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Ryvu Therapeutics Commences Dosing of First Participant in Phase II RIVER-52 Trial, Investigating RVU120 as Sole Therapy for Relapsed/Refractory AML and HR-MDS

Thursday, February 15, 2024

Ryvu Therapeutics (WSE: RVU) has announced the commencement of dosing for the first patient in a Phase II clinical trial for RVU120. This trial, known as the RIVER-52 study, focuses on evaluating RVU120 as a standalone treatment for patients suffering from relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS).

The primary objective of the RIVER-52 study is to assess the safety and efficacy of RVU120 in a broader patient population, particularly targeting genetically defined subtypes of AML such as those with NPM1 mutations, along with individuals with HR-MDS. The chosen dose level for evaluation is 250 mg administered every other day (EOD), which has shown promising clinical activity during the Phase Ib study.

Initially launched at clinical sites in Poland and Italy, the RIVER-52 study is set to expand to include up to 80 clinical sites globally, covering multiple EU and non-EU countries. The anticipated enrollment for this study is approximately 140 patients. The trial is a crucial component of RVU120's Development Plan outlined in October 2023 and aligns with the company's financial runway until Q1 2026.

In the first half of 2024, Ryvu aims to initiate four Phase II clinical studies for RVU120 in various hematological indications, including r/r AML, HR-MDS, LR-MDS, and myelofibrosis. By year-end, the company plans to enroll over 100 patients across these studies. The outcomes of these trials will inform Ryvu's prioritization of further development options by Q1 2025.

RVU120, a selective dual CDK8/19 kinase inhibitor, has demonstrated clinical activity in previous studies, with notable responses observed in patients with r/r AML or HR-MDS. The drug has shown diverse clinical benefits, including complete responses, disease stabilization, and hematologic improvements.

Ryvu Therapeutics, expressed satisfaction with the initiation of the Phase II study, emphasizing the company's commitment to developing innovative treatments for hematological diseases. Kamil Sitarz, Ph.D., Chief Operating Officer of Ryvu Therapeutics, highlighted the global operational focus of the RIVER-52 study, aimed at efficient patient enrollment and timely execution to potentially expedite regulatory approval.

The RIVER-52 study is a multicenter, open-label trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of RVU120 as a monotherapy in adult patients with r/r AML and HR-MDS. Divided into two parts, the study aims to assess anti-tumor activity in genetically defined subtypes of AML and HR-MDS, with plans to expand based on initial outcomes.

Approval for the RIVER-52 study has been obtained from Competent Authorities in Poland and Italy, with progress underway for approvals in other countries. This study represents the second of four planned Phase II trials for RVU120, underscoring Ryvu's commitment to advancing treatments for hematological malignancies.



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