).
• Master's Degree in Chemical Engineering as well as a Ph.D. in Life Sciences and a MBA in Business Law.
Management Team
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Board of Directors
W. Bruce Rowlands – Chairman, Audit Committee Member • Biotechnology and investment banking background • Former Senior VP, Lorus Therapeutics, a leading Canadian biotechnology company and VP and Director, Dominick and
Dominick Securities Canada • Former Chairman and CEO, Eurocontrol Technics Group Inc., a TSX Venture Exchange listed companyAllen W. Davidoff, Ph.D. - Co-founder, CEO Ian Klassen – Director, Audit Committee Member • 20+ years experience in business management, public relations, government affairs and public company governance• Former Chief of Staff to the Canadian Speaker of the House of Common and current President and CEO of two gold
exploration companies listed on the TSX Venture ExchangePaul van Damme – Director, Audit Committee Chair • Extensive career in industry and finance including senior positions with a number of Canadian and US public companies • Biotech industry focus through experience with GlycoDesign, Allelix Pharmaceuticals Inc. including participating in the
sale of Allelix to NPS Pharmaceuticals, Inc. • Currently Managing Director, WCM CapitalAllan Williams – Director • 30+ years capital market (raised over $250 million in project capital), public company and mergers and acquisitions Mr. Anthony Giovinazzo – Board Advisor• Internationally recognized expert in intellectual property defense drug development and commercialization• Co-inventor, CEO and Director of Cynapsus Therapeutics, a Nasdaq-listed specialty company that developed the first
successful sublingual apomorphine thin film strip for Parkinson’s disease known as Kynmobi, approved by the US FDA on May 21, 2020 and Health Canada on June 15, 2020.
• Co-author of several peer reviewed papers and author of several papers on strategic and financing issues in the biopharmaceutical industry.
• Canadian finalist in Life Sciences for the E&Y Entrepreneur of the Year in 2014 and 2017 Recipient of the Finance Monthly, Game Changers Award and chosen as the inaugural recipient of the Bloom Burton Award, as the best of the best in Canadian Life Sciences as judged by a panel of US experts.
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Advisory Board
Dr. Petter Bjornstad, MD - Neprhologist• Clinical Researcher and Assistant Professor of Pediatrics and Medicine, University of Colorado School of Medicine • NIH and NDRF funded translational research with a track record of research potential and success • Authored over 70 peer reviewed manuscripts and several high impact journals• Principal investigator of several ongoing studies related to kidney disease and diabetes
Dr. Richard J. Johnson Jr., MD - Nephrologist• Tomas Berl Professor, Division of Renal Diseases and Hypertension, University of Colorado School of Medicine,
Anschutz Medical Campus
Dr. Anjay Rastogi – MD, PhD - Nephrologist• Anjay Rastogi, MD PhD is Professor and Clinical Chief of Nephrology at the David Geffen School of Medicine at UCLA,
Los Angeles, California. Dr. Rastogi is board certified in Nephrology and has a doctoral degree (PhD) in Pharmacology. He is heavily involved in research and serves as the Director of Nephrology Clinical Research Program, Medical Director of the ESRD | Dialysis Program, and Living Kidney Donor Program. Dr. Rastogi’s research interests include, Adult PKD, Fabry's Disease, Alport Syndrome and Diabetic Kidney Disease.
Dr. Federico Maese, MD • Cardiologist and Clinical Researcher focused on preventative cardiology and prevention of coronary artery disease • Extensive clinical experience in the management of diabetic patients with insulin resistance, metabolic syndrome and
extensive inflammation
Dr. Henk E. D. J. ter Keurs, MD, Ph.D. • Cardiologist, LIBIN Cardiovascular Institute of Alberta
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Effect of Xanthine Oxidase Inhibition in Influenza in Mice
Purpose: Evaluate biochemical parameters of influenza virus lung infection
Model: sBALF – influenza virus infected mice
Biochemical Characteristics:
After infection, mice showed 170x increase in adensinedeaminase (ADA) and 400 fold increase in Xanthine Oxidase (XO) activity per volume of alveolar lavage fluid
Results: • XO activity peaked at day six of infection. • ADA metabolites were increased: inosine, hypoxanthine,
xanthine and uric acid in serum. • Uric acid treatment improved survival rate of influenza virus
infected mice.
Conclusion: Increased nucleotide turnover in influenza virus and oxygen radical generation is a pathogenic principle in influenza virus infection.
Akaike T et al_Dependence on oxygen radical generation by XO of Pathogenesis of Influenza Virus Infection in Mice_ J Clin invest_ Volume 85_ March 1990_739
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Figure 4: Catabolic profile of adenosine in s-BALF. On day 2 on day 8 uric acid increases substantially.
Figure 6: Therapeutic effect of allopurinol on influenza virus-infected mice. Allopurinol was administered orally every 24 h at 1 mg/ mouse ( ) (n=11) or 2 mg per mouse ( ) (n=11), from days 4-7. Vehicle ( PBS) alone was given in the same manner to the control group ( ) ( n=14).
Ctrl
1mg(p=0.04)
2mg(p=0.01)
Effect of Xanthine Oxidase Inhibition in Influenza in Mice
Uric acid increases substantially as influenza infection progresses. Xanthine oxidase inhibition, greatly increases survival during influenza infection.
Xanthine oxidase inhibition representsa potentially important therapy
Akaike T et al_Dependence on oxygen radical generation by XO of Pathogenesis of Influenza Virus Infection in Mice_ J Clin invest_ Volume 85_ March 1990_739 28
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CLASS IP ADVANTAGES LIMITATIONS
Uricosurics Varied Decrease uric acid absorption/ reuptake Inappropriate: Increase kidney stone formation
Uricase Off Patent Acute IV use Cannot be used chronically
Xanthine Oxidase Inhibitors
Allopurinol Off Patent Decreases UA production and serum uric acid ~2-3 mg/dL.Well CharacterizedAcceptable side effect profile
Only approved for GOUTOnly works well in ~28% of individualsModest effect (~2-3 mg/dL)Side effects: Rash, Liver Enzymes, Kidney
Febuxostat 2019 Higher Potency - decreases UA production and serum uric acid ~2-6 mg/dL
Only approved for GOUT and Cancer * Recent FDA Boxed Warning
Oxypurinol(free acid)
2034 Decreases UA production ~2-3 mg/dLImproved tolerability
Modest effectPoor Bioavailability
XRx-008 2034 Decreases UA production ~2-3 mg/dLImproved tolerability3X increase in Bioavailability
Comparable efficacy to Allopurinol
XRx-101 2040 Inhibits Xanthine Oxidase, decreases uric acid productionClean safety profile and improved tolerability
None observed to date
Current Agents are Ineffective at Best
Competitive Landscape Analysis -Well Differentiated Compared to Landscape
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