Valeritas — Technical Presentation (September 2019)
10 slides from Valeritas's technical presentation, Sep 13, 2019
Slide 1: Continuous SubQ Infusion of CBD via the h-Patch
Continuous SubQ Infusion of CBD via the h-Patch™ ©2019 Valeritas, Inc.
Slide 2: Oral CBD Achilles' Heel
Oral CBD Achilles’ Heel • Inconsistent Dosing as a result of: • Very poor overall bioavailability • High intra- and inter-subject pharmacokinetic variability • Large food effect • Significantly reduced half life versus IV/SQ admin • And… long term safety concerns remain: • Generation of toxic liver
Slide 3: We Can Do Better… Much Better
We Can Do Better… Much Better Clues to improving CBD delivery are in the literature: Take away: While CBD is still metabolized by the liver with IV dosing, the dramatic effect of the 1st pass effect is essentially eliminated… but IV dosing is not ideal. ©2019 Valeritas, Inc. 3
Slide 4: Enter the h-Patch
Enter the h-Patch™… • Simple, all-in-one subcutaneous drug delivery • Fully disposable with no exposed needle • No programing • No infusion set • Comfortable floating needle • Easy to use • Convenient • Discreet ©2019 Valeritas, Inc. 4
Slide 5: How Does the h-Patch Work?
How Does the h-Patch™ Work? Hydraulically regulated patch drug delivery system • The h-Patch™ provides a precise fixed continuous basal delivery rate without the pulsatile delivery seen in electronic systems • Provides basal & bolus delivery opportunities • Delivers payload over 24h period ©2019 Val
Slide 6: h-Patch Highlights
h-Patch™ Highlights • All mechanical, fully disposable infusion pump • Precise fixed continuous basal delivery without the pulsatile delivery seen in electronic systems • SubQ infusion delivery via a needle, no catheter or cannula • Basal and bolus delivery options • “Floating needle” and foam backe
Slide 7: Pharmacokinetic Study Design
Pharmacokinetic Study Design • Two dosing groups of h-Patch™ delivered pure CBD isolate solution (100mg/ml): A. Basal delivery only (40mg) B. Basal plus full bolus volume (76mg) • A 48h study performed in dogs • Delivery of CBD occurs over the first 24h • Plasma collected at regular intervals over 4
Slide 8: h-Patch delivery of 40mg CBD isolate
h-Patch™ delivery of 40mg CBD isolate Delivery of CBD ©2019 Valeritas, Inc. 8
Slide 9: CBD SubQ Infusion Highlights
CBD SubQ Infusion Highlights • SubQ infusion with the h-Patch™ provides measurable plasma levels of CBD with a single 24h infusion • CBD levels in blood detected within an hour of the beginning of infusion • CBD still detectable 24h after completion of h-Patch™ infusion We find peak plasma levels on
Slide 10: Interested in Learning More?
Interested in Learning More? Reach out to learn more about our CBD preclinical data and to discuss potential partnerships to advance the Science of CBD therapeutics: Erick J. Lucera, CFO Joseph Saldanha, CBO Valeritas, Inc. Valeritas, Inc. [email protected] [email protected] Jess Barnes, P
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