FDA Lifts Partial Clinical Holds on RZ358 for the Treatment of Congenital Hyperinsulinism and Authorizes U.S. Inclusion in Ongoing Phase 3 Study
September 09 2024 - 7:30AM
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a
late-stage rare disease company developing a novel therapy to
treat hyperinsulinism (HI), today announced that the U.S. Food and
Drug Administration (FDA) has removed the partial clinical holds on
RZ358 (ersodetug), a potential treatment for hypoglycemia caused by
congenital HI.
Ersodetug is currently being studied in sunRIZE,
a global Phase 3, multi-center, double-blind, randomized,
placebo-controlled, safety and efficacy registrational study in
participants with congenital HI. The Company will now commence
study start-up activities in the U.S. with the goal of including
U.S. participants in the global sunRIZE study. The Company
anticipates potential U.S. enrollment to begin in early 2025, which
will enable announcement of topline data from the study in the
second half of 2025.
“We are delighted that FDA has completely
removed the partial clinical holds and are allowing us to proceed
in the U.S. at all doses and in participants as young as three
months of age as part of our ongoing global study. Of note, FDA
specifically concluded that the liver toxicity observed in Sprague
Dawley rats is likely strain-specific and not otherwise relevant to
humans,” said Nevan Charles Elam, Chief Executive Officer and
Founder of Rezolute. “Coming on the heels of our recent
announcement of FDA clearance of a separate Phase 3 study in
tumor-associated HI, we are in the unique and fortunate position to
be advancing ersodetug in two Phase 3 rare disease programs in the
U.S. and globally.”
For more information on ersodetug and our
programs in congenital HI and tumor HI, please visit
https://www.rezolutebio.com/pipeline/.
About Ersodetug
Ersodetug is a fully human monoclonal antibody
that binds to a unique allosteric site on insulin receptors to
counteract the effects of insulin receptor over-activation by
insulin and related substances (such as IGF-2), thereby improving
hypoglycemia in the setting of hyperinsulinism. Because ersodetug
acts downstream from the pancreas, it has the potential to be
universally effective at treating hypoglycemia due to any form of
HI.
About sunRIZE
The Phase 3 sunRIZE study is a multi-center,
randomized, double-blind, placebo-controlled, parallel arm study
designed to evaluate the efficacy and safety of ersodetug in
patients with congenital HI who are experiencing poorly controlled
hypoglycemia. Participants between the ages of 3 months to 45 years
old are eligible to participate. The study is enrolling up to 56
participants in more than a dozen countries around the world.
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 RZ358 as a sunRIZE Phase 3
study, the Phase 2 RIZE study, the complete removal of the partial
clinical holds on RZ358 (ersodetug) for the treatment of
hypoglycemia, the ability of RZ358 to become an effective treatment
for congenital hyperinsulinism, the effectiveness or future
effectiveness of RZ358 to become an effective treatment for
congenital hyperinsulinism, and statements regarding the timeliness
of the ongoing global Phase 3 sunRIZE study. 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, and other factors discussed in the “Risk Factors”
section contained in 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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