Pharma Focus Europe

Ryvu Therapeutics Initiates Dosing for First Patient in Phase II Study (RIVER-81) Evaluating RVU120 in Combination with Venetoclax for Relapsed/Refractory AML Treatment

Thursday, February 01, 2024

Ryvu Therapeutics (WSE: RVU) has recently initiated a Phase II clinical trial, RIVER-81 (NCT06191263), in collaboration with venetoclax for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML). The trial aims to evaluate the safety and efficacy of RVU120 in combination with venetoclax, focusing on r/r AML patients who have not responded to prior venetoclax treatment.

The RIVER-81 study is commencing at clinical sites in Poland and Italy, with plans to expand globally to encompass up to 50 clinical sites. The primary objective is to enroll approximately 98 patients, and the study aligns with the company's financial strategy until Q1 2026, supported by a grant of PLN 62.3 million from the Polish Medical Research Agency (ABM).

Ryvu Therapeutics plans to launch four Phase II RVU120 clinical studies in the first half of 2024, aiming to enroll over 100 patients across these studies by the end of the year. The company intends to prioritize further development options in Q1 2025 based on the outcomes of these studies.

RVU120, a dual CDK8/19 kinase inhibitor, has demonstrated positive clinical activity in a Phase Ib study as a monotherapy, with notable clinical benefits in patients with r/r AML or HR-MDS.

Ryvu Therapeutics, expressed optimism about the RIVER-81 study based on encouraging Phase Ib results. The goal is to provide meaningful clinical benefits to AML patients who have failed the current standard of care.

Ryvu Therapeutics, highlighted the successful confirmation of RVU120's safety profile and emphasized the focus on substantiating its efficacy signals. The company aims to dose over 100 patients across multiple Phase II studies by the end of 2024, in line with the development plan and secured financing until Q1 2026.

RIVER-81 is a multicenter, open-label clinical trial designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of RVU120 in combination with venetoclax for adult patients with r/r AML. The study comprises two parts, with Part 1 focused on dose escalation, and Part 2 evaluating selected doses for safety and efficacy in a larger patient group.

The initiation of RIVER-81 marks the beginning of Ryvu Therapeutics' Phase II clinical studies, with upcoming trials including RIVER-52, REMARK, and POTAMI-61, covering various hematological indications and treatment regimens to contribute to the global RVU120 safety database.



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