Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the
“Company”), a clinical-stage biopharmaceutical
company committed to developing novel, transformative therapies
for serious metabolic and rare diseases, today announced
positive topline results from the Phase 2 clinical study of RZ402
in patients with DME who are naïve to or have received limited
anti-vascular growth factor (anti-VEGF) injections.
“The results are monumental for the DME community,”
said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of
Ophthalmology at the Byers Eye Institute, and Professor of Medicine
and Professor of Pediatrics at the Stanford University School of
Medicine, and a member of Rezolute’s Scientific Advisory Board. “I
am impressed by the significant reduction in CST in this study
across all three dosages as retinal thickness is the key biomarker
to determine whether a therapy may offer a potential benefit to
patients. These data are very encouraging and are supportive of the
potential for a new first-line, non-invasive treatment for
DME.”
94 participants were enrolled in the U.S.
multi-center, randomized, double-masked, placebo-controlled,
parallel-arm study to evaluate the safety, efficacy, and
pharmacokinetics of RZ402 administered as a monotherapy over a
12-week (three month) treatment period.
“I am encouraged to see the initial results of this
proof-of-concept study and am enthusiastic about the possibility of
an oral therapy to treat DME,” said Arshad Khanani, MD, MA, FASRS,
Clinical Professor at the Reno School of Medicine, University of
Nevada, and Primary Investigator of the study. “Importantly, an
oral therapy would afford us the opportunity to address both eyes
and intervene much earlier, potentially altering the long-term
prognosis for individuals with DME.”
“We are very excited about these results and,
importantly, would like to thank the patients, the leading retina
specialists across the country, and their motivated staff who all
made this study possible,” said Raj Agrawal, MD, Vice President and
Head of Ophthalmological Clinical Development at Rezolute.
Study design and eligibility
criteria
- DME patients with mild to moderate
non-proliferative diabetic retinopathy (DR)
- Patients must have received no more
than three anti-VEGF injections previously (none within eight weeks
of randomization)
- CST of ≥320 microns in males and
≥305 microns in females
- Best Corrected Visual Acuity (BCVA)
of ≤78 letters on Early Treatment Diabetic Retinopathy Study
(ETDRS) assessment
- Eligible participants were
randomized equally, to one of three RZ402 active treatment arms at
doses of 50, 200, and 400 mg, or a placebo control arm, to receive
study drug once daily for 12 weeks, before completing a four-week
follow-up
RZ402 met both primary endpoints of
change in macular edema (CST) and a good safety
profile
- CST improved significantly at all
RZ402 dose levels compared to placebo (up to approximately 50
microns; p=0.02)
- Continued downward trajectory in
CST over course of study and at end of treatment
- No significant difference between
RZ402 dose levels, though response was largest at the 200 mg
dose
- Sub-analysis by DME severity (CST
≥400 microns) indicates an improvement of approximately 75 microns
at the 200 mg dose
- CST declined in most patients who
received the 200 mg dose of RZ402, including clinically
significant improvements from baseline in more than 20%
of participants, compared to none in placebo, with high rates
of worsening
- RZ402 was safe and well-tolerated
- Adverse events (AEs) were generally
mild and rates were comparable to placebo
- Three participants experienced
serious AEs which were all judged by the Investigator as unrelated
to study drug
- No ocular adverse effects that are
typically seen with intravitreal injections
- Electrocardiograms (ECGs), vitals,
and safety labs were unremarkable
- Target concentrations were exceeded
at all three dose levels and continue to support once daily oral
dosing
Secondary and additional
endpoints
- No significant improvements in BCVA
compared to placebo
- In-line with expectations for a
study of this duration
- Observed improvements in CST would
predict visual improvements in a longer duration study
- Five RZ402 treated participants at
200 mg (20 percent) experienced a 1-step improvement in Diabetic
Retinopathy Severity Score (DRSS) compared to one participant in
placebo
The Company plans to present these data and
further findings at an upcoming medical conference.
Virtual Investor EventThe
Company will host a virtual investor event to review these topline
results today at 5:30pm ET. The event will be webcast live and
a replay of the webcast will be archived in the Events section of
the Company’s investor relations website following the event.
Date: Tuesday, May
21st, 5:30pm
ETWebcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=6VUQj5bb
Dial-in:
- Toll Free: 1-877-270-2148
- International: 1-412-902-6510
About DME
DME is a severe, systemic, vision-threatening
complication of diabetic retinopathy (DR) characterized by swelling
of the retina and thickening of the macula, the part of the eye
that is responsible for high-resolution vision. Anti-VEGF
injections into the eye are the current standard of care for DME,
requiring continued administration over long periods of time to
preserve vision. Due to their invasive route of administration and
occasional serious side effects, there is a tendency to delay
treatment until later in the disease course, and long-term
compliance with eye injection regimens can be difficult for
patients. Coupled with inadequate responsiveness in some patients,
this leads to overall undertreatment and suboptimal vision outcomes
in DME patients. DME is a result of a systemic microvascular
complication of diabetes, manifesting in the retinal blood vessels
behind the eyes, and therefore commonly affects both eyes. With
currently available intravitreal anti-VEGF therapies, two separate
eye injections are required, or treatment of one eye or both eyes
may be deferred, when both eyes are affected.
About RZ402
RZ402 is an oral, small molecule, selective and
potent, plasma kallikrein inhibitor (PKI), for the chronic
treatment of DME. By inhibiting the activation of kallikrein, RZ402
is designed to block bradykinin production and its resulting
effects on vascular leakage and inflammation. Topline results from
the Phase 2 study of RZ402 in patients with DME demonstrated a
significant reduction in central subfield thickness (CST) in the
Study Eye at all RZ402 dose levels compared to placebo (up to
approximately 50 micron improvement) and was safe and
well-tolerated.
About Rezolute, Inc.
Rezolute strives to disrupt current treatment
paradigms by developing transformative therapies for devastating
rare and chronic metabolic diseases. Its novel therapies hold the
potential to significantly improve outcomes and to reduce the
treatment burden for patients, treating physicians and the
healthcare system. Rezolute is steadfast in its mission to create a
profound, positive and lasting impact on the lives of patients.
Patient, clinician and advocate voices are integrated in the
Company’s drug development process. Rezolute places an emphasis on
understanding the patient’s lived experiences, enabling the Company
to boldly address a range of severe conditions. For more
information, visit www.rezolutebio.com.
Forward-Looking Statements
This release, like many written and oral
communications presented by Rezolute and our authorized officers,
may contain certain forward-looking statements regarding our
prospective performance and strategies within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities
Exchange Act of 1934, as amended. We intend such forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995 and are including this statement for
purposes of said safe harbor provisions. Forward-looking
statements, which are based on certain assumptions and describe
future plans, strategies, and expectations of Rezolute, are
generally identified by use of words such as "anticipate,"
"believe," "estimate," "expect," "intend," "plan," "project,"
"prove," "potential," "seek," "strive," "try," or future or
conditional verbs such as "predict," "could," "may," "likely,"
"should," "will," "would," or similar expressions. These
forward-looking statements include, but are not limited to
statements regarding the RZ402 study, the ability of RZ402 to
become an effective treatment for diabetic macular edema, the
effectiveness or future effectiveness of RZ402 to become an
effective treatment for diabetic macular edema, and statements
regarding clinical trial timelines for RZ402. Our ability to
predict results or the actual effects of our plans or strategies is
inherently uncertain. Accordingly, actual results may differ
materially from anticipated results. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Except as required by
applicable law or regulation, Rezolute undertakes no obligation to
update these forward-looking statements to reflect events or
circumstances that occur after the date on which such statements
were made. Important factors that may cause such a difference
include any other factors discussed in our filings with the SEC,
including the Risk Factors contained in the Rezolute’s Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q, which are
available at the SEC’s website at www.sec.gov. You are urged to
consider these factors carefully in evaluating the forward-looking
statements in this release and are cautioned not to place undue
reliance on such forward-looking statements, which are qualified in
their entirety by this cautionary statement.
Contacts:
Rezolute, Inc.Christen
Baglaneascbaglaneas@rezolutebio.com508-272-6717
LHA Investor RelationsTirth T.
Pateltpatel@lhai.com212-201-6614
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