– LNZ100 selected as lead candidate
– Primary endpoint was met with 71% of
participants dosed with LNZ100 achieving three-lines or greater
improvement at 3 hours
– Rapid onset and long duration shown with 71%
of participants achieving three-lines or greater improvement at 30
minutes and 40% at 10 hours
– New Drug Application submission anticipated
in mid-2024
– Company to host a conference call and webcast
today at 8:00 a.m. ET
LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the
“Company”), a late clinical-stage biopharmaceutical company focused
on developing the first aceclidine-based eye drop to improve near
vision in people with presbyopia, today announced positive topline
results from its Phase 3 CLARITY study of two investigational
formulations of aceclidine, LNZ100 and LNZ101, for the treatment of
presbyopia, the inevitable loss of near vision that impacts the
daily lives of nearly all people over 45.
In Phase 3 safety and efficacy trials (CLARITY 1 and 2), our
lead product candidate LNZ100 (1.75% aceclidine) achieved the
primary endpoints and key secondary endpoints, with statistically
significant three-lines or greater improvement in Best Corrected
Distance Visual Acuity (BCDVA) at near, without losing one-line or
more in distance visual acuity. In the vehicle-controlled CLARITY 2
trial, the Day 1 results showed (all p<0.0001):
- Rapid onset: 71% achieved three-lines or greater
improvement at 30 minutes.
- Primary endpoint: 71% achieved three-lines or greater
improvement at 3 hours.
- Long duration: 40% achieved three-lines or greater
improvement at 10 hours.
Near vision improvement was reproducible and consistent across
both CLARITY 1 and 2 throughout the four-week study periods.
LNZ100 was well-tolerated with no serious treatment-related
adverse events observed in the over 30,000 treatment days across
all three CLARITY trials.
LNZ101 showed similar results, including achieving primary and
secondary endpoints in both CLARITY 1 and 2, but did not show
superiority to LNZ100. Based on these results, LENZ selected LNZ100
as its lead product candidate, for which it plans to submit a New
Drug Application (NDA) in mid-2024.
“We are very pleased with the outcome of the CLARITY trials, and
most importantly the strong efficacy and safety profile of LNZ100
observed in patients with presbyopia. We would like to thank our
investigators, clinical sites, and all participants in our study,”
said Eef Schimmelpennink, President and Chief Executive Officer of
LENZ Therapeutics. “We believe these data support LNZ100 as a
potential best-in-class therapy for the treatment of presbyopia.
The high responder rate, rapid onset and long duration across a
broad range of presbyopes ranging from 45 to 75 years of age and
having a refractive range from -4.0 to +1.0D SE are consistent with
features that patients are expecting from an effective treatment
option. Based on these highly encouraging data, we will direct our
focus towards our NDA submission in mid-2024 for LNZ100, and
preparations for commercialization in second half of 2025 upon FDA
approval, with the goal of moving closer to helping many of the 128
million people experiencing symptoms of presbyopia in the United
States.”
“These positive CLARITY study data build on the compelling
results from our INSIGHT trials, demonstrating a robust safety and
efficacy profile for the use of aceclidine to treat presbyopia,”
said Marc Odrich, Chief Medical Officer of LENZ Therapeutics.
“Presbyopes often experience an abrupt change in their daily life
as the symptoms become progressively pronounced starting in their
mid-40s, when reading glasses or other corrective aids often become
necessary to read, text or conduct close-up work. The statistically
significant data and clinically meaningful outcomes observed in the
CLARITY trials support the potential paradigm-shifting impact
LNZ100 can have as an alternative and convenient therapeutic option
to reading glasses.”
CLARITY Phase 3 Study Topline Data Highlights:
CLARITY is a Phase 3 multi-center, double-masked, randomized,
controlled, efficacy and safety study for LNZ100 and LNZ101 for the
treatment of presbyopia. It is comprised of two six-week efficacy
trials, CLARITY 1 and 2, and a six-month safety trial, CLARITY 3.
The trials enrolled a total of 1,059 participants ranging from ages
45 to 75, and a refractive range of -4.0D SE to +1.0D SE, and
included users who previously had LASIK surgery or are
pseudophakes. The primary efficacy endpoint in both CLARITY 1 and 2
is the percentage of participants who achieve three-lines or
greater improvement in BCDVA at near without losing one-line (5
letters or more of distance vision) at 3 hours post-treatment.
In both the vehicle-controlled CLARITY 2 trial and the
brimonidine-controlled CLARITY 1 trial, our lead product candidate
LNZ100 (1.75% aceclidine) achieved all primary and secondary near
vision improvement endpoints, including demonstrating (in all
cases, p<0.0001):
- Rapid onset: at 30 minutes, for CLARITY 2, 71% and 91%
of participants achieved three- and two-lines or greater
improvement, respectively, and for CLARITY 1, 72% and 87% of
participants achieved three- and two-lines or greater improvement,
respectively;
- At 3 hours (primary endpoint for three-lines): for
CLARITY 2, 71% and 91% of participants achieved three- and
two-lines or greater improvement, respectively, and for CLARITY 1,
64% and 83% of participants achieved three- and two-lines or
greater improvement, respectively; and
- Long duration: at 10 hours, for CLARITY 2, 40% and 69%
of participants achieved three- and two-lines or greater
improvement, respectively, and for CLARITY 1, 27% and 61% of
participants achieved three- and two-lines or greater improvement,
respectively.
Near vision improvement was reproducible and consistent across
both CLARITY 1 and 2 throughout the four-week study periods.
Additionally, in CLARITY 2, nearly all (95%) participants who
received LNZ100 achieved the clinically meaningful two-lines or
greater improvement (p<0.0001) at 1 hour post-treatment.
LNZ100 also demonstrated statistically significant (p<0.0001)
improvement of 2-4 letters on distance vision in normal light and
no negative impact to distance vision in low light at all time
points.
LNZ100 was well-tolerated with no treatment-related serious
adverse events observed in the over 30,000 treatment days across
all three CLARITY trials. The only reported adverse events with an
incidence at 5% or more were installation site irritation, visual
impairment and hyperemia which were 100% characterized by
participants as mild, and headaches which were characterized as
mild by 89% of participants. We believe these adverse events were
transient, consistent with those observed in previous trials.
On day 28 of the CLARITY 1 and 2 trials, 223 participants who
received LNZ100 were surveyed on their experience. 90% indicated
they noticed an improvement in their near vision and 75% said they
would want to continue to use these eye drops after the study, of
which 81% noted they expected to use them 4-7 days a week. We
believe these patient survey outcomes further confirm the potential
commercial opportunity for LNZ100.
Based on these results, LENZ Therapeutics anticipates submitting
a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for LNZ100 as a treatment for presbyopia
mid-2024.
Additional results from the CLARITY study will be presented at
future medical meetings.
Conference Call Information
The Company will host a conference call and webcast today,
Wednesday, April 3, 2024, at 8:00 a.m. ET to discuss the topline
results. The live webcast and materials from today’s conference
call can be accessed here and on the LENZ Therapeutics website at
www.LENZ-tx.com in the Investors & Media section or by calling
877-315-3033 or 215-268-9883. A replay of the webcast will be
archived and available for 30 days following the event.
About Presbyopia
Presbyopia is the inevitable loss of near vision associated with
aging and impacts the daily lives of nearly all people over 45. In
the United States, the estimated addressable population who suffer
from this condition, known as presbyopes, is 128 million, almost
four times the number of individuals suffering from dry eye disease
and three times the number of individuals suffering from childhood
myopia, macular degeneration, diabetic retinopathy, and glaucoma
combined.
About LENZ Therapeutics
LENZ Therapeutics is a late clinical-stage biopharmaceutical
company focused on developing the first aceclidine-based eye drop
to improve vision in patients diagnosed with presbyopia. LENZ’s
product candidate LNZ100 is a preservative-free, single-use,
once-daily eye drop containing aceclidine. The Phase 3 CLARITY
trials of LNZ100 were completed in March 2024 and NDA submission is
planned in mid-2024. LENZ is committed to commercializing a
potential best-in-class pharmaceutical presbyopia solution that
enhances vision for “all eyes, all day.” LENZ is headquartered in
San Diego, California. For more information, visit:
LENZ-tx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of federal securities laws. You can identify
forward-looking statements by words such as “may,” “will,” “could,”
“can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “poised,”
“continue,” “ongoing” or the negative of these terms or other
comparable terminology, but not all forward-looking statements will
contain these words. Forward-looking statements in this press
release include, but are not limited to, statements regarding the
potential of LNZ100 to have best-in-class performance; our plans
relating to the clinical development of our product candidates,
including statements regarding the timing, presentation and
reporting of data from our clinical trials and studies and the
timing of a potential NDA submission for LNZ100; the size of the
addressable population for our product candidates; our expectations
regarding the commercial opportunity and beneficial characteristics
of our product candidates; and our plans regarding
commercialization of LNZ100, if approved. These statements are
based on numerous assumptions concerning the development of LENZ’s
products and target markets and involve substantial risks,
uncertainties and other factors that may cause actual results,
levels of activity, performance or achievement to be materially
different from the information expressed or implied by these
forward-looking statements, including those risk factors described
in the final 424B3 proxy statement/prospectus filed with the SEC on
February 13, 2024. We cannot assure you that the forward-looking
statements in this press release or the assumptions upon which they
are based will prove to be accurate. The forward-looking statements
in this press release are as of the date of this press release.
Except as otherwise required by applicable law, LENZ disclaims any
duty to update any forward-looking statements. You should,
therefore, not rely on these forward-looking statements as
representing our views as of any date subsequent to the date of
this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240403843686/en/
Dan Chevallard LENZ Therapeutics IR@LENZ-Tx.com
Janhavi Mohite Stern Investor Relations, Inc.
janhavi.mohite@sternir.com
LENZ Therapeutics (NASDAQ:LENZ)
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