RIVER-81 Phase II Trial Initiates with First Patient Dosed in RVU120 and Venetoclax Combo for Relapsed/Refractory AML

Ryvu Therapeutics, a company at the forefront of clinical-stage drug discovery, has initiated a Phase II clinical trial for a novel combination therapy to combat relapsed/refractory acute myeloid leukemia (r/r AML). The study, known as RIVER-81, involves the use of RVU120 in tandem with venetoclax, a treatment approach that has shown promise in previous research.

The trial's primary objective is to assess the safety and effectiveness of this combined therapy in patients who have not responded to prior venetoclax treatments. Initially, the study will be conducted at sites in Poland and Italy, with plans to expand to other locations across the European Union and beyond, eventually reaching up to 50 global clinical sites. The trial aims to enroll approximately 98 patients.

RVU120, developed by Ryvu Therapeutics, is a first-of-its-kind dual CDK8/19 kinase inhibitor. It has demonstrated significant clinical activity in a Phase Ib study, where half of the patients with r/r AML or high-risk myelodysplastic syndromes (HR-MDS) experienced clinical benefits. These benefits included complete responses and significant reductions in blast counts, among other improvements.

Hendrik Nogai, the Chief Medical Officer at Ryvu Therapeutics, expressed optimism about the Phase II RIVER-81 study, citing the positive outcomes from the Phase Ib study and the potential synergistic effects with venetoclax. He noted the limited treatment options and poor prognosis for AML patients who have failed standard care, highlighting the importance of this new study.

Kamil Sitarz, Ph.D., the Chief Operating Officer, emphasized the company's focus on confirming the efficacy of RVU120, following the successful safety confirmation. With the activation of multiple clinical sites, Ryvu plans to enroll over 100 patients in four Phase II studies by the end of 2024. The company will use the treatment outcomes to strategically prioritize further development.

The RIVER-81 study is designed in two parts: the first to determine safe and tolerable dosages through an escalation process, and the second to evaluate these doses in a larger patient group for both safety and efficacy. Approval has been granted by authorities in Poland and Italy, with startup activities underway in other countries.

Ryvu Therapeutics, founded in 2007 and based in Kraków, Poland, is dedicated to developing novel small-molecule therapies for oncology. The company's pipeline includes RVU120 and SEL24 (MEN1703), among others, and has established partnerships with global entities such as BioNTech, Exelixis, Menarini, and Merck. Ryvu is listed on the Warsaw Stock Exchange and is part of the sWIG40 index.