KRAKOW, Poland, Feb. 14,
2024 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a
clinical-stage drug discovery and development company focusing
on novel small molecule therapies that address emerging targets
in oncology, announced today that the first patient has been
dosed with the study drug in a Phase II clinical trial
investigating RVU120 as a monotherapy for the treatment of patients
with relapsed/refractory acute myeloid leukemia (r/r AML) and
high-risk myelodysplastic syndromes (HR-MDS) – the RIVER-52
study.
- The primary goal of the RIVER-52 study will be to evaluate
safety and efficacy of RVU120 in a larger population of patients
with genetically defined subtypes of AML, including NPM1
mutations, as well as with HR-MDS. The evaluation will be conducted
at the dose level of 250 mg EOD (Every Other Day), identified in
the Phase Ib clinical study, where numerous signs of clinical
activity have been observed.
- The RIVER-52 study is initially launching at clinical sites in
Poland and Italy. Ultimately, the study will expand to
other EU and non-EU countries, covering up to 80 clinical
sites globally. The planned overall enrollment is up to approx. 140
patients.
- The study is part of RVU120's Development Plan presented in
October 2023 and aligns with the
company's cash runway to Q1 2026.
- In H1 2024, Ryvu plans to launch four Phase II RVU120
clinical studies in r/r AML, HR-MDS, LR-MDS and myelofibrosis, and
plans to enroll over 100 patients by the end of the year. Ryvu aims
to prioritize further development options in Q1 2025 based on the
study outcomes. Clinical trials conducted in various hematological
indications and treatment regimens (monotherapy and combination
therapy) will contribute to the global RVU120 safety database,
supporting potential future regulatory approvals.
RVU120 is a selective, first-in-class dual CDK8/19 kinase
inhibitor developed by Ryvu Therapeutics. RVU120 monotherapy has
demonstrated clinical activity in a Phase Ib study, where 50%
of evaluable patients with r/r AML or HR-MDS achieved clinical
benefit, including a complete response, a morphologic leukemia-free
state, transition to a bone-marrow transplant, two-year disease
stabilization, multiple clinically significant blast reductions,
hematologic improvements, and reduction of bone marrow
fibrosis.
Hendrik Nogai, M.D., Chief
Medical Officer of Ryvu Therapeutics, said:
- We are pleased to announce the initiation of another
RVU120 Phase II study, in line with the development plans
presented last year. Based on the demonstrated safety profile
and observed signs of activity from the Phase Ib study in
patients with r/r AML or HR-MDS, we continue to be at the
forefront of developing first-in-class CDK8/19 inhibitors.
This marks a significant step towards our goal of effectively
treating various hematological diseases and providing
therapeutic options for patients with unmet medical
needs.
Kamil Sitarz, Ph.D., Chief
Operating Officer of Ryvu Therapeutics, said:
- With up to 80 clinical sites planned worldwide and a
global operational focus, we aim to maximize efficient patient
enrollment and ensure the timely execution of the RIVER-52 study,
moving RVU120 towards a potential accelerated regulatory approval
pathway.
RIVER-52 is a multicenter, open-label clinical trial
designed to evaluate RVU120 in adult patients with r/r AML and
HR-MDS, without alternative therapies. The study aims to assess the
safety, tolerability, anti-tumor activity (efficacy),
pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 as
a monotherapy in the above-mentioned patient populations.
The study is divided into two parts. Part 1 aims to assess the
level of anti-tumor activity in patients with genetically
defined subtypes of AML, including NPM1 mutations, and in patients
with HR-MDS. Based on the outcomes of Part 1, Part 2 will
further evaluate the safety, tolerability, and anti-tumor activity
in a larger group of patients within the subtypes that exhibit
the highest sensitivity to RVU120.
The study has received approval from the Competent Authorities
in Poland and Italy following a clinical trial application
under the European Union Clinical Trial Regulation (EU-CTR)
536/2014, as well as positive opinions from the respective
Ethics Committees, enabling patient enrollment in both countries.
Start-up activities in other EU and non-EU countries are currently
in progress.
RIVER-52 represents the second of the four planned RVU120 Phase
II clinical studies scheduled for launch in H1 2024. In addition to
RIVER-52, Ryvu has already started patient treatment in the
RIVER-81 study (evaluating RVU120 in combination with venetoclax
for treating r/r AML patients). Upcoming plans also include the
initiation of the REMARK study (conducted as an
investigator-initiated trial, exploring RVU120 as a monotherapy for
the treatment of patients with low-risk myelodysplastic syndromes;
LR-MDS) and the POTAMI-61 study (evaluating both monotherapy and
combination therapy for the treatment of patients with
myelofibrosis; MF).
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and
development company focused on novel small-molecule therapies that
address emerging targets in oncology. Internally discovered
pipeline candidates use diverse therapeutic mechanisms driven by
emerging knowledge of cancer biology, including small molecules
directed at kinase, synthetic lethality, and immuno-oncology
targets.
Ryvu's most advanced programs include RVU120, a selective
CDK8/CDK19 kinase inhibitor with the potential to treat
hematological malignancies and solid tumors, currently in Phase II
development (i) as a monotherapy for the treatment of patients
with relapsed/refractory acute myeloid leukemia (r/r AML) and
high-risk myelodysplastic syndromes (HR-MDS) as well as (ii) in
combination with venetoclax for the treatment of patients with r/r
AML. Another clinical program, SEL24 (MEN1703), is a dual PIM/FLT3
kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics
has signed multiple partnering and licensing deals with global
companies, including BioNTech and Exelixis.
The Company was founded in 2007 and is headquartered in Kraków,
Poland. Ryvu is listed on the
Warsaw Stock Exchange and is a component of the mWIG40 index. For
more information, please see www.ryvu.com.
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SOURCE Ryvu Therapeutics