surface modification local drug delivery · and surgery service barry kupperman, md, phd •...
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Interface Biologics, Inc.Spinning out Drug Delivery Technology
Sold Aug 2019 Spin out Q4 2019
SURFACE MODIFICATION LOCAL DRUG DELIVERY
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
Zero-Order Release Kinetics from Multiple Form Factors
MICROSPHERES
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CYLINDERS
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COATINGS
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Effects of EnvironmentEffects of Formulation
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⚫ Release from IBE-814
⚫ Release from IBE-1017
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IBE-
81
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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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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
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
✓ 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)
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
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erc
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tIB
E-8
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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
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
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
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
Raising $25M Series A round to
complete Phase II trial for IBE-814
IVT and continue development
of technology platform