Rege Nephro Acquires Tamibarotene-Related Assets from Syros Pharmaceuticals for U.S. Clinical Trials

Rhea-AI Summary

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).

Positive

• 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

Negative

• Efficacy and safety confirmation in Japanese trials required before U.S. expansion
• Additional clinical trials needed for U.S. market entry

KYOTO, Japan, April 15, 2025 /PRNewswire/ -- Rege Nephro Co., Ltd. (Headquarter: Kyoto, Japan; Chief Executive Officer: Akifumi Morinaka) has announced that it has successfully acquired Tamibarotene-related clinical and non-clinical assets from Syros Pharmaceuticals, Inc. (Headquarters: Boston, MA; NASDAQ:SYRS), through a mutual agreement. The acquisition was completed on February 26, 2025.

Tamibarotene (RN-014) is a retinoic acid receptor agonist for which Rege Nephro is currently conducting a Phase 2 clinical trial in Japan in autosomal dominant polycystic kidney disease (ADPKD). Rege Nephro expects to initiate clinical trials in the United States, after confirming the efficacy and safety in Japan. Syros Pharmaceuticals has previously carried out a Phase 3 clinical trial of Tamibarotene for indications including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

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 the United States.

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), Kyoto University. The company is developing therapeutics and cell therapy for diseases related to the kidneys, liver, and pancreas. For more information, please visit www.regenephro.co.jp/en.

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?

Rege Nephro acquired Tamibarotene-related clinical and non-clinical assets, including safety study data, CMO contracts, and drug products from SYRS.

What is the current development stage of Tamibarotene (RN-014) for ADPKD treatment?

Tamibarotene is currently in Phase 2 clinical trials in Japan for ADPKD treatment.

What were the previous indications for Tamibarotene in Syros (SYRS) Phase 3 trials?

SYRS previously conducted Phase 3 trials of Tamibarotene for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).

What are Rege Nephro's plans for Tamibarotene in the United States?

Rege Nephro plans to initiate U.S. clinical trials after confirming efficacy and safety results from the ongoing Japanese trials.