Rezolute Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism
2024年8月5日 - 8:30PM
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a
late-stage biopharmaceutical company committed to developing
novel, transformative therapies for serious rare diseases, today
announced that it received U.S. Food and Drug Administration (FDA)
clearance for its Investigational New Drug (IND) application for
RZ358 (ersodetug) to treat hypoglycemia in patients with tumor
hyperinsulinism (HI). The Company is initiating start-up activities
for the study which will be primarily conducted in the U.S. and
patient enrollment is planned to commence in the first half of
2025. Ersodetug is also being studied in an ongoing global,
pivotal, Phase 3 clinical trial in patients with congenital HI.
Topline data from that study is expected in mid-2025.
“Hypoglycemia associated with tumor HI requires
treatment to prevent serious adverse outcomes and to improve
patients’ daily function and quality of life, including enabling
them to receive tumor directed therapies,” said Brian Roberts,
M.D., Chief Medical Officer at Rezolute. “We are encouraged by the
substantial real-world benefit we’ve witnessed in tumor HI patients
who have previously received ersodetug in our Expanded Access
Program, coupled with the safety and efficacy demonstrated in
clinical studies in patients with congenital HI, a similar
condition. We believe that the clearance of our IND for this Phase
3 study reflects FDA’s recognition of the potential for ersodetug
to address this serious unmet need and we are excited to be moving
one step closer to a potential universal treatment for hypoglycemia
caused by all forms of HI.”
The Phase 3 registrational study is a
double-blind, randomized, placebo-controlled trial of 24
participants who have inadequately controlled hypoglycemia because
of tumor HI. Eligible participants will be randomized in 1:1
fashion (12 per treatment arm) to receive ersodetug 9 mg/kg per
week or matched placebo, as an add-on to standard of care. Up to 24
additional participants may be enrolled into an open-label arm, in
participants whose hypoglycemia is being managed by IV glucose in a
hospital setting. Following a 6-week pivotal treatment period, all
participants may receive ersodetug in open-label extension. The
primary endpoint is the change in Level 2 (moderate) and Level 3
(severe) hypoglycemia events by self-monitored blood glucose.
Additional endpoints include overall hypoglycemia events, time in
hypoglycemia by continuous glucose monitor, patient reported
quality of life, hospitalizations, and change in glucose
requirements (for open-label hospitalized participants).
Ersodetug is a fully human monoclonal antibody
that binds to an allosteric site on the insulin receptor at target
tissues such as liver, fat and muscle. Ersodetug counteracts excess
insulin receptor activation caused by insulin and related hormones
thereby correcting hypoglycemia. Ersodetug has the potential to be
universally effective at treating hypoglycemia caused by any form
of HI, including congenital or acquired forms.
About Tumor Hyperinsulinism
(HI)
Tumor HI is a rare disease that may be caused by
two distinct types of tumors: islet cell tumors (ICTs) and
non-islet cell tumors (NICTs), both of which lead to hypoglycemia
as a result of excessive activation of the insulin receptor.
Insulinomas are the most common type of ICT and may cause
hypoglycemia by stimulating the over production of insulin. A
variety of different NICTs, particularly hepatocellular carcinoma,
can cause hypoglycemia by producing and secreting insulin-like
paraneoplastic substances such as IGF-2 that bind to and activate
the insulin receptor. With high morbidity and mortality rates
within tumor HI, there remains a significant unmet need for new
therapies directed at hypoglycemia treatment. Ersodetug has shown
real-world benefit in patients with insulinoma and preclinical
studies have shown that ersodetug can similarly blunt IGF-2 and
insulin-mediated insulin-receptor signaling.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company
focused on significantly improving outcomes for individuals with
hypoglycemia caused by HI. The Company’s antibody therapy,
ersodetug, is designed to treat all forms of HI and has shown
substantial benefit in clinical trials and real-world use for the
treatment of congenital HI and tumor HI.
Forward-Looking Statements
Any statements in this press release about the
Company’s future expectations, plans and prospects, including
statements regarding the public offering, constitute
forward-looking statements for purposes of the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. Forward-looking statements include any statements about the
Company’s strategy, future operations and future expectations and
plans and prospects for the Company, and any other statements
containing the words “anticipate,” “believe,” “estimate,” “expect,”
“intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions. These forward-looking
statements include statements about the RZ358 Expanded Access
Program, the Investigational New Drug (IND) application for RZ358,
the ability of the U.S. Ersodetug to become an effective treatment
for congenital hyperinsulinism, the effectiveness or future
effectiveness of the U.S. Ersodetug to become an effective
treatment for congenital hyperinsulinism, and statements regarding
clinical trial timelines for RZ358. These forward-looking
statements are based on information currently available to the
Company and its current plans or expectations, and are subject to a
number of uncertainties and risks that could significantly affect
current plans. Such forward-looking statements involve substantial
risks and uncertainties that could cause the Company’s development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, those related to market and other financial
conditions, the potential completion of the public offering,
satisfaction of customary closing conditions related to the public
offering and other factors discussed in the “Risk Factors” section
contained in the preliminary prospectus supplement and the reports
that the Company files with the SEC. Any forward-looking statements
represent the Company’s views only as of the date of this press
release. The Company anticipates that subsequent events and
developments will cause its views to change. While the Company may
elect to update these forward-looking statements at some point in
the future, the Company specifically disclaims any obligation to do
so except as required by law.
Contacts:
Rezolute, Inc.Christen
Baglaneascbaglaneas@rezolutebio.com508-272-6717
LHA Investor RelationsTirth T.
Pateltpatel@lhai.com212-201-6614
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