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CLG561

Phase 2

Geographic Atrophy | Small molecule | Other |Alcon Inc.|Last Updated: May 30, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedSHAM_CONTROLLED
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02515942CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)PHASE2 COMPLETED 114Sep 25, 2015Dec 1, 2017May 30, 2019 -
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Study Endpoints
Primary Endpoints
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug
Up to Day 421

A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.

Mean Change From Baseline in Intraocular Pressure (IOP)
Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)
Baseline (Day 1), Day 337

Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.

Secondary Endpoints
Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF
Baseline (Day 1), Day 85, Day 169, Day 253
Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF
Baseline (Day 1), Day 421
Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CLG561EXPERIMENTALCLG561 10 mg, one IVT injection every 28 days for a total of 12 injections
CLG561+LFG316EXPERIMENTALCLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections
Sham InjectionSHAM_COMPARATOROne sham injection every 28 days for total of 12 sham injections
Interventions
NameTypeDescription
CLG561DRUG -
LFG316DRUG -
Sham injectionDRUGEmpty syringe (without a needle) placed against the eye
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Sign written informed consent form; * Geographic atrophy in both eyes; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Pregnant or lactating women and women of child-bearing potential; * Any medical condition (systemic or ophthalmic) that may p...

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