UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology
company developing therapeutics to slow, halt, or reverse diseases
of aging, today announced 12-week data from its ongoing Phase 1
safety study of UBX1325 in patients with advanced disease from
diabetic macular edema (DME) and wet age-related macular
degeneration (AMD) for whom anti-VEGF therapy was no longer
considered beneficial. The data show strong and sustained responses
following a single injection of UBX1325 out to 12 weeks and add
substantively to the previously reported 8-week dataset, which
provided initial evidence of efficacy. The 24-week data from the
study is expected before the end of the year.
UBX1325, a small molecule inhibitor of Bcl-xL
and the first senolytic drug candidate for ophthalmologic diseases
targeting a distinctive biologic pathway from anti-VEGF therapies,
continues to be well-tolerated with no treatment-related adverse
events or dose-limiting toxicities up to 12 weeks. Additionally,
UBX1325 showed sustained responses in key clinical measures of
disease progression in most patients through 12 weeks, including
substantial improvements in best-corrected visual acuity (BCVA) and
central subfield thickness (CST).
“It is promising to see improvements in vision
sustained over three months after a single dose in these patients
with advanced vascular eye disease, especially considering that
these patients had gone at least six months without standard of
care anti-VEGF therapy by this point,” said Robert Bhisitkul, M.D.,
Ph.D., professor of ophthalmology and director of the Retina
Fellowship at University of California, San Francisco. “There are
limited treatment options for patients who do not benefit from
standard of care, so a novel therapeutic approach like UBX1325
could provide significant benefit as an alternative or complement
to anti-VEGF treatments.”
Treatment of patients with a single UBX1325
injection resulted in the following clinical changes at 12 weeks
following treatment:
Gain in ETDRS Letters from Baseline in
Best-Corrected Visual Acuity (BCVA)
- Overall (across all doses): 8 of 12
patients showed a gain in ETDRS letters from baseline in BCVA at 12
weeks
- In high dose groups (5, 10 mcg): 5
of 6 patients showed a gain in ETDRS letters from baseline in BCVA
at 12 weeks
Decrease in Central Subfield Thickness (CST)
- Overall (across all doses): 6 of 10
patients had a decrease (improvement) in CST at 12 weeks, excluding
two patients who received anti-VEGF rescue therapy following
progression of underlying disease
- In high dose groups (5, 10 mcg): 3
of 5 patients showed decrease in CST at 12 weeks, excluding one
patient who received anti-VEGF rescue following progression of
underlying disease
The Phase 1, open-label, single-ascending dose
study includes 12 patients with advanced DME or wet AMD who were no
longer expected to benefit from anti-VEGF therapies. Patients
enrolled in the study could not have received an anti-VEGF therapy
or corticosteroid for three months prior to receiving a single dose
of UBX1325. At 12 weeks following treatment with study drug,
UBX1325 demonstrated a favorable safety profile supporting further
clinical development. There were no dose-limiting toxicities
observed, with two nonserious, nondrug-related adverse events
reported through 12 weeks.
“We are excited by the trajectory of the data
showing both a rapid response and sustained improvements in vision
and retinal structure in most patients through 12 weeks following a
single injection of UBX1325,” said Anirvan Ghosh, Ph.D., chief
executive officer of UNITY. “The consistency of response at 8 and
12 weeks suggests that the functional gains seen to date may be
sustained beyond 12 weeks. These data further support our Phase 2a
Proof of Concept study in patients with DME, which is already
underway, and we anticipate the 12-week safety and efficacy data
from that study in the first half 2022.”
UNITY expects to share 8-week data from an
additional cohort of patients with wet AMD, as well as complete
24-week data of the original cohort from the Phase 1 single
ascending dose study, before the end of the year.
Investor Conference Call at 8:00 a.m. ET
TodayUNITY will host a conference call and webcast for
investors and analysts on Tuesday, October 5 at 8:00 a.m. ET to
discuss the most recent UBX1325 clinical data. Dr. Bhisitkul and
members of the UNITY senior management team will lead the
discussion on the 12-week data results. The live webcast can be
accessed in the “Investors and Media” section of our
website, www.unitybiotechnology.com, under “Events &
Presentations” or by clicking here. You may also listen to the
call by dialing (877) 235-8637 within the U.S. or (704)
815-6400 outside the U.S. and providing conference ID
5226618. A replay will be available two hours after the completion
of the call and can be accessed in the “Investors & Media”
section of our website, under “Events and
Presentations.” About UBX1325
UBX1325 is an investigational compound being
studied for age-related diseases of the eye, including diabetic
macular edema (DME), age-related macular degeneration (AMD), and
diabetic retinopathy that is not approved for any use in any
country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a
member of the Bcl-2 family of apoptosis regulating proteins.
UBX1325 is designed to inhibit the function of proteins that
senescent cells rely on for survival. In preclinical studies, UNITY
has demonstrated that targeting Bcl-xL with UBX1325 preferentially
eliminated senescent cells from diseased tissue while sparing cells
in healthy tissue. UNITY’s goal with UBX1325 is to
transformationally improve real-world outcomes for patients with
DR, DME, and AMD.
About UNITY
UNITY is developing a new class of therapeutics
to slow, halt, or reverse diseases of aging. UNITY’s current focus
is on creating medicines to selectively eliminate or modulate
senescent cells and thereby provide transformative benefit
in age-related ophthalmologic and neurologic diseases.
More information is available
at www.unitybiotechnology.com or follow us
on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking
statements including statements related to UNITY’s understanding of
cellular senescence and the role it plays in diseases of aging, the
potential for UNITY to develop therapeutics to slow, halt, or
reverse diseases of aging, including for ophthalmologic and
neurologic diseases, our expectations regarding potential benefits,
activity, effectiveness, and safety of UBX1325, the potential for
UNITY to successfully commence and complete clinical studies of
UBX1325 for DME, AMD, and other ophthalmologic diseases, the
expected timing of results of our studies of UBX1325, the timing of
the expected commencement, progression, and conclusion of our
studies including those of UBX1325, and UNITY’s expectations
regarding the sufficiency of its cash runway. These statements
involve substantial known and unknown risks, uncertainties, and
other factors that may cause our actual results, levels of
activity, performance, or achievements to be materially different
from the information expressed or implied by these forward-looking
statements, including the risk that
the COVID-19 worldwide pandemic may continue to
negatively impact the development of preclinical and clinical drug
candidates, including delaying or disrupting the enrollment of
patients in clinical trials, risks relating to the uncertainties
inherent in the drug development process, and risks relating to
UNITY’s understanding of senescence biology. We may not actually
achieve the plans, intentions, or expectations disclosed in our
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. Actual results or events could
differ materially from the plans, intentions, and expectations
disclosed in the forward-looking statements we make. The
forward-looking statements in this press release represent our
views as of the date of this release. We anticipate that subsequent
events and developments will cause our views to change. However,
while we may elect to update these forward-looking statements at
some point in the future, we have no current intention of doing so
except to the extent required by applicable law. You should,
therefore, not rely on these forward-looking statements as
representing our views as of any date subsequent to the date of
this release. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of UNITY in general, see UNITY’s most
recent Quarterly Report on Form 10-Q for the quarter
ended June 30, 2021, filed with the Securities and
Exchange Commission on August 10, 2021, as well as other
documents that may be filed by UNITY from time to time with
the Securities and Exchange Commission.
MediaCanale CommunicationsJason
SparkJason.spark@canalecomm.com
UNITY Biotechnology (NASDAQ:UBX)
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