emerging approaches to combination therapies in amd & dme - allegro ophthalmics
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Luminate® for the Treatment of Retinal Diseases
Ophthalmology Innovation SummitAugust 8, 2016
Vicken Karageozian, MDPresident
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
Luminate® - What does Allegro Offer?First in class anti-integrin product (Luminate®) with
novel MOA for anti-angiogenesis and vitreolysis
Late stage development with multiple programs in phase 2b or later DME phase 2b DEL MAR (mono, combo, treat and maintain therapy)
data lock Q1 2017 PVD phase 2b PACIFIC data lock Q1 2017 VMT phase 3 ready
~ 400 human subjects treated with well-tolerated safety
Non-clinical aspects of program de-riskedComposition of matter IP, solid PK, Tox, and CMC packages
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved2
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved3
Anti-Angiogenesis
Benefits
Increased durability Better safetyNew MOA with new treatment options
Benefits
Vitreolysis and PVD inductionBetter safetyNew MOA with new treatment options
DME Wet AMD PVD
Vitreolysis
VMT
Human Clinical Studies in Progress:
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved4
US Phase IIb DME (DEL MAR) Study
Stage 1 – 6 months, 148 subjects completed enrollment 3 monthly loading injections Efficacy endpoints mean change in BCVA and OCT
CRT at Weeks 16 & 20 1.0, 2.0, and 3.0 mg Luminate compared to Avastin
Final readout Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved 5
US Phase IIb DME (DEL MAR) Study
Stage 2 – 5 months, 75 subjects targeted3 monthly loading injectionsTesting additional treatment schemes:
Adjunct therapy (baseline anti-VEGF then Luminate monotherapy) added
Combination therapy with Avastin addedFinal readout Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved 6
washout or Treatment-naïve
Baseline 1 2 3 4 5Months
US Phase IIb Early DR/ PVD (PACIFIC) Study
7
100 subjects with NPDR without PVDUp to 3 intravitreal monthly injections - 1.0, 2.0, 3.0, 4.0 mg
Luminate vs BSSNew indication with novel endpoint - PVD induction based on
B-scan and/or OCTDuke reading center for endpoint gradingStudy completion targeted for Q1 2017
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
washout or treatment naïve
Baseline 1 2 3 4 5Months
Moving Forward With Luminate®
Differentiated mechanisms of action with unique benefits Anti-integrin vs. anti-VEGF platform Increased durability in anti-
angiogenesis New treatment options Evaluating mono-therapy, combo
therapy, and treat/maintain therapy Better safety profile ~400 subjects
treated In multiple Phase 2 US studies in
DME & PVD All Phase 2 studies readout in next 6-
9 months
Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved8
9Copyright 2016 by Allegro Ophthalmics, LLC, All Rights Reserved
Thank You
Confidential: Allegro Ophthalmics, LLC10