Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism
17 Outubro 2023 - 9:00AM
Rezolute, Inc. (Nasdaq: RZLT), a
clinical-stage biopharmaceutical company committed to
developing novel, transformative therapies for serious
metabolic and rare diseases, today announced that the European
Medicines Agency (EMA) has granted Priority Medicines (PRIME)
eligibility to RZ358 for the treatment of congenital
hyperinsulinism (HI).
PRIME eligibility is granted by EMA to drug
candidates that target an unmet medical need and show potential
benefit for patients based on clinical trial results. The PRIME
initiative was created to provide proactive and enhanced support to
developers of promising medicines to optimize development plans and
accelerate evaluation with the goal of having new therapies reach
patients faster. With respect to congenital HI, EMA has stated that
there is an unmet medical need with no specifically authorized
therapeutics available for the condition and that there are
significant short-term and long-term risks, which are consequences
of severe hypoglycemia.
“We are excited to receive PRIME eligibility for
RZ358, especially as we plan to initiate our Phase 3 study for
RZ358 this quarter,” remarked Susan Stewart, JD, Chief Regulatory
Officer at Rezolute. “We are appreciative that the EMA recognizes
the devastating nature of the disease and the potential for
RZ358 to have a significant positive impact on clinical outcomes
for patients and their families.”
PRIME eligibility was granted based on data from
the RIZE study in congenital HI, which safely demonstrated
significant improvements in hypoglycemia events and time, with
average improvements of approximately 75% at the intended Phase 3
doses. Glucose improvements were independent of age, with a similar
magnitude in the patient age groups of 2-6 years old, 6-12 years
old, and > 12 years old.
About Congenital 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. 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 fully
human monoclonal antibody that works downstream from the pancreas
and instead 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 modulating insulin's binding,
signaling, and activity to restore glucose levels to a normal
range. Rezolute believes that RZ358 is ideally suited as a
potential therapy for congenital HI and other conditions
characterized by excessive insulin levels. Because RZ358 acts
downstream from the pancreas, it has the potential to be
universally effective at treating congenital HI, regardless of the
causative genetic defect, as well as acquired forms of HI such as
those mediated by insulinomas and other tumor types. RZ358 received
Orphan Drug Designation in the United States and European Union for
the treatment of congenital HI, 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, 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. In addition to RZ358 for the treatment of
congenital HI, 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.
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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