This document discusses digital therapeutics (DTx), which are software-based interventions designed to treat medical conditions. DTx can be used alone or in combination with pharmaceuticals to improve clinical outcomes by empowering patients. The document outlines how DTx are developed through clinical trials and regulated like drugs. It also examines partnerships between DTx and pharmaceutical companies, noting both threats, such as DTx replacing drugs, and opportunities, such as improving outcomes and personalizing therapy.

1. Digital Therapeutics
Poison or Tonic for Pharma Industry?
daVinci Digital Therapeutics Srl
via Giovanni Durando 38/a - 20158 Milano – Italy
www.davincidtx.com
tel +39 02 2399 2985;
info@davincidtx.com; PEC: davincidigital@legalmail.it
Codice Fiscale e Numero di Iscrizione Registro delle Imprese di Milano Lodi Monza: 10664440962
Partita IVA: 10664440962
5.11.2019

2. Vision
Digital Therapeutics, alone or in combination, are
the first treatment option offered by the physician
to patients with chronic illness or dependence

3. Agenda
1. Digital Health and Digital Medicine
2. Digital Therapy
3. Digital Therapy and Pharmaceuticals

4. Digital Transformation… Next : Health

5. The Journey to 2025 – Driving Forces …
Patient
Impatient
Empowered
Chronic
Diseases
Digital
Revolution
Personalized
Medicine
Cancer
Aging





6. The Journey to 2025 – Driving Forces …
Patient
Impatient
Empowered
Chronic
Diseases
Digital
Revolution
Personalized
Medicine
Cancer
Aging




• Take control of their health
• Empowerement
• De-centralization
• Home Testing

7. The Journey to 2025 – Driving Forces …
Patient
Impatient
Empowered
Chronic
Diseases
Digital
Revolution
Personalized
Medicine
Cancer
Aging





8. The biggest challenge to health…
Drugs are not enough!
• Support
• Education
• Monitoring
• Adherence
Chronic Diseases!

9. • misura
• intervento
Digital Health
use of Digital Technologies to
(1) support and deliver
healthcare (2) improve health
and well-being of people
SMART HEALTH
Digital Health TechnologiesDigital Health Technologies

10. • measure
• intervention
Digital Medicine Digital Health
Technologies
based on
Digital Medicine TechnologiesDigital Medicine Technologies

11. Digital Therapy
DTx
Digital Health
Technologies
based on
Digital Therapy TechnologiesDigital Therapy Technologies
INTERVENE

12. Agenda
1. Digital Health and Digital Medicine
2. Digital Therapy
3. Digital Therapy and Pharmaceuticals

13. • therapeutic interventions
• Active Ingredient is an Algorythm
• developed through RCTs
• approved by regulatory bodies
• subject to HTA assessment
• reimbursed by NHS / insurance
• prescribed by a Physician
What are Digital Therapeutics?
• designed to modify the
behaviour of patients
• to improve clinical
outcomes

14. • therapeutic interventions
• Active Ingredient is an Algorythm
• developed through RCTs
• approved by regulatory bodies
• subject to HTA assessment
• reimbursed by NHS / insurance
• prescribed by a Physician
What are Digital Therapeutics?
• designed to modify the
behaviour of patients
• to improve clinical
outcomes

15. What are Digital Therapeutics not?
Therapy
Prescription OTC
Digital Health Technologies - Intervene
Patient Support - PSP
Physician Decision Support

16. Present, Future, Futuristic?
Marketed
a. Deprexis (EU 2009)
b. Reset (FDA 2017)
c. Reset-O (FDA 2017)
d. Zemy (EU 2018)
e. Oleena (FDA 2019)
Late Development
a. AKL-T01 (FDA expected 2019)
b. Somryst (FDA expected 2020?)
c. CureApp Smoking Cessation (2020?)
Early Development
a. Depression daVinci Digital Therapeutics
b. Obesity daVinci Digital Therapeutics

17. Algorithms must take the «form» of …
mApps, Games, Sensors….

18. DTx Mode of Action
1
8
Combination with a drug
• Monitoring of adherence to therapy
• Drug Dosage Recommendations
• Recommendations on AE management
- Diabetes (Voluntis w Roche, Sanofi)
- Oncology (Voluntis w AZ, Roche)
- Asthma / COPD (Propeller w GSK, Novartis, Chiesi;
Teva; Adherium w AZ)
-
Standalone
• Cognitive Behavioural Therapies – CBTs
• Other therapeutic options
- Dependencies (Pear Therapeutics)
- Depression (daVinci Digital Therapeutics)
- ADHD (Akili Interactive)
- Schizophrenia (Pear Therapeutics)
- Obesity (daVinci Digital Therapeutics)
DTx must improves clinical outcomes by involving and empowering
patients in the management of their diseases and therapies
DTx must improves clinical outcomes by involving and empowering
patients in the management of their diseases and therapies

19. What qualifies software as therapy?

20. DTx Discovery and Development
Therapeutic Intervention
delivered
1. «Active Ingredient»
3. Dashboard - Physician 2. «Excipients»
Patient-facing
Smartphone Application
Clinician-facing
Web Interface
4. Delivery Platform

21. DTx Discovery – Software Development


Standards
«Excipients»
«Active Ingredient»

22. DTx Pilot Clinical Development
1. Clinical Test - Usability and Acceptability
50 volunteers with / without the disease
2. Pilot Clinical Study to Assess Efficacy and Safety
 PoC Study
 50 patients, with milf to moderate depression
 Open, not controlled
 Endpoint : Patient Health Questionnaire-9 (PHQ-9) at day 30 (vs basal)

23. DTx Full Clinical Development
Randomized Clinical Trial
1. Development of a DTx combination with a specific drug (SD) :
DTx + SD > SD
2. Development of DTx standalone, to be added on Therapy As
Usual (TAU):
DTx + TAU > Digital Placebo + TAU

24. Who pays DTx?

25. •A-ccess
•E-ngagement
Why can DTx be disruptive?
A +++
E +++
A +
E +++
A +++
E -

26. Agenda
1. Digital Health and Digital Medicine
2. Digital Therapy
3. Digital Therapy and Pharmaceuticals

28. Pharma – DTx Partnerships
￭ Pear Therapeutics & Novartis [Various]*
￭ Click Therapeutics & Sanofi [Various]
￭ Click Therapeutics & Otsuka [Depres]
￭ Akili & Shionogi [ADHD]
￭ Gaia & Servier [Depression]
￭ Voluntis & Sanofi [Diabetes]
￭ Voluntis & Roche [Cancer]
￭ Voluntis & AstraZeneca [Cancer]
￭ Voluntis & Abbvie [Various]
￭ Novo Nordisk & Noom [Obesity]
￭ Bayer & Wellthy Therapeutics
* Terminated Oct 2019

29. Threats
• Drug Replacement
• Relationship with patient
• Real World / Real Time Data
• “The threat for today’s pharma is that
there are new players like us who own
the patient relationship and who cut
pharma out of the whole picture
• Pharma is like hardware suppliers; they
might supply our patients with
medication but in the end, the patients
use our app to track medications.
• Maybe we’ll end up telling them they
are taking the wrong medication.”

30. Opportunities
• To improve patient’s outcomes
• To increase drug value (Combo)
• To prolong drug life cycle (Combo)
• To personalize drug therapy
• New business areas (Standalone)
• Access to Real Time/Real World data
• To differentiate the company

31. @daVinciDTx daVinci Digital Therapeutics
www.davincidtx.com