Allegro

Luminate® for the
Treatment of Retinal Diseases
Ophthalmology Innovation Summit
November 12, 2015
Vicken Karageozian, MD
Chief Technical Officer
Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved

Allegro Ophthalmics: Integrin Peptide
Therapy for Vitreo-Retinal Eye Diseases
2
 Mid-stage biotechnology company
 In multiple Phase 2b US Studies in DME &
PVD
 Phase 2b VMT – met primary endpoint
 Differentiated mechanisms of action with
unique benefits
 Anti-integrin vs. anti-VEGF
 3+ months durability in DME and wAMD
 Robust vitreolysis
 Strong safety and efficacy profile with
>400 human injections to date
 Collaboration with strategic partners

• 1st in class anti-integrin peptide
• Potency comparable to anti-VEGF in mono-therapy
• 3+ months durability off-treatment
• Robust vitreolysis with an excellent safety profile
Anti-angiogenesis Vitreolysis
DME
US Phase 2b
Data Q3 16
Wet AMD
US Phase 2
Start mid 2016
VMT
US Phase 2b
Met 1º Endpoint
PVD for NPDR
US Phase 2b
Data Q3 16
3

4
Vitreolysis

Key Market Differentiators for Luminate®
5
Jetrea
Safety
Serious neurotoxicity
Retinal tears and
detachment
Very well-tolerated; no
significant safety issues
Efficacy
26% efficacy rate in phase
3 studies
65% efficacy rate in latest
phase 2 study
No competition in PVD
Vitreolysis: VMT and PVD

 At least 100 subjects in 4 arms with VMT with or without MH
 Double masked, placebo-controlled, randomized, multi-center study in the
US and Eastern Europe
 2.0, 2.5 and 3.2mg Luminate® vs BSS
 3-month study with evaluation after 1, 2 and 3 monthly injections
 Primary endpoint: resolution of VMT by OCT by end of study (day 90)
 Enrollment and endpoint determinations made by Duke Reading Center
Phase IIb VMT Study: Design
6
45 day washout or
treatment naïve
Baseline 1 2 3
Months

Phase IIb VMT Study: Safety
 106 subjects enrolled from US and E. European sites
 Excellent Safety Profile:
 No study subjects in any of the three groups
experienced:
 Significant intraocular inflammation
 Cataract changes
 IOP changes
 Retinal tears
 Retinal detachments
 Neurotoxicity - afferent pupillary defects
7

Phase IIb VMT Study: Topline Efficacy
8Copyright 2015 by Allegro Ophthalmics, LLC, All Rights Reserved
Baseline Day 90

Phase IIb VMT Study: Statistical Analysis
• Phase 2 study met its primary endpoint with 65%
efficacy rate of VMT release vs 10% for BSS control
• 3.2mg Luminate® vs BSS
• This result was statistically significant at a 95%
confidence level at p=0.0129
• Data suggests pathway to phase 3
• Data confirms Luminate® robust vitreolytic activity
in human subjects
9

US Phase IIb PVD (PACIFIC) Study
10
 100 subjects with non-proliferative DR without PVD
 Up to 3 intravitreal monthly injections - 1.0, 2.0, and 3.0 mg
Luminate vs BSS
 PVD induction in diabetics closely associated with protection
against PDR progression
 New indication with novel endpoint
 Duke reading center for endpoint grading
 First patient enrolled 09/15
 Top line data Q3 2016
90 day washout
Baseline 1 2 3
Months

11
Anti-angiogenesis

Key Market Differentiators for Luminate®
12
Avastin
Lucentis
Eylea
Frequency of
injections
Injections every
4-8 weeks
Injections every
12 weeks
Target patient
population
40-50% of current disease
population (all 3 drugs in
anti-VEGF)
Expanded treatment
population (new MOA)
Anti-angiogenesis: DME & Wet AMD

• End-stage patients,
many not responding
to anti-VEGF
• Mean peak BCVA
improvement: 10 letters
(or ~2 lines) 3 months
off-treatment
• 8 patients improved
3+ lines
• Improvements held 3+
months off-treatment
• Corresponding
improvement of BCVA
and CMT
• No patients lost vision
Phase Ib/IIa DME Study: BCVA in All Subjects
13
9.7
9.3
11.0 11.0 9.1
0
4
8
12
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
0.0
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Improvement in BCVA (ETDRS
letters converted from Snellen)

• Mean peak
improvement in
OCT CMT: 31%
for all subjects
• Improvement
held until Day 150
(3 months off-
treatment)
• Improvements
ranged from 20-
80% reduction in
CMT
Phase Ib/IIa DME Study: OCT CMT in All Subjects
14
461
439
390 359
387
350
450
550
0 Days 30 Days 60 Days 90 Days 120 Days 150 Days
519
N=15
30 Days Off
Treatment
60 Days Off
Treatment
90 Days Off
Treatment
Central Macular Thickness
(microns)

US Phase IIb DME (DEL MAR) Study
 DME study comparing 1.0, 2.0, and 3.0 mg Luminate to
Avastin for extended durability
 Modeled after phase 1 POC DME study that showed 3+
months durability in monotherapy
 105 of 135 subjects enrolled thus far
 Efficacy endpoints focused on:
 BCVA and OCT central subfield thickness
 Increased durability: efficacy 3 or 4 months off tx in monotherapy
vs Avastin
 Study completion targeted for Q3 2016
15

Moving Forward With Luminate®
 Differentiated mechanisms of action with
unique benefits
 Anti-integrin vs. anti-VEGF platform
 Increased durability in anti-angiogenesis
 Robust vitreolysis
 Strong safety profile with >400 human
injections
 Top line data in Phase 2b VMT, met primary
endpoint
 In multiple Phase 2b US Studies in DME &
PVD ongoing
16

17
Thank You

Allegro

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