Rege Nephro Acquires Tamibarotene-Related Assets from Syros Pharmaceuticals for U.S. Clinical Trials
Rege Nephro has acquired Tamibarotene-related clinical and non-clinical assets from Syros Pharmaceuticals (NASDAQ:SYRS) on February 26, 2025. The acquisition includes clinical and non-clinical data, human safety study for NDA, CMO contracts, and Tamibarotene API and drug products.
Tamibarotene (RN-014), a retinoic acid receptor agonist, is currently in Phase 2 clinical trials in Japan for autosomal dominant polycystic kidney disease (ADPKD). Rege Nephro plans to initiate U.S. clinical trials after confirming efficacy and safety in Japan. Previously, Syros conducted Phase 3 trials of Tamibarotene for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
Rege Nephro ha acquisito il portafoglio clinico e non clinico relativo a Tamibarotene da Syros Pharmaceuticals (NASDAQ:SYRS) il 26 febbraio 2025. L'acquisizione comprende dati clinici e non clinici, uno studio sulla sicurezza umana per la NDA, contratti con CMO, oltre all'API e ai prodotti farmaceutici di Tamibarotene.
Tamibarotene (RN-014), un agonista del recettore dell'acido retinoico, è attualmente in fase 2 di sperimentazione clinica in Giappone per la malattia policistica renale autosomica dominante (ADPKD). Rege Nephro prevede di avviare trial clinici negli Stati Uniti dopo aver confermato efficacia e sicurezza in Giappone. In precedenza, Syros aveva condotto studi di fase 3 su Tamibarotene per la sindrome mielodisplastica (MDS) e la leucemia mieloide acuta (AML).
Rege Nephro adquirió los activos clínicos y no clínicos relacionados con Tamibarotene de Syros Pharmaceuticals (NASDAQ:SYRS) el 26 de febrero de 2025. La adquisición incluye datos clínicos y no clínicos, un estudio de seguridad humana para la NDA, contratos con CMO, así como el API y los productos farmacéuticos de Tamibarotene.
Tamibarotene (RN-014), un agonista del receptor de ácido retinoico, se encuentra actualmente en ensayos clínicos de fase 2 en Japón para la enfermedad poliquística renal autosómica dominante (ADPKD). Rege Nephro planea iniciar ensayos clínicos en EE. UU. tras confirmar la eficacia y seguridad en Japón. Anteriormente, Syros llevó a cabo ensayos de fase 3 de Tamibarotene para el síndrome mielodisplásico (MDS) y la leucemia mieloide aguda (AML).
Rege Nephro는 2025년 2월 26일 Syros Pharmaceuticals (NASDAQ:SYRS)로부터 타미바로틴 관련 임상 및 비임상 자산을 인수했습니다. 이번 인수에는 임상 및 비임상 데이터, NDA용 인체 안전성 연구, CMO 계약, 타미바로틴 API 및 의약품이 포함됩니다.
타미바로틴(RN-014)은 레티노산 수용체 작용제로, 현재 일본에서 상염색체 우성 다낭성 신장 질환(ADPKD)을 대상으로 2상 임상시험이 진행 중입니다. Rege Nephro는 일본에서 효능과 안전성이 확인된 후 미국에서 임상시험을 시작할 계획입니다. 이전에 Syros는 골수형성이상증후군(MDS)과 급성 골수성 백혈병(AML)에 대해 3상 임상시험을 수행했습니다.
Rege Nephro a acquis les actifs cliniques et non cliniques liés au Tamibarotène auprès de Syros Pharmaceuticals (NASDAQ:SYRS) le 26 février 2025. Cette acquisition comprend des données cliniques et non cliniques, une étude de sécurité humaine pour la NDA, des contrats avec des CMO, ainsi que l'API et les produits médicamenteux de Tamibarotène.
Le Tamibarotène (RN-014), un agoniste du récepteur de l'acide rétinoïque, est actuellement en essais cliniques de phase 2 au Japon pour la maladie polykystique autosomique dominante du rein (ADPKD). Rege Nephro prévoit de lancer des essais cliniques aux États-Unis après avoir confirmé l'efficacité et la sécurité au Japon. Auparavant, Syros avait mené des essais de phase 3 du Tamibarotène pour le syndrome myélodysplasique (SMD) et la leucémie myéloïde aiguë (LMA).
Rege Nephro hat am 26. Februar 2025 klinische und nicht-klinische Vermögenswerte im Zusammenhang mit Tamibaroten von Syros Pharmaceuticals (NASDAQ:SYRS) erworben. Die Übernahme umfasst klinische und nicht-klinische Daten, eine Human-Sicherheitsstudie für die NDA, CMO-Verträge sowie Tamibaroten-API und Arzneimittelprodukte.
Tamibaroten (RN-014), ein Agonist des Retinsäurerezeptors, befindet sich derzeit in Phase-2-Studien in Japan zur Behandlung der autosomal-dominanten polyzystischen Nierenerkrankung (ADPKD). Rege Nephro plant, nach Bestätigung von Wirksamkeit und Sicherheit in Japan klinische Studien in den USA zu starten. Zuvor führte Syros Phase-3-Studien von Tamibaroten bei myelodysplastischem Syndrom (MDS) und akuter myeloischer Leukämie (AML) durch.
- Asset acquisition includes valuable clinical data and manufacturing infrastructure
- Expansion of development capabilities into U.S. market
- Streamlined pathway for U.S. clinical trials through acquired safety data
- Efficacy and safety confirmation in Japanese trials required before U.S. expansion
- Additional clinical trials needed for U.S. market entry
Tamibarotene (RN-014) is a retinoic acid receptor agonist for which Rege Nephro is currently conducting a Phase 2 clinical trial in
This acquisition, encompassing their clinical and non-clinical data including human safety study for New Drug Application (NDA), contracts with a contract manufacturing organization (CMO), and Tamibarotene active pharmaceutical ingredient (API) and drug products, is expected to enhance Rege Nephro's capabilities and streamline operations for its clinical trial operations in
About Rege Nephro:
Rege Nephro, founded in 2019, is a clinical-stage biotech company leveraging technology based on research of Prof. Kenji Osafune, deputy director of the Center for iPS Cell Research and Application (CiRA),
About RN-014:
RN-014 is a therapeutic candidate for autosomal dominant polycystic kidney disease (ADPKD). It is a retinoic acid receptor (RAR) agonist expected to suppress cyst formation and improve renal function. Rege Nephro initiated a Phase 2 clinical trial in December 2023, and enrollment for the second stage has now been completed. To date, no significant safety concerns have arisen and preliminary efficacy has been demonstrated.
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SOURCE Rege Nephro Co., Ltd.
FAQ
What assets did Rege Nephro acquire from Syros Pharmaceuticals (SYRS) in February 2025?
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