Of the total 24 patients evaluated in the Phase Ib study, 11 reported a favourable safety profile and clinical benefit. Credit: CI Photos/Shutterstock.com

Ryvu Therapeutics reported safety and efficacy data from the Phase Ib dose-escalation study of RVU120 in patients with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).

The data will be presented at the Annual European Haematology Association (EHA) 2023 Hybrid Congress, on June 9 in Frankfurt, Germany.

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The open label, dose-escalation Phase Ib study (NCT04021368) of RVU120, small molecule CDK8/19 inhibitor, in patients with AML or HR-MDS, evaluates safety, tolerability, preliminary anti-leukemic activity, as well as pharmacokinetic and pharmacodynamic profiles.

Of the total 24 patients evaluated, 11 reported a favourable safety profile and clinical benefit.

One patient with NMP1-mutated AML treated at 75 mg achieved complete remission. Another patient with AML refractory to prior lines of therapy became eligible for allogeneic stem cell transplantation after treatment at the 110 mg dose.

In addition, enhanced efficacy was reported in the preclinical data of RVU120 in combination with the JAK1/2 inhibitor ruxolitinib (RUX) in myeloproliferative neoplasms from a separate trial.

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Treatment with RVU120 monotherapy and in combination with RUX reported significant reductions of disease manifestation, specifically reductions in WBCs, disease reporter percentages, splenomegaly, and bone marrow/spleen fibrosis, as well as stimulated normal haematopoiesis.

 “These findings reinforce the potential of co-targeting CDK8/19 and JAK1/2 as a promising approach in the treatment of myeloproliferative neoplasms,” said Hendrik Nogai, Chief Medical Officer of the Polish company.

According to GlobalData, AbbVie’s Venclexta/Venclyxto is the market leader in AML with forecasted global sales of $5 billion by 2028.

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