Graybug Vision Reports Analysis of Data from the Six-Month Extension Study of the ALTISSIMO Phase 2b Trial in Wet AMD
September 28 2021 - 7:30AM
Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage
biopharmaceutical company focused on developing transformative
medicines for the treatment of diseases of the retina and optic
nerve, today provided full-data analysis from the 18-month Phase 2b
ALTISSIMO trial of GB-102 for the treatment of wet age-related
macular degeneration (wet AMD), Graybug’s proprietary formulation
of sunitinib malate injected twice-a-year intravitreally.
The ALTISSIMO trial was a masked and controlled Phase 2b
dose-ranging study of two doses of GB-102, 1mg and 2mg, with a
single control arm of patients on 2mg aflibercept, conducted across
33 study sites in the United States. The primary endpoint was
median time to first supportive therapy with a vascular endothelial
growth factor (VEGF) inhibitor, and secondary endpoints were safety
and pharmacodynamics, measured as mean change in best-corrected
visual acuity (BCVA) and mean change in central subfield thickness
(CST) of the retina. As previously reported, the development of
GB-102 2mg was terminated in 2020 following an interim safety
analysis, and ALTISSIMO was not powered to assess non-inferiority
to aflibercept.
ALTISSIMO comprised two phases, the first of which was a
12-month treatment phase, or Core Study, in which GB-102 patients
were dosed at Day 1 and Month 6, while a control arm received
aflibercept every other month. The second phase of ALTISSIMO was a
six-month extended observation phase, or Extension Study, in which
patients were monitored without additional treatment to determine
the duration of effect measured from their last treatment during
the Core Study. Participation in the Extension Study was voluntary,
but only patients who completed all study visits, and did not
require supportive therapy at their Month 12 visit during the Core
Study, were eligible. 58% of the patients who completed the Core
Study were eligible and agreed to enter the Extension Study, with
11 patients participating in the GB-102 1mg arm.
By its design, patients could not achieve longer than a
six-month duration during the Core Study. The Extension Study
provided up to an additional six months for patients to demonstrate
longer duration, which resulted in 55% of GB-102 1mg patients
experiencing a treatment duration of 12 months or longer, while
maintaining visual acuity and central retinal thickness. This is
the longest duration ever achieved with an intravitreal injection
in a randomized, masked, and controlled clinical trial in wet AMD.
In addition, the injection burden was reduced by 73% on an
annualized basis for those GB-102 1mg patients who participated in
the six-month Extension Study.
As in the Core Study, GB-102 1mg continued to be well-tolerated
and maintained a favorable safety profile during the Extension
Study. No drug-related adverse events or vision-threatening
inflammation were reported.
“The Extension Study gave us our first opportunity to see
duration beyond six months in a masked and controlled trial, and we
are very excited that the majority of patients volunteering for
extended observation achieved a treatment duration of 12 months or
longer,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of
Graybug. “Furthermore, the significant reduction in injection
burden continued throughout the Extension Study and showed that
GB-102 1mg has the potential to significantly improve compliance
compared to the current standard of care,” Dr. Zamiri
concluded.
Graybug continues to optimize its technology platform and is
developing additional formulations that have the potential to
preserve the durability of GB-102 1mg microparticles while
minimizing the risk of dispersion. These new and enhanced
formulations, including injectable implants, may also simplify the
drug reconstitution process and the injection technique, both of
which are sources of variability in clinical outcomes. These
innovations have already been incorporated into the development
programs of both GB-102 and GB-401. Graybug anticipates that its
GB-401 implant program for glaucoma will enter a Phase 1 trial in
the second half of 2022. Given the 12-month or longer duration
observed with GB-102 in the ALTISSIMO 18-month trial, Graybug
decided to stop the further development of GB-103, which was
designed to maintain therapeutic drug levels in the retinal tissue
for 12 months with a single injection.
“We are encouraged by the Extension Study data that indicate a
class-leading durability of GB-102 1mg of 12 months, or longer,”
said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision.
“These data further support the significant commercial opportunity
that GB-102 1mg could represent. Our search for a partner to fund
the further clinical development of GB-102 is ongoing.”
About Graybug
Graybug is a clinical-stage biopharmaceutical company focused on
developing transformative medicines for the treatment of diseases
of the retina and optic nerve. The company’s proprietary ocular
delivery technologies are designed to maintain effective drug
levels in ocular tissue for six months and potentially longer,
improving disease management, reducing healthcare burdens and
ultimately delivering better clinical outcomes. Graybug’s lead
product candidate, GB-102, a formulation of the pan-vascular
endothelial growth factor (VEGF) inhibitor, sunitinib malate
targeting a six-month or longer dosing regimen, inhibits multiple
neovascular pathways for the intravitreal treatment of retinal
diseases, including wet age-related macular degeneration. Graybug’s
other product candidates developed using its proprietary
technologies also include GB-401, an injectable sustained release
formulation of a beta-adrenergic blocker prodrug, for primary
open-angle glaucoma, with a dosing regimen of once every six months
or longer. Founded in 2011 on the basis of technology licensed from
the Johns Hopkins University School of Medicine, Graybug has
offices in Redwood City, California, and in Baltimore, Maryland.
For more information, please visit www.graybug.vision.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995 including, but not limited
to, statements regarding the company’s clinical pipeline, its
ability to timely identify a partner to fund further development of
GB-102 for wet AMD on reasonable terms if at all, the timing or
outcomes of its interactions with regulatory authorities, its
ability to advance GB-102, GB-401, or any future product candidate
through preclinical or clinical development, its ability to achieve
its anticipated milestones within the timing outlined above or at
all, its ability to conduct planned operations within the evolving
constraints arising from the COVID-19 pandemic, and the timing,
cost, and results of its clinical trials. Forward-looking
statements are subject to risks and uncertainties that may cause
the company’s actual activities or results to differ significantly
from those expressed in any forward-looking statement, including
risks and uncertainties described under the heading “Risk Factors”
in the company’s annual report on Form 10-K filed for the year
ended December 31, 2020, in its subsequent quarterly reports on
Form 10-Q, and in the other reports the company files from time to
time with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date of this press
release, and the company undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date hereof.
Investor ContactIR@graybug.vision(650)
487-2409 |
Media Contactmedia@graybug.vision(404)
384-0067 |
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