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Luminate® for the Treatment of Retinal Diseases
Ophthalmology Innovation SummitOctober 13, 2016
Vicken Karageozian, MDPresident and Chief Medical Officer
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.1
2
What Does Allegro Offer?First in class anti-integrin product (Luminate®) with novel MOA for anti-angiogenesis and vitreolysis
Top line results of Phase 2b DME (Stage 1) monotherapy study released today
~400 human subjects treated with well-tolerated safety
Most programs significantly de-risked Composition of matter IP, solid PK, Tox, and CMC packages
Late stage development with multiple programs in phase 2b or laterDME phase 2b DEL MAR Stage 2 Q2 2017PVD phase 2b PACIFIC data lock Q1 2017VMT phase 3 ready
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
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Anti-Angiogenesis
DME Wet AMD
BenefitsIncreased durability
Better safety
New MOA with new treatment options
Vitreolysis
PVD VMT
BenefitsVitreolysis and PVD induction
Better safety
New MOA with new treatment options
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
Human Clinical Studies Update:DEL MAR DME Phase 2b –
(Stage 1) Top Line
4Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
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136 subjects enrolled across 32 US sites1.0, 2.0, and 3.0 mg Luminate (3 injections) compared to Avastin (6 injections)Luminate vs. Avastin in monotherapyPrimary endpoint was 12 weeks off Luminate treatment; efficacy in mean BCVA and OCT improvementsQ3 data lock for Stage 1 study
DEL MAR US Phase IIb DME Study (Stage 1)
Phase 2b – Stage 1: 6 months follow up
washout or treatment naïve
Baseline 1 2 3 4 5 6Months
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
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Change in BCVA Letters Read Over Time With 95% Confidence Interval
DEL MAR US Phase IIb DME Study (Stage 1)
Study Met Primary EndpointMean BCVA non-inferiority at study week 20 (≤3 letters BCVA)7.0 letters vs 5.2 letters12 weeks off Luminate vs 4 weeks off Avastin
0 4 8 12 16 20 24-10
-5
0
5
10
15
20
2.8 2.9 1.84.7 5.2
2.6
3.55.8 6.1 6.4 7.0 6.3
Luminate 1.0 mgAvastin 1.25 mg
Mai
n C
hang
e
Week from Baseline
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
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Change in Central Retinal Thickness Over Time With 95% Confidence Interval
DEL MAR US Phase IIb DME Study (Stage 1)
0 4 8 12 16 20 24-250
-200
-150
-100
-50
0
50
100
-28.0 -25.0 -28.0-67.0 -77.0 -97.0
-77.0 -85.0-104.0 -120.0 -104.0 -106.0
Luminate 1.0 mgAvastin 1.25 mg
Mai
n C
hang
e
Study Met Secondary EndpointMean OCT CMT non-inferiority at study week 20 (≤30µ)
-104µ vs -77µ at study week 20, 12 weeks post Luminate load-106µ vs -97µ at study week 24, 16 weeks post Luminate load
Week from Baseline
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
8Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
DEL MAR US Phase IIb DME Study (Stage 1)
Baseline
Study Week 16(8 weeks post load)
Study Week 20(12 weeks post load)
Example #1: Luminate
9Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
DEL MAR US Phase IIb DME Study (Stage 1)
Baseline
Study Week 16(8 weeks post load)
Example #2: Luminate
Study Week 20(12 weeks post load)
10Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
DEL MAR US Phase IIb DME Study (Stage 1)Example #3:
LuminateBaseline
Study Week 16(8 weeks post load)
Study Week 20(12 weeks post load)
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DEL MAR US Phase IIb DME Study (Stage 1)
Non-inferiority to anti-VEGF with half the number of injections
Met secondary endpoint by OCT central macular thickness
Met primary endpoint by best corrected visual acuity
Data confirms 12 week monotherapy durability
Top line data demonstrates Luminate with
non-inferiority to Avastin at the
primary endpoint of study week 20
Robust activity with new MOA of this new anti-integrin class of drugs in DME
Very comparable safety reporting between treatment and control groups
No drug related SAEs reported for the Luminate arms
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
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Moving Forward With Luminate®
Excellent safety profile ~400 subjects treated to date
In multiple Phase 2 US studies in DME (stage 2) & PVD that will readout in next ~9 months
Differentiated mechanisms of action with unique benefits
New MOA – Anti-integrin vs. anti-VEGFSimilar potency to Anti-VEGFPotent enough for monotherapy12 weeks durability in DMENew treatment optionsShort term path to commercial availability
Phase 2 DME monotherapy study: met primary endpoint
Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
Anticipate Phase 3 studies to be conducted with pre-filled, disposable syringes developed by Allegro
Thank You
13Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.
14Copyright 2016, All Rights Reserved, Allegro Ophthalmics, LLC.