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 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 formulation of sunitinib malate injected
twice-a-year 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 safety and pharmacodynamics,
measured as mean change of best-corrected visual acuity (BCVA) and
mean change of central subfield thickness (CST) of the retina.
The ALTISSIMO full-data analysis focused on the GB-102 1mg arm
as compared to aflibercept and the pre-enrollment period, excluding
results from the GB-102 2mg arm. As previously reported, the
development of GB-102 2mg was terminated in 2020 following an
interim safety analysis. The trial was not powered to assess
non-inferiority to aflibercept.
Overall, GB-102 1mg was safe and well-tolerated. No drug-related
serious adverse events or vision-threatening inflammation were
reported. The majority of drug-related adverse events were mild to
moderate. Particle migration to the anterior chamber in patients
treated with GB-102 1mg was reduced by 79% as compared to GB-102
1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs.
3/8), and no surgical interventions were required.
As previously reported, patients in the GB-102 1mg trial arm
(n=21) had a median time to first supportive therapy of five
months, and 48% of patients did not require supportive therapy for
at least six months. An additional analysis showed the injection
frequency was reduced by 58% compared to patients’ treatment prior
to enrollment in the trial.
“Given the constantly changing landscape of long-acting drug
delivery, GB-102 has the potential to significantly reduce the
treatment burden for patients compared to the current standard of
care,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of
Graybug. “The ALTISSIMO results support further exploration of
enhanced formulations of GB-102 for the treatment of wet AMD.”
Although ALTISSIMO was not powered to show statistical
significance, control of CST in patients treated with twice-a-year
GB-102 1mg compared with baseline was similar to bi-monthly
aflibercept, while BCVA trended lower in GB-102 1mg patients as
compared with aflibercept. This trend in visual acuity was
primarily driven by six patients: two patients whose disease was
not well-controlled despite frequent anti-VEGF treatment prior to
enrollment, two patients who experienced adverse events unrelated
to GB-102, and two patients who experienced adverse events related
to dispersion of GB-102 microparticles.
Over the past 18 months, Graybug continued to optimize its
technology platform and initiated the development of additional
formulations, which have the potential to preserve the durability
of GB-102 microparticles while minimizing the risk of dispersion.
These new and enhanced formulations, including injectable implants,
also have the potential to simplify the drug reconstitution process
as well as minimize the injection technique variability. They 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 first half
of 2022.
“We are encouraged by the ALTISSIMO full-data analysis that
indicates favorable safety, extended durability, and
pharmacodynamics of GB-102, and are in the process of designing an
additional trial in wet AMD with enhanced formulations of GB-102
while looking for a partner to fund its further clinical
development,” said Fred Guerard, PharmD, Chief Executive Officer,
Graybug Vision. “We will pause development of GB-103 and GB-102 for
diabetic macular edema while we devote our current cash to
advancing GB-401 through Phase 1 clinical development. Our
opportunistic in-licensing efforts will continue targeting
technologies addressing high unmet medical needs in
ophthalmology.”
Graybug expects to report the results from the on-going
six-month extension period of ALTISSIMO in the fourth quarter of
2021.
Conference Call and Webcast
Graybug’s management will host a webcast and conference call at
8 a.m. ET / 5 a.m. PT today, May 12, 2021, to discuss the ALTISSIMO
clinical results. The live call may be accessed by dialing (844)
955-2748 (domestic) and (929) 517-0407 (international) and entering
the conference ID# 5461708 or via webcast from the IR Events &
Presentations page of the Investors and Media section of Graybug’s
website at
https://investors.graybug.vision/news-events/events-presentations.
Following the live event, a replay will be available at the same
location.
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, 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,
its ability to identify a partner to advance the development of
GB-102 for wet AMD, the timing or outcomes of its interactions with
regulatory authorities, its ability to advance GB-102, GB-103,
GB-401, or any future product candidate through preclinical or
clinical development, its ability to timely secure a partner to
fund further development of GB-102 on reasonable terms if at all,
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 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 |
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