Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
January 23 2024 - 8:00AM
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 U.K.
Medicines and Healthcare products Regulatory Agency (MHRA) has
awarded the innovative medicine designation, the Innovation
Passport, to RZ358 for the treatment of hypoglycemia due to
congenital hyperinsulinism (HI). The Innovation Passport
designation was granted based on the substantial unmet medical need
in this condition and the potential for RZ358 to benefit patients
as evidenced by the Phase 2 RIZE study in congenital HI, which
safely demonstrated significant improvements in hypoglycemia
events.
The Innovation Passport designation in the U.K.
is the entry point to the Innovative Licensing and Access Pathway
(ILAP). The goal of ILAP is to accelerate the time to market and
facilitate patient access to medicines. The Innovation Passport is
the first step in the ILAP process, which activates the Medicines
and Healthcare products Regulatory Agency (MHRA) and its partner
agencies, including the National Institute for Health and Care
Excellence (NICE), and the Scottish Medicines Consortium (SMC).
“Congenital hyperinsulinism is the most frequent
cause of severe, persistent hypoglycemia in newborn babies, infants
and children,” said Susan Stewart, J.D., Chief Regulatory Officer
at Rezolute. “The Innovation Passport opens the door for Rezolute
to discuss access considerations for potential future indications
for RZ358. We are thrilled to receive this designation and work
closely with the U.K. and other regulatory authorities to bring
this meaningful therapy to patients in need.”
About Congenital
HyperinsulinismCongenital hyperinsulinism (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 excess insulin binding and activity, thereby improving
hypoglycemia. Rezolute believes that RZ358 is ideally suited as a
potential therapy for congenital HI and other conditions
characterized by excessive insulin activity (hyperinsulinism).
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 U.S. In the Phase 2 RIZE
study, participants with congenital HI ages 2 and older nearly
universally achieved significant improvements in hypoglycemia
across multiple endpoints, including the primary and key secondary
endpoints planned for the sunRIZE study. At doses and exposures
that are planned for the Phase 3 study, RZ358 was generally safe
and well-tolerated, and resulted in median improvements in
hypoglycemia exceeding 80%. Based on the RIZE clinical trial
outcomes and the evidence of benefit in this serious condition with
substantial unmet medical need, RZ358 was subsequently granted a
priority medicines (PRIME) designation by the European Medicines
Agency (EMA) and an Innovation Passport designation by the U.K.
Innovative Licensing and Access Pathway (ILAP) Steering Group for
the treatment of congenital HI.
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 statements regarding the Innovation Passport
designation, the PRIME designation and the meaning of the
designations on the ability of RZ358 to become an effective
treatment for congenital hyperinsulinism, the effectiveness or
future effectiveness of RZ358 for the treatment of congenital
hyperinsulinism, 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 & Media:Christen
BaglaneasRezolute, Inc.cbaglaneas@rezolutebio.com (508)272-6717
Investors:Stephanie CarringtonICR
WestwickeRezoluteIR@westwicke.com (646)277-1282
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