Rezolute Announces Presentation of Participant Baseline Data from its Fully Enrolled Phase 3 Study of Ersodetug in Congenital Hyperinsulinism at the Upcoming Annual Meeting of the Endocrine Society (ENDO 2025)
Rezolute (NASDAQ:RZLT), a late-stage rare disease company, will present baseline data from its fully enrolled Phase 3 sunRIZE study of ersodetug for congenital hyperinsulinism at ENDO 2025. The presentation, scheduled for July 14, 2025, will focus on patient demographics and characteristics from the trial.
The company's Chief Medical Officer highlighted that the presentation will provide insights into the study population and its comparability to the Phase 2 RIZE study. With enrollment complete, topline data is expected in December 2025, marking progress toward a potential new treatment option for patients with limited alternatives.
Rezolute (NASDAQ:RZLT), un'azienda specializzata in malattie rare in fase avanzata, presenterà i dati di base del suo studio di Fase 3 sunRIZE, completamente arruolato, su ersodetug per l'iperinsulinemia congenita durante ENDO 2025. La presentazione, prevista per il 14 luglio 2025, si concentrerà sulle caratteristiche e i dati demografici dei pazienti coinvolti nello studio.
Il Direttore Medico dell'azienda ha sottolineato che la presentazione offrirà approfondimenti sulla popolazione dello studio e sulla sua comparabilità con lo studio di Fase 2 RIZE. Con il completamento dell'arruolamento, si prevede di ottenere i dati principali entro dicembre 2025, segnando un progresso verso una possibile nuova opzione terapeutica per pazienti con poche alternative disponibili.
Rezolute (NASDAQ:RZLT), una empresa en etapa avanzada dedicada a enfermedades raras, presentará los datos iniciales de su estudio de Fase 3 sunRIZE completamente reclutado sobre ersodetug para hiperinsulinismo congénito en ENDO 2025. La presentación, programada para el 14 de julio de 2025, se centrará en las características demográficas y clínicas de los pacientes del ensayo.
El Director Médico de la compañía destacó que la presentación proporcionará información sobre la población del estudio y su comparabilidad con el estudio de Fase 2 RIZE. Con el reclutamiento finalizado, se esperan los datos principales en diciembre de 2025, marcando un avance hacia una posible nueva opción de tratamiento para pacientes con alternativas limitadas.
Rezolute (NASDAQ:RZLT)는 후기 단계 희귀 질환 회사로서, 선천성 고인슐린혈증 치료제 ersodetug에 대한 완전 등록된 3상 sunRIZE 연구의 기초 데이터를 ENDO 2025에서 발표할 예정입니다. 발표는 2025년 7월 14일로 예정되어 있으며, 임상시험에 참여한 환자들의 인구통계학적 특성과 특성에 중점을 둘 것입니다.
회사의 최고 의료 책임자는 이번 발표가 연구 대상자 집단과 2상 RIZE 연구와의 비교 가능성에 대한 통찰을 제공할 것이라고 강조했습니다. 등록이 완료됨에 따라, 주요 데이터는 2025년 12월에 발표될 예정이며, 이는 제한된 치료 옵션을 가진 환자들에게 새로운 치료 가능성을 향한 진전을 의미합니다.
Rezolute (NASDAQ:RZLT), une entreprise en phase avancée spécialisée dans les maladies rares, présentera les données de base de son étude de phase 3 sunRIZE entièrement recrutée sur ersodetug pour l'hyperinsulinisme congénital lors de l'ENDO 2025. La présentation, prévue pour le 14 juillet 2025, portera sur les caractéristiques démographiques et cliniques des patients de l'essai.
Le directeur médical de la société a souligné que cette présentation offrira des informations sur la population étudiée et sa comparabilité avec l'étude de phase 2 RIZE. Avec le recrutement terminé, les données principales sont attendues en décembre 2025, marquant une avancée vers une nouvelle option de traitement potentielle pour les patients disposant de peu d'alternatives.
Rezolute (NASDAQ:RZLT), ein Unternehmen in der späten Entwicklungsphase für seltene Krankheiten, wird Baseline-Daten aus seiner vollständig eingeschriebenen Phase-3-Studie sunRIZE zu ersodetug bei kongenitalem Hyperinsulinismus auf der ENDO 2025 vorstellen. Die Präsentation, geplant für den 14. Juli 2025, wird sich auf die demografischen Merkmale und Charakteristika der Patienten aus der Studie konzentrieren.
Der Chief Medical Officer des Unternehmens betonte, dass die Präsentation Einblicke in die Studienpopulation und deren Vergleichbarkeit mit der Phase-2-RIZE-Studie geben wird. Nach Abschluss der Einschreibung werden Topline-Daten für Dezember 2025 erwartet, was einen Fortschritt in Richtung einer potenziellen neuen Behandlungsoption für Patienten mit begrenzten Alternativen darstellt.
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REDWOOD CITY, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that the abstract titled “Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress” has been selected for a late-breaking presentation at ENDO 2025 taking place July 12-15, 2025 in San Francisco, CA, USA.
“We are excited to share baseline data from the sunRIZE study, which will offer important insights into this population and its comparability to the Phase 2 RIZE study, further highlighting the persistent unmet medical need,” said Brian Roberts, M.D., Chief Medical Officer at Rezolute. “With enrollment now complete and topline data expected in December, we are one step closer to potentially delivering a much-needed therapy to patients who currently have limited options.”
Presentation details are as follows:
Title: Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress
Format: Poster presentation
Session: Pediatric and Adolescent Endocrinology
Presentation Number: MON-213
Date/Time: Monday, July 14, 2025, 12:00 – 01:30 PM Pacific time
Presenters: Gopal Saha, MBBS and Brian Roberts, MD
About sunRIZE
The Phase 3 sunRIZE study (RZ358-301) 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 hyperinsulinism (HI), ages 3 months to 45 years old, who are experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants are randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug is administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants may roll-over into an optional open-label extension phase to continue to receive ersodetug, which has had a high rate of continuation thus far.
The study was to enroll approximately 56 participants in more than a dozen countries around the world, inclusive of U.S. patients, which has been completed and exceeded. The primary and key secondary efficacy endpoints in the study are the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment.
About Ersodetug
Ersodetug is a fully human IgG2 monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.
About Congenital Hyperinsulinism
Congenital Hyperinsulinism (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. More than half of children with congenital HI require long-term medical treatment for hypoglycemia that is not addressed by available therapies.
About Rezolute, Inc.
Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (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 both congenital and tumor HI. 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 data presented at ENDO 2025 and subsequent conferences, potential efficacy of ersodetug in the congenital HI patient population, the timeline for achieving results in the Phase 3 study and the potential approval and commercialization of ersodetug. 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.
Contacts:
Rezolute, Inc.
Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717
Media
Sarah Lima
Sarah@galvinPR.com
(774) 766-0200
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