Rezolute Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH)
06 Marzo 2024 - 6:30AM
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 results from a
preclinical pharmacology study that validate the potential for its
lead clinical compound, RZ358, to treat individuals with non-islet
cell tumors (NICTs) that have uncontrolled hypoglycemia.
Tumor hyperinsulinism (HI) may be caused by a
variety of different tumor types, resulting in islet cell tumor
hypoglycemia (ICTH) and NICTH. The Company previously reported on
the successful use of RZ358 under its Expanded Access Program (EAP)
to treat patients with insulin-producing pancreatic islet cell
tumors (ICTs), or insulinomas, causing severe and uncontrolled
hypoglycemia. The therapeutic potential of RZ358 in this setting
was anticipated given that ICTH is mediated by insulin and that
RZ358 is known to work at the insulin receptor to decrease excess
insulin binding and activity. However, it was unknown if RZ358
would have utility in NICTH where hyperinsulinism is mediated by
hormones such as insulin-like growth factor-2 (IGF-2) or its
variants, which likewise cause hypoglycemia by binding to and
activating the insulin receptor. To test this, the Company recently
completed in vitro pharmacology studies to evaluate the impact of
clinically relevant concentrations of RZ358 on insulin receptor
activation by IGF-2, compared to insulin. This was tested at the
relative concentrations of each ligand that activate the insulin
receptor and are physiologically relevant in tumor HI caused
by ICTH and NICTH, respectively. These experiments successfully
demonstrated the ability of RZ358 to similarly blunt both IGF-2 and
insulin-mediated insulin-receptor signaling, at levels of these
ligands that are disease-relevant in humans.
“These data demonstrate proof of the
ligand-agnostic mechanism of action of RZ358 and therefore validate
its broad utility in treating hypoglycemia resulting from any form
of hyperinsulinism, including expanded tumor indications,” said Dr.
Brian Roberts, Chief Medical Officer of Rezolute. “Coupled with
known outcomes from our clinical trials in congenital HI and the
positive outcomes seen with ICTH in our expanded access program, we
are excited by the potential for RZ358 to provide dramatic
therapeutic benefit to cancer patients who often have limited
treatment options for managing serious and uncontrolled
hypoglycemia, which can accompany their cancer and disrupt
treatment plans.”
The Company recently reported on its successful
interaction with the U.S. Food and Drug Administration (FDA) in
January 2024 regarding the potential to initiate a single
registrational study in patients with hypoglycemia due to tumor HI.
The Company will continue to evaluate the feasibility of a
development program in this indication, with the possibility of
including both ICTH and NICTH patients. The inclusion of NICTH
patients in a potential addressable market for RZ358 in tumor HI
would more than double the population. The Company is also
currently evaluating RZ358 in a Phase 3 clinical trial in
congenital HI, which is a rare pediatric condition where, similar
to ICTH, children overproduce insulin creating a dangerous
hypoglycemic state.
About Tumor Hyperinsulinism
(HI)Tumor HI may be the result of two distinct types of
tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs),
both of which lead to hypoglycemia due to excessive activation of
the insulin receptor. Insulinomas are the most common type of
functional ICT and cause hypoglycemia because of over production of
insulin. NICTs can cause hypoglycemia by producing and secreting
insulin-like paraneoplastic substances such as IGF-2 or related
variants that bind to and activate the insulin receptor. This form
of hypoglycemia can occur in more than 15 different tumor types, 60
percent of which are malignant, including hepatocellular carcinoma.
The total addressable market for the combined indications causing
tumor HI is estimated to be approximately 4,500 patients in the
U.S. alone, including approximately 1,500 with ICTH and 3,000 with
NICTH. The unique mechanism of action of RZ358 to attenuate excess
insulin receptor activation mediated by insulin and related
substances makes the therapy a potential universal treatment for
hypoglycemia resulting from any form of hyperinsulinism.
About RZ358RZ358 is a fully human monoclonal
antibody that works downstream from the pancreas and other sources
of insulin or related paraneoplastic substances, and instead binds
to a unique allosteric site on insulin receptors in the liver, fat,
and muscle. The antibody counteracts excess insulin receptor
activation by insulin and other effector substances (such as
IGF-2), thereby improving hypoglycemia. Because RZ358 acts
downstream from the pancreas at the insulin receptor, it has the
potential to be universally effective at treating hypoglycemia due
to congenital HI, regardless of the causative genetic defect, as
well as acquired forms of HI such as those mediated by insulinomas
(ICTs) and other tumor types (NICTs). RZ358 received Orphan Drug
Designation in the United States and European Union for the
treatment of congenital HI, as well as Orphan Drug Designation and
Pediatric Rare Disease Designation in the U.S. In the Phase 2 RIZE
study, participants with congenital HI ages two 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. RZ358 also received Orphan Drug
Designation status in the European Union for the treatment of
Insulinoma, the primary cause of ICTH.
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 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,"
"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 RZ358
Expanded Access Program, 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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/165f8dbc-1fce-47b8-ac3f-0cf6fb4170cb
Rezolute (NASDAQ:RZLT)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Rezolute (NASDAQ:RZLT)
Gráfica de Acción Histórica
De May 2023 a May 2024