#Japan #Kyoto #Rege Nephro #Tamibarotene #Syros Pharmaceuticals

Rege Nephro Acquires Tamibarotene Assets

Rege Nephro Co., Ltd., headquartered in Kyoto, Japan, has made headlines with its recent acquisition of Tamibarotene-related assets from Syros Pharmaceuticals. This strategic move aims to advance their clinical trial operations within the United States, following the promising outcomes observed in Japan.

On February 26, 2025, Rege Nephro finalized the agreement with Syros Pharmaceuticals to obtain both clinical and non-clinical assets associated with Tamibarotene. The drug, known as RN-014, is an agonist of the retinoic acid receptor and is being piloted in a Phase 2 clinical trial focusing on autosomal dominant polycystic kidney disease (ADPKD). The company plans to leverage the data and resources acquired from Syros to catalyze their upcoming clinical trials in the U.S., contingent upon the successful demonstration of efficacy and safety in their ongoing studies in Japan.

Overview of Tamibarotene

Tamibarotene has historically been researched for various applications, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Syros Pharmaceuticals previously conducted a Phase 3 clinical trial exploring these indications before the assets were transferred to Rege Nephro. The acquisition not only includes extensive clinical and non-clinical data, but it also encompasses contracts with a contract manufacturing organization (CMO) and the active pharmaceutical ingredient (API) for Tamibarotene, which is an essential aspect of Rege Nephro's formulation and supply chain planning.

Through this acquisition, Rege Nephro expects to bolster its operational efficiencies as it gears up for clinical trials in the United States, effectively streamlining processes necessary for the integration of these new resources. This represents a significant leap forward for the biopharmaceutical firm, under the leadership of CEO Akifumi Morinaka, as it strives to enhance therapeutic options for patients suffering from kidney diseases.

Background on Rege Nephro

Founded in 2019, Rege Nephro is a clinical-stage biotech firm that has swiftly advanced its position in the sector, drawing on cutting-edge research from Professor Kenji Osafune at Kyoto University’s Center for iPS Cell Research and Application. The company's primary focus is the development of novel therapeutics and cell therapies targeting diseases involving the kidneys, liver, and pancreas. The ambition to initiate U.S.-based trials serves not only to expand their clinical reach but also signifies their commitment to developing innovative treatment pathways for an array of chronic diseases.

The ongoing Phase 2 trial of RN-014 has revealed encouraging preliminary efficacy, with no major safety issues reported thus far. As enrollment for the second stage continues, Rege Nephro aims to provide hope for those affected by ADPKD through their advanced therapeutic developments.

The Future Ahead

The future looks promising for Rege Nephro as they harness the potential of their newly acquired assets from Syros Pharmaceuticals. With a well-defined roadmap ahead, the company is poised to make impactful strides in the field of nephrology and beyond. Their proactive approach in expanding clinical trials in the U.S. represents a major step towards innovation and better healthcare outcomes for patients facing kidney-related health challenges.

For more information and updates on Rege Nephro's advancements, visit their official website at www.regenephro.co.jp/en.