Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage
biopharmaceutical company dedicated to developing transformative
therapies with the potential to disrupt current treatment paradigms
for devastating metabolic diseases, today provided an update on its
clinical development plans for RZ358, the Company’s product
candidate for congenital hyperinsulinism (congenital HI). Rezolute
plans to initiate sunRIZE, a pivotal Phase 3 clinical study of
RZ358, in Europe and other geographies outside the US in Q4 2023,
with topline results anticipated in the first half of 2025. The
sunRIZE study is a randomized, double-blind, placebo-controlled,
parallel arm evaluation of RZ358 in participants with congenital HI
who are not adequately responding to standard of care medical
therapies. The Phase 3 study follows the Company’s successful Phase
2b RIZE study which demonstrated that RZ358 was generally safe and
well-tolerated, as well as effective in improving hypoglycemia in
participants who were failing available medical therapies.
The Company has concluded its pre-Phase 3 regulatory and
scientific advice meetings with European health authorities and has
reached agreement on the sunRIZE study design, that will include
participants 3 months of age and older. In the US, the Company has
had similar interactions with the US Food and Drug Administration
(FDA) culminating in a meeting held with the agency on May 24,
2023, and FDA has maintained an existing age restriction of 12
years and older on RZ358 clinical studies and implemented dose
level restrictions for RZ358 based on historical rat toxicology
findings. The FDA restrictions make it infeasible to include the US
in the sunRIZE study at this time, particularly given that the
pediatric population with congenital HI has the greatest
therapeutic need. The Company is evaluating potential nonclinical
studies to address FDA’s concerns in parallel with the initiation
and advancement of sunRIZE outside of the US.
Nevan Charles Elam, Rezolute’s Founder and Chief Executive
Officer, stated, “We believe that RZ358 has tremendous potential to
fulfill a significant unmet need for patients and families living
with congenital HI around the world and we are delighted to have
alignment for sunRIZE with regulators outside of the US. We believe
that there may be a path forward to address FDA’s nonclinical
concerns and ensure that patients in the US have access to RZ358
should the therapy continue to demonstrate good safety and efficacy
and be eligible for regulatory approval.”
More information on sunRIZE and related regulatory interactions
can be found in a filing made today on Form 8-K filed with the US
Securities and Exchange Commission.
Conference Call InformationRezolute will host a
conference call today, June 27, 2023, at 4:30 p.m. EDT.
To access the conference call, dial 1-877-270-2148 from the U.S.
and Canada or 1-412-902-6510 internationally and ask to be joined
into the Rezolute call. The live audio webcast of the call will be
available under "Events" in the Investor section of the Company's
website
at https://ir.rezolutebio.com/news-events/ir-calendar.
About Congenital Hyperinsulinism (HI)Congenital
HI is the most common cause of recurrent and persistent
hypoglycemia in children. Patients with congenital HI typically
present with signs or symptoms of hypoglycemia within the first
month of life. These episodes can result in significant brain
injury and death if not recognized and managed appropriately.
Additionally, recurrent, or cumulative, hypoglycemia can lead to
progressive and irreversible damage over time, including serious
and devastating brain injury, seizures, neuro-developmental
problems, feeding difficulties, and significant impact on patient
and family quality of life. The two most-commonly used long-term
medications, diazoxide and somatostatin analogs, are not Food and
Drug Administration (FDA) approved for all forms of this condition
and often are ineffective or have intolerable side effects. In
cases of congenital HI that are unresponsive to medical management,
surgical removal of the pancreas may be required. In those with
diffuse congenital HI where the whole pancreas is affected, a
near-total pancreatectomy can be undertaken, although about half of
these children will continue to have hypoglycemia and require
medical treatment for congenital HI.
About RZ358RZ358 is a human monoclonal antibody
that binds to a unique allosteric site on insulin receptors in the
liver, fat, and muscle. The antibody counteracts the effects of
elevated insulin in the body by modifying insulin's binding,
signaling, and activity to maintain glucose levels in a normal
range. Rezolute believes that RZ358 is ideally suited as a
potential therapy for congenital hyperinsulinism (HI) and other
conditions characterized by excessive insulin levels. As RZ358 acts
downstream from the beta cells, it has the potential to be
universally effective at treating congenital HI, regardless of the
causative genetic defect. RZ358 received Orphan Drug Designation in
the United States and European Union as well as Pediatric Rare
Disease Designation in the US.
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, the treating
physician, and the healthcare system. Patient, clinician, and
advocate voices are integrated in the Company’s drug development
process, enabling Rezolute to boldly address a range of severe
conditions. Rezolute is steadfast in its mission to create
profound, positive, and lasting impact on patients’ lives. The
Company’s lead clinical asset, RZ358, is in late-stage development
for the treatment of congenital hyperinsulinism, a rare pediatric
endocrine disorder. Rezolute is also developing RZ402, an orally
available plasma kallikrein inhibitor, for the treatment of
diabetic macular edema. For more information,
visit www.rezolutebio.com or follow us on Twitter.
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, statements regarding future events and results,
clinical study plans and the locations of such clinical studies,
the timing of the release of Phase 3 clinical study results, our
ability to address FDA’s concerns through additional nonclinical
studies, our ability to conduct the Phase 3 study in Europe and
throughout the world, the effectiveness or future effectiveness of
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 Rezolute’s
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.
Investor:Kimberly Minarovich, Argot
Partnersrezolute@argotpartners.com212-600-1902
Media:Jennifer Arcure, Canale Communications,
Inc.jennifer.arcure@evokegroup.com917-603-0681
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