Graybug Vision Reports Preliminary Topline Results from Phase 2b ALTISSIMO Trial
March 09 2021 - 6:30AM
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 preliminary topline data from the 12-month
treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the
treatment of wet age-related macular degeneration (wet AMD),
Graybug’s proprietary microparticle depot formulation of sunitinib
malate injected intravitreally.
The ALTISSIMO trial is a masked and controlled Phase 2b
dose-ranging study of two doses of GB-102 with a single control arm
of patients on aflibercept, conducted across 33 study sites in the
United States. The primary endpoint is median time to first
supportive therapy with a vascular endothelial growth factor (VEGF)
inhibitor, and secondary endpoints are pharmacodynamics measures of
mean change of best-corrected visual acuity (BCVA) from baseline
and mean change of central subfield thickness (CST) of the retina
from baseline.
The trial was originally designed to evaluate two separate doses
of GB-102, 1mg and 2mg, injected every 6 months as compared with
aflibercept injected every 2 months. Based on the results of an
interim safety analysis, the 2mg dose was discontinued after the
initial dose, and all patients in that arm were switched to 1mg for
their second dose.
Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of
median time to first supportive therapy was 5 months. Furthermore,
48% of patients did not require supportive therapy for at least 6
months, and 62% of patients for at least 4 months or more, at least
once during the trial. Overall, the 1mg dose performed better than
the 2mg dose.
Overall, GB-102 1mg was well-tolerated. There were no
drug-related serious adverse events, and the majority of
drug-related adverse events were mild to moderate. Medication was
detected in the anterior chamber in less than 10% of GB-102 1mg
injections, and no adverse event required surgical intervention.
There was no vision-threatening inflammation observed, and there
was no increase in intraocular pressure reported.
CST and BCVA were measured as secondary endpoints. CST in the
GB-102 1mg arm was consistent with the study control arm. The mean
change from baseline for BCVA for all 20 completers was
approximately 9 letters lower across all time points, on average,
than that observed in the study control arm.
At the end of the treatment phase, patients were surveyed as to
their satisfaction with their treatment compared to their treatment
prior to entering the trial. Over 80% of responding patients who
had been treated with GB-102 reported that they were equally or
more satisfied with their treatment, similar to the satisfaction
expressed by patients treated with aflibercept.
ALTISSIMO is continuing through a six-month extension in which
28 of the 50 patients who completed their Month 12 visit were
eligible and agreed to continue masked clinical monitoring.
Patients will continue with monthly visits until the point at which
they require additional supportive therapy, up to a maximum of 6
months. As of today, 22 patients have successfully completed 2
months or more of this six-month extension period without the need
for further treatment.
Graybug will determine next steps after completing the full
analysis of the ALTISSIMO results, which is anticipated to occur in
the second quarter.
“We are very grateful to all patients, investigators and staff
who participated in the ALTISSIMO trial, and look forward to the
read-out of the extension trial data,” said Parisa Zamiri, MD, PhD,
Chief Medical Officer of Graybug.
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 microparticle depot 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 is also using its proprietary technologies to develop
GB-401, an injectable depot formulation of a beta-adrenergic
blocker prodrug, for primary open-angle glaucoma, with a dosing
regimen of once every six months or longer, and GB-103, a
longer-acting version of GB-102, designed to maintain therapeutic
drug levels in the retinal tissue for 12 months with a single
injection. Founded in 2011 on the basis of technology licensed from
the Johns Hopkins University School of Medicine, Graybug is
headquartered in Redwood City, California. 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,
interactions with regulatory authorities, its ability to advance
GB-102, GB-103, GB-401, or any future product candidate through
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 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 for the year ended December 31, 2020, and 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 |
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
From Sep 2023 to Sep 2024