UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology
company developing therapeutics to slow, halt, or reverse diseases
of aging, today announced 24-week data from its Phase 1 single
ascending dose (SAD) safety study of UBX1325 in patients with
advanced disease from diabetic macular edema (DME) or wet
age-related macular degeneration (AMD). A majority of patients with
DME across all doses had rapid improvements in vision, and patients
in the higher dose cohorts showed a mean gain of 9.5 ETDRS letters
in best-corrected visual acuity (BCVA) at 24 weeks following a
single injection of UBX1325. Similarly, a majority of wet AMD
patients treated with UBX1325 showed rapid gains in visual acuity,
which were maintained through 12 weeks. In most patients, central
subfield thickness (CST) remained stable through the study period.
UBX1325 Well-Tolerated at All
DosesThe study enrolled a total of 19 patients with
advanced DME (n=8) and wet AMD (n=11) for whom anti-VEGF therapy
was no longer considered beneficial. UBX1325 was well-tolerated at
all doses tested (through 10 mcg) with no dose-limiting toxicities
and no reported incidence of inflammation.
Results from Patients with Diabetic
Macular Edema Treated with UBX1325 The Phase 1 data show
rapid improvements in visual acuity as measured by BCVA in patients
with DME, with the majority of patients demonstrating sustained
responses through 24 weeks:
- Across all DME patients enrolled
(n=8), there was an improvement in visual acuity in 6 of 8 patients
at 12 weeks, and in 5 of 8 patients at 24 weeks
- In the higher dose cohorts (5, 10
mcg), patients had a mean improvement of 9.5 ETDRS letters from
baseline at 24 weeks
- Amongst all DME patients, 62.5%
gained 5 or more letters at 24 weeks, and 50% gained 10 or more
letters also at 24 weeks
- In the majority of patients with
DME, CST remained stable through 24 weeks
“A 10 letter gain in DME patients, maintained
through six months, is an impressive outcome, and is particularly
noteworthy considering that it was achieved with a single
injection,” said Arshad Khanani, M.D., M.A., managing partner of
Sierra Eye Associates. “Hard-to-treat patients require as many as
10 injections in the first year of treatment to see full benefits
from currently available anti-VEGF therapies. A treatment that
reduces the frequency of injections while showing meaningful and
sustained improvements in BCVA would be of huge value for patients
and physicians.”
Results from Patients with Wet
Age-Related Macular Degeneration Treated with UBX1325 The
Phase 1 study included 11 wet AMD patients (4 in the SAD cohort,
and an additional 7 in an expansion cohort). A majority of patients
showed rapid improvements in visual acuity:
- Across all evaluable patients with
wet AMD enrolled (10 of 11), there was an improvement in visual
acuity in 7 of 10 patients at 8 weeks, and in 5 of 10 patients at
12 weeks
- 2 of 3 patients in the SAD cohort
maintained their visual acuity gain through 24 weeks
- Within the ten evaluable patients
with wet AMD, CST remained stable through 12 weeks; this trend was
also observed in the three evaluable patients with wet AMD at 24
weeks, and 2 of those 3 patients showed resolution of most
subretinal fluid
“Patients with wet AMD will lose vision without
treatment and have a worse prognosis than patients with DME, which
is why the letter gain seen in the AMD cohort is so meaningful,”
said Robert Bhisitkul, M.D., Ph.D., professor of ophthalmology and
director of the Retina Fellowship at University of California, San
Francisco. “The efficacy that we are seeing in AMD patients
provides a convincing rationale for advancing this program into
additional clinical studies.”
“We have now followed advanced DME and AMD
patients for 24 weeks, and see clear evidence of rapid and
sustained responses from a single injection of UBX1325,” said
Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The
improvements in vision and retinal structure suggest that this new
mechanism of action – the selective elimination of senescent cells
in diseased retinal tissue – has the potential for
disease-modifying effect in a large proportion of patients
struggling to manage their disease.”
UNITY’s Phase 2 study of UBX1325 in DME is
underway, with 12-week safety and efficacy data anticipated in the
first half of 2022. A Phase 2 study in wet AMD is planned for the
first half of 2022, with 12-week data expected in the second half
of the year.
Investor Conference Call at 8:00 a.m. ET
TodayUNITY will host a video conference call and webcast
for investors and analysts on Tuesday, November 9 at 8:00 a.m. ET
to discuss the most recent UBX1325 clinical data. Drs. Khanani and
Bhisitkul, as well as members of the UNITY senior management team
will lead the discussion on the 24-week DME and 12-week wet AMD
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. 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 UBX1325UBX1325 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 (DR) 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 DME, AMD, and DR.
About UNITYUNITY 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 StatementsThis
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
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