Rezolute, Inc. (Nasdaq: RZLT), a
clinical-stage biopharmaceutical company committed to
developing novel, transformative therapies for serious
metabolic and rare diseases, today announced the completion of
enrollment in its RZ402 Phase 2 study in diabetic macular edema
(“DME”). RZ402 is a selective and potent plasma kallikrein
inhibitor (“PKI”) being developed as a potential oral therapy for
the chronic treatment of DME.
The study is a multi-center, randomized,
double-masked, placebo-controlled, parallel-arm study to evaluate
the safety, efficacy, and pharmacokinetics of RZ402 administered as
a once daily oral monotherapy over a 12-week treatment period and
four-week follow-up in participants with DME who are naïve to, or
have received limited anti-VEGF injections. Eligible participants
were randomized equally to either a placebo control arm or one of
three RZ402 active treatment arms at doses of 50, 200, and 400
mg.
This proof-of-concept study was designed to
enroll up to 100 participants to evaluate activity and safety by
individual dose level and in pooled fashion. In the fourth quarter
2023, based on considerable momentum, the Company elected to keep
enrollment open into December to include as many eligible patients
as possible. Screening is now complete, and final study enrollment
is expected to be approximately 95 participants. Additionally,
although each participant has an assigned study eye, it is expected
that a meaningful number of non-study eyes will be eligible for
evaluation. Since DME results from a systemic vascular complication
associated with diabetes, it commonly affects both eyes. RZ402, as
an orally available systemic therapy, has the potential to treat
both eyes simultaneously. As a result of the extension of the
enrollment period, the Company now plans to report topline results
in the middle of the second quarter 2024, rather than the end of
the first quarter 2024.
“The strong commitment from our participating
clinical trial sites and equally strong conclusion of study
enrollment are indicative of the high demand and unmet medical need
for an oral therapy and new mechanistic target for the chronic
treatment of DME,” remarked Dr. Brian Roberts, Chief Medical
Officer of Rezolute. “We are incredibly excited and thankful for
the level of the engagement that we have received from the retina
community and wish to thank the study investigators, their study
staff, and the patient participants who trailblaze new therapies.
We very much look forward to reporting the results from this study
in the coming months.”
The principal endpoints of the trial include (i)
the change in central subfield thickness of the macula, as measured
by Spectral Domain Ocular Coherence Tomography, (ii) the change in
best-corrected visual acuity as measured by the early treatment
diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics
of RZ402 in patients with DME, and (iv) the safety and tolerability
of RZ402.
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. Although a single
study eye was identified for primary evaluation, Rezolute plans to
take advantage of the binocular exposure that is achieved with its
oral therapy and will also evaluate key endpoints in the non-study
eye.
About RZ402RZ402 is a selective
and potent PKI being developed as a potential once-daily oral
therapy 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.
RZ402 has been shown to reduce and prevent
retinal vascular leakage in animal models by up to 90%. Results
from a Phase 1b multiple ascending dose (MAD) study showed that
RZ402 was readily bioavailable with dose-dependent increases in
systemic exposures. RZ402 concentrations substantially exceeded
target efficacious concentrations based on a combination of
in-vitro and in-vivo pharmacology studies in animals, supporting
the potential as a once daily therapy for DME. RZ402 was generally
safe and well-tolerated, including at higher doses than previously
tested in the single ascending dose (SAD) study. There were no
serious adverse events, adverse drug reactions, or identified
risks.
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 both
significantly improve outcomes and reduce the treatment burden for
patients, treating physicians, and the healthcare system. Rezolute
is steadfast in its mission to create profound, positive, and
lasting impacts on patients’ lives. 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 StatementsThis
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," "seek," "strive," "try," or future or conditional verbs
such as "could," "may," "should," "will," "would," or similar
expressions.
These forward-looking statements include, but are
not limited to and statements regarding PRIME designation and the
designation’s meaning on the ability of RZ358 to become an
effective treatment to congenital HI, the effectiveness or future
effectiveness of RZ358 for the treatment of congenital HI, and
statements regarding clinical trial timelines for RZ358. 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.
Investors:Stephanie CarringtonICR
WestwickeRezoluteIR@westwicke.com(646) 277-1282
Media:media-relations@rezolutebio.com
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