RYVU THERAPEUTICS SA (29/2024) Podanie RVU120 pierwszemu pacjentowi w ramach badania klinicznego fazy II REMARK w leczeniu niedokrwistości u pacjentów z zespołami mielodysplastycznymi niższego ryzyka (LR-MDS) / Dosing of the first patient in the REMARK Ph

Raport bieżący 29/2024

Dosing of the first patient in the REMARK Phase II Study of RVU120 for

the Treatment of Anemia in Patients with Lower-Risk Myelodysplastic

Syndromes (LR-MDS)

The Management Board of Ryvu Therapeutics S.A., with its registered

office in Kraków, Poland ("Ryvu", the "Company"), announces that on

September 18, 2024 the first patient has been dosed in the REMARK study

("REMARK Study"), a Phase II clinical trial investigating RVU120 as a

monotherapy for the treatment of patients with lower-risk

myelodysplastic syndrome (LR-MDS).

REMARK Study is an open-label, multicenter Phase II study of RVU120, a

novel small-molecule cyclin-dependent kinase (CDK) 8/19 inhibitor; the

study aims to treat anemia in patients with LR-MDS. In REMARK Study,

RVU120 is being explored as a single agent in patients with LR-MDS who

have exhausted available treatment options.

The REMARK Study is being conducted as_#8239;an_#8239;investigator-initiated study

through the EMSCO network with_#8239;Prof. Uwe Platzbecker, a_#8239;globally

renowned expert in the field of LR-MDS, as the Coordinating Principal

Investigator.

REMARK Study represents the third of four planned RVU120 Phase II

clinical studies scheduled for launch in 2024. Ryvu has already started

patient treatment in the RIVER-81 (r/r AML; RVU120 in combination with

venetoclax) and RIVER-52 (r/r AML and HR-MDS; RVU120 as monotherapy)

studies, as reported by Ryvu in current report 5/2024 dated January 31,

2024, and current report 10/2024 dated February 14, 2024 respectively.

In the near future, the Company also plans to begin patient recruitment

for the POTAMI-61 study, evaluating RVU120 both as a monotherapy and in

combination therapy for the treatment of patients with myelofibrosis

(MF).

Disclaimer: This English language translation has been prepared solely

for the convenience of English-speaking readers. Despite all the efforts

devoted to this translation, certain discrepancies, omissions or

approximations may exist. In case of any differences between the Polish

and the English versions, the Polish version shall prevail. Ryvu

Therapeutics S.A., its representatives and employees decline all

responsibility in this regard.

More information on page: http://biznes.pap.pl/en/reports/espi/all,0,0,0,1

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