Graybug Vision Presents Top Line Results of Phase 1/2a ADAGIO Study at Hawaiian Eye & Retina 2019
The ADAGIO study met the primary endpoints of safety and tolerability without dose limiting toxicities, drug-related serious adverse events or inflammation.
Graybug Vision, Inc., a clinical stage pharmaceutical company developing
potentially transformative therapies for ocular diseases, today
announced positive top line results for the ADAGIO study, a Phase 1/2a
study of intravitreal GB-102 (sunitinib malate) in patients with wet
age-related macular degeneration (AMD), the leading cause of blindness
in the developed world for people age 50 and older. These data were
presented by David S. Boyer, M.D., of Retina Vitreous Associates,
Beverly Hills, CA, during a presentation of “New Developments in Drug
Therapy for Retinal Disorders” at the 2019 Hawaiian Eye & Retina annual
meeting in Kona, Hawaii.
The ADAGIO study met the primary endpoints of safety and tolerability
without dose limiting toxicities, drug-related serious adverse events or
inflammation. Secondary outcomes demonstrated evidence of stability and
maintenance of visual acuity and central retinal thickness that was
durable over at least 6-months as measured by eye chart readings and
optical coherence tomography. OCT measurements showed
statistically significant (P<0.05) maintenance of reduction in the
central subfield thickness at all monthly visits compared to historical
pre-GB-102 measures. Rescue treatment was available for those patients
who met criteria.
“We are very encouraged with results obtained from our clinical study of
GB-102,” said Jerry Cagle, Ph.D., acting CEO of Graybug Vision. “In our
ADAGIO study, GB-102 demonstrated safety and efficacy, with a duration
of effect reaching 6 - 8 months from a single intravitreal injection.
Our product candidate has the potential to be a best-in-class
pan-anti-VEGF inhibitor for the treatment of this vision threatening
retinal disease which affects approximately 1.75 million people in the
United States alone.”
“These study results are highly encouraging. GB-102 holds promise as a
longer duration, non-surgical option to help reduce the need for
repeated interventions, thus making wet AMD more manageable in clinical
practice,” said Dr. Boyer.
Additional data analyses of the ADAGIO Phase 1/2a clinical study are
ongoing and will be presented at these future medical meetings:
-
Angiogenesis, Exudation, and Degeneration
Bascom
Palmer Eye Institute, Miami, Florida
David S. Boyer, M.D., Retina
Vitreous Associates, Beverly Hills, CA
Saturday, February 9, 2019
-
Macula Society Meeting
Hyatt
Regency, Bonita Springs, Florida
Pravin U. Dugel, M.D., Retinal
Consultants of Arizona
Thursday, February 14, 2019
Planning for the GB-102 Phase 2b clinical study is underway and
enrollment is expected to begin in 2019.
About GB-102
GB-102 is a depot formulation of sunitinib malate intended for
intravitreal (IVT) injection. The formulation consists of microparticles
made from poly-lactic-co-glycolic acid (PLGA) and methoxy-polyethylene
glycol (mPEG)-PLGA. The mPEG component is a proprietary hydrophilic,
biocompatible surface treatment designed to eliminate inflammation
typically associated with ocular administration of PLGA. The surface
treatment also facilitates microparticle aggregation upon IVT injection
to form an implant-like depot in the inferior vitreous. After IVT
injection, the microparticles gradually release sunitinib malate and
biodegrade into lactic and glycolic acid, which are naturally cleared
from the body.
Sunitinib malate is small molecule receptor tyrosine kinase inhibitor
that is a potent inhibitor of VEGFR-1, -2, and -3, receptors known to
play an influential role in the development and progression of wet AMD.
About the ADAGIO Phase 1/2a Clinical Study
The ADAGIO clinical trial was an open-label, single dose study that
enrolled 32 patients from 8 centers located in the United States.
Patients enrolled in the study were previously treated with at least
three prior intravitreal injections of any anti-VEGF agent current
standard of care treatment (aflibercept, bevacizumab, or ranibizumab),
and had to demonstrate a response to anti-VEGF treatment. Additionally,
patients had to show evidence of active disease prior to enrollment as
assessed by evidence of fluid on OCT and/or leakage on fluorescein
angiography and these findings were confirmed by a masked third-party
reading center. Patients enrolled in the study received a single
intravitreal dose of GB-102 (0.25, 0.5, 1, or 2 mg) in escalating dose
cohorts with eight patients in each cohort. Patients averaged 59.3 days
from their last anti-VEGF treatment to their first and only GB-102
treatment. Patients were followed monthly for 8 consecutive months. At
each monthly visit, adverse events, best-corrected visual acuity (Early
Treatment of Diabetic Retinopathy [ETDRS] procedure), slit-lamp
biomicroscopy, fundoscopy and OCT data were collected.
About Wet Age-related Macular Degeneration (wet AMD)
Wet (neovascular) age-related macular degeneration, is the leading cause
of blindness in the developed world in individuals aged 50 years or
older. It is caused by the formation of abnormal and leaky new blood
vessels behind the retina, termed choroidal neovascularization. The
leakage of fluid and protein from the vessels, causes retinal
degeneration and leads to severe and rapid loss of vision. According to
the National Eye Institute, the prevalence of wet AMD among adults 40
years or older in the U.S. alone is estimated at 1.75 million people. In
addition, more than 200,000 new cases are diagnosed in the U.S. annually.
About Graybug Vision
Graybug Vision is a clinical stage pharmaceutical company developing
novel products for the treatment of ocular diseases. The company’s
proprietary injectable products are designed to enable less frequent
administration to reduce the burden of treatment for patients and their
physicians. The company’s lead clinical-stage injectable product,
GB-102, has the potential to be a best-in-class pan-anti-VEGF inhibitor
for the treatment of wet AMD. Graybug Vision has also selected a lead
compound to treat primary open angle glaucoma (POAG) with the potential
to provide a best-in-class treatment lasting at least 4 months after a
single injection. For more information, please visit www.graybug.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190121005424/en/