Ryvu Therapeutics has dosed the first subject in the Phase II REMARK clinical trial evaluating RVU120 as a monotherapy for patients with lower-risk myelodysplastic syndromes (LR-MDS).
The open-label, multicentre trial focuses on treating anaemia in patients with LR-MDS who have exhausted other treatment options.
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Patients in the REMARK trial will receive RVU120 for a minimum of eight cycles (24 weeks), with the primary objective being hematologic improvement through an erythroid response (HI-E).
Secondary objectives include achieving independence from red blood cell transfusions, improving haemoglobin levels, enhancing quality of life, and analysing disease progression and relevant genetic mutations.
The study commencement is based on previous clinical safety and efficacy data, along with robust preclinical evidence.
REMARK is one of four Phase II trials for RVU120 slated for this year.
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By GlobalDataRyvu is also conducting the RIVER-52 and RIVER-81 studies in acute myeloid leukaemia (AML) and is preparing to launch the POTAMI-61 trial for myelofibrosis, which will assess RVU120 in both monotherapy and combination therapy settings.
A small-molecule inhibitor of cyclin-dependent kinase (CDK) 8/19, RVU120 is being assessed for its potential to stimulate erythroid gene expression without causing significant toxicity to the hematopoietic system.
Ryvu Therapeutics chief medical officer Hendrik Nogai said: “We are glad to announce the initiation of the REMARK study for RVU120, which can potentially help patients with lower-risk MDS.
“This study builds upon the promising results from our Phase Ib study in patients with AML and high-risk MDS, where we observed hematologic improvement in several patients, including cases of transfusion independence. The objective is to further assess the safety and efficacy of RVU120 in patients with lower-risk MDS, underpinned by robust preclinical and mechanistic evidence.”
In February this year, the company initiated a Phase II trial of RVU120, dosing the first patient with relapsed/refractory acute myeloid leukaemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS).
