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Non-Resistant Antimicrobial Therapy: Treating Superbugs That Cause Nosocomial Pneumonia

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Non-Resistant Antimicrobial Therapy: Treating Superbugs That Cause Nosocomial Pneumonia

  1. 1. Non-Resistant Antimicrobial Therapy: Treating Superbugs That Cause Nosocomial Pneumonia August 28, 2020
  2. 2. What is the problem? Hospital Acquired Pneumonia “HAP/VAP is the biggest problem among already sick patients, it has the highest medical complexity.” -Daniel Hoft, MD, PhD • 375,000 HAP cases/year in the U.S. • High mortality rate (30% - 50%) due to o co-morbidity o Antibiotic treatment failures due to antibiotic resistance • MDR Gram-negative bacteria – o increasing despite antibiotic stewardship programs o Few antibiotic treatment options • Current treatments • 14-25+ days long • economic burden on patients, hospitals, and insurers.
  3. 3. In vitro data: • Half-life (t1/2) SynAmp: 1.5 hrs • CYP2B6 IC50: 7 µM • Hepatocyte EC50: 2 µM • ADMET & Safety data How does product/service solve problem? A New First-Line HAP Treatment A non-resistant intravenous combination antibiotic prescribed as first line treatment for HAP/VAP patients, dosed once daily. Bacteria bacteria bacteria bacteria + SynAmp + antibiotic + SynAmp + antibiotic 64x potency No resistance Bioavailability over 30 days Enhancement
  4. 4. How does product/service solve problem? Platform Technology • Penetrates bacterial membrane, disrupts ion balance. • Disrupts resistance mechanisms in bacteria and allows more antibiotics to penetrate the bacteria. • Works with various antibiotics and against various microbes. E. Coli SynAmp in membrane
  5. 5. What is the market use? Current Product Price HAP/VAP Patients Addressable Market in US $2500-$5500 375,000 $935 Million - $2.1 Billion Initial Indication: HAP/VAP • Interviewed payers showed willingness to cover higher prices: $5,000 - $12,000 • First Year Launch: $5,000 x 37,000 patients = $185M • SynAmp has a potential for other parallel indications, including: chronic Urinary Tract Infections ($2B market)
  6. 6. What competition exists? Antibiotics for HAP Class Non- resistance Nightmare Pathogens Cost Cefepime, Meropenem (Current treatments) 𝛃-lactams Zerbaxa, Avycaz (approved) 𝛃-lactam drugs + 𝛃-lactamase InhibitorsMK-7655A (Investigational) SYNAMP New Class of adjuvants
  7. 7. What is the status of the intellectual property? • US 10,463,044 (issued 2019) – A method of reversing the resistance of a multi-drug resistant bacterium….by three different classes of molecules o One additional patent application allowed (US 2017-0347652); one application pending (US 2019-0201379); and one currently being drafted • License of patent rights to be acquired by Upaya Pharmaceuticals from UMSL.
  8. 8. Regulatory Strategies • Single vial package: SynAmp + antibiotic. • HAP is an unmet need • Expedited pathways: Fast-track approval & priority review.
  9. 9. Development Stage • Recently funded by NIH via MU MBArC bootcamp program with 100% match from University - $200,000 for non-GLP pre-clinical studies (de-risk) *Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT)
  10. 10. Upaya Pharmaceuticals Team Members George W. Gokel, PhD Principal Investigator > 40 years of experience in academia, industry and pharmaceuticals expert witness Mohit B. Patel, PhD Biological Studies Experienced in biological studies, life- science entrepreneurship, product development Saeedeh Negin, PhD Chemical Synthesis & Analysis Experienced in academia and industry in chemical synthesis, manufacturing and analysis Advisers Bruce Hamper, PhD Medicinal Chemist Bill Simon, MBA CEO, Traxxsson Ron Dolle, PhD Director, Center for Drug Discovery Team Michael Kinch, PhD WashU, Center for Research Innovation
  11. 11. Summary • Unmet need: Resistant HAP/VAP • Product: A first of its kind non-resistant antibiotic • Intellectual property: Platform technology: 1 issued + additional pending & draft applications • Competitive Advantages: New class and non-resistance • Market: Primary indication launch $200 million, multiple indications • Regulatory: Expedited pathways (3-4 years, 300 patients) • Team: Experienced and motivated pre-clinical team • Seeking: Funding, development partner, experienced team members (executive and drug developers)

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