Ryvu Therapeutics has dosed the first subject in the Phase II RIVER-81 clinical trial of RVU120 and venetoclax for treating adults with relapsed/refractory acute myeloid leukaemia (r/r AML).
The open-label, multicentre trial is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), tolerability, and efficacy of the drug combination.
The trial is structured in two parts: the first part will determine safe and tolerated doses of both agents through dose escalation, while the second part will assess the selected doses in a larger subject group.
Determining the safety and efficacy of RVU120 plus venetoclax in patients who have not responded to previous treatment with venetoclax and a hypomethylating agent is the trial’s primary objective.
The study has commenced in Poland and Italy and will eventually expand to include up to 50 sites across the globe.
The target enrolment for RIVER-81 is approximately 98 subjects.
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This trial is a component of the RVU120 Development Plan, which was unveiled in October 2023 and is in line with Ryvu Therapeutics’ financial projections until the first quarter of 2026.
Its execution is supported by a grant of 62.3m zlotys ($15.5m) from the Polish Medical Research Agency.
In the first half of 2024, Ryvu Therapeutics plans to initiate four Phase II clinical trials for RVU120 and aims to enrol more than 100 patients across these studies by year-end.
RVU120 as a single agent has shown promising results in a Phase Ib study, where half of the evaluable subjects with r/r AML or high-risk myelodysplastic syndromes achieved clinical benefits.
These benefits included complete responses, significant blast reductions, hematologic improvements, and a reduction in bone marrow fibrosis.
Ryvu Therapeutics chief operating officer Kamil Sitarz said: “We have successfully confirmed the safety profile of RVU120, and our focus is now on substantiating its efficacy signals.
“Subsequently, and based on treatment outcomes, we will strategically prioritise further development paths.”