surface modification local drug delivery · and surgery service barry kupperman, md, phd •...
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![Page 1: SURFACE MODIFICATION LOCAL DRUG DELIVERY · and Surgery Service Barry Kupperman, MD, PhD • Professor; Chair, Department of Ophthalmology. UC, Irvine • Director, Gavin Herbert](https://reader033.vdocuments.us/reader033/viewer/2022042219/5ec595c45cee4454e935ea49/html5/thumbnails/1.jpg)
Interface Biologics, Inc.Spinning out Drug Delivery Technology
Sold Aug 2019 Spin out Q4 2019
SURFACE MODIFICATION LOCAL DRUG DELIVERY
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Epidel Technology: patented non-polymeric prodrugs for precise local drug delivery
2
Linker
Prodrug dissolution Prodrug degradation into linker and free drug
Biologically inactive molecule
Active API GRAS list moietyDevice coating or
implant
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Zero-Order Release Kinetics from Multiple Form Factors
MICROSPHERES
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riam
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ase
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Time in incubation medium (Days)
CYLINDERS
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COATINGS
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Time in incubation medium (Weeks)Confidential
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Effects of EnvironmentEffects of Formulation
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llets
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Time in 100% Serum (Bovine) at 37⁰C (Days)
⚫ Release from IBE-814
⚫ Release from IBE-1017
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IBE-
81
4 P
elle
ts (
%)
Time in Release Medium at 37⁰C (Days)
Release in 100% FBS
Release in 1% FBS in PBS
Release in PBS
Engineerable (controllable) drug release kinetics and duration
Effects of Form Factor
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Dex
amet
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e R
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ate
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Form Surface Area (mm2)
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Ripple Therapeutics Strategic Focus on Ophthalmology
with conditions that are treated with
and a need for
Validated MOAs
EngineerableDuration
Easy Route of Administration
with suboptimal response to current
therapies
Large Patient Populations
DME = Diabetic Macular Edema; RVO = Retinal Vein Occlusion; NIU = Non-Infectious Uveitis, AMD = Age Related Macular Degeneration
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IBE-814 Intravitreal (IVT) Implant is a dexamethasone prodrug cylinder delivered from a 30G needle
Competitive advantage over IVT steroid market leader
Potential for ↓ in steroid-related cataracts and IOP AEsNo polymer Carrier
Zero-order drug releaseFor 6 to 9 months
30G needle; direct delivery
Well Characterizeddegradation products
1/10th drug load of a commercial
Dexamethasone product
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✓ Rat POC PD Q2 2018
✓ Rabbit PK Q2 2018
✓ Rabbit PD Q3 2018
✓ FDA pre-IND Q4 2018
✓ CMC initiated Q1 2019
✓ Initiate Tox Studies Q3 2019
• Initiate Phase II Clinical Trial Q3 2020
• Interim readout Q4 2020
IBE-814 IVT Development Program Key Milestones
FDA confirmed abbreviated regulatory path visa 505(b)(2)
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IBE-814 IVT exhibits zero-order drug release and sustained inhibition of VEGF-induced vascular leakage
1.US 20130302324 A1
N o t T e s t e d
1 W E E K
Ne
ga
tiv
e
Co
ntr
ol
Co
mm
erc
ial
Imp
lan
tIB
E-8
14
Im
pla
nt
1 0 W E E K S 6 M O N T H S
70
µg
Dex
70
0 µ
g D
exSh
am In
ject
ion
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David Boyer, MD• President, Retina Vitreous
Associates Medical Group• Professor of Ophthalmology, USC
Keck School of Medicine
Jeffrey Heier, MD• Director, Ophthalmic
Consultants of Boston• Co-Director, Vitreoretinal
Fellowship,Tufts Medical School
Judy Gordon, DVM• President, ClinReg Consulting
Services• FDA & EMA approval for 1st
intraocular sustained-release drug delivery product
• Over 100 IDEs, INDs, 510(k)s, HUDs and HDEs approved
Ike Ahmed, MD• Director, Glaucoma and
Advanced Anterior Segment Surgery, University of Toronto.
• Clinical Professor Ophthalmology & Vision Science at the University of Utah.
Elias Riechel, MD• Professor of Ophthalmology,
Tufts University School of Medicine
• Director, Vitreoretinal Diseases and Surgery Service
Barry Kupperman, MD, PhD• Professor; Chair, Department of
Ophthalmology. UC, Irvine• Director, Gavin Herbert Eye
Institute
Experienced Team of Ophthalmology Experts guiding our Product Development
Xyzagen Inc.
Adrianna Manzi, PhD• Co-Founder Athlen Inc• CMC expert with 30 years of
experience in R&D of small/ large molecules and combination products
Christopher Crean, MSc• Founder & CEO, Xyzagen Inc • Prior experience includes
Founder 1st Order Pharmaceuticals & NA Head of Clinical Pharm/Nonclin Dev, Valeant
Jeff Edelman, PhD• Ocular Research Solutions• Former Allergan Nonclinical
Research Team Leader, Global Team Leader
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Low dose (n=18)
High dose (n=18)
Interim Analysis at 3 months supports:
• 1 mo CST
• 2 mo IOP -
• 3 mo BCVA
Low dose (n=7)
1A
High dose (n=7)
S TA G E BS TA G E A n=14 n=36
1B
2B
IBE-814 Phase II Clinical Trial: DME and RVO (50 patients total)
DME + RVO
Patients
AUSTRALIAN
Sites
Primary endpoint (BCVA) at 6 months; all patients followed to 18 months
2A
4 sites 12 sites
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TECHNICAL POC Pre -CLINICAL CLINIC
Ripple Therapeutics Pipeline
DISCOVERY
Op
hth
alm
olo
gy
IBE-814Intravitreal Implant
Posterior Inf lammation(DME, RVO, NIU)
IBE-1119Intravitreal Implant
Wet AMD
Post-CataractInf lammation
IBE-119Intracameral Implant
Glaucoma IBE-1020
Intracameral Implant
Dry AMDIBE-1212
Intravitreal Implant
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Raising $25M Series A round to
complete Phase II trial for IBE-814
IVT and continue development
of technology platform