TOKYO, July 18, 2024 /PRNewswire/ -- Renalys
Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys Pharma") announced today that
the first person was dosed in its registrational Phase III clinical
trial of sparsentan for the treatment of IgA nephropathy in
Japan.
In April this year Renalys submitted an Investigational New Drug
(IND) Application for sparsentan to the Pharmaceuticals and Medical
Devices Agency (PMDA) in Japan.
The registrational Phase III study is a multicenter,
open-label, single arm study in Japanese patients with IgA
nephropathy, and is planned to confirm the efficacy and safety of
sparsentan in approximately 30 Japanese patients. Results from the
urine protein/creatinine ratio (UP/C) endpoint in the study are
expected in the second half of 2025 to support a submission for
approval to PMDA.
Sparsentan was developed by Travere Therapeutics, Inc.
("Travere"). Renalys Pharma has an exclusive license for
development and commercialization of sparsentan in Japan, South
Korea, Taiwan,
Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the
Philippines, Singapore, Thailand, and Vietnam. In
2023, Travere received FDA accelerated approval for sparsentan
(U.S. brand name: FILSPARI®) to reduce proteinuria
in adults with primary immunoglobulin A nephropathy (IgAN) at risk
of rapid disease progression*. In addition, Travere submitted a
supplemental New Drug Application to FDA in March 2024 which was granted as Priority Review
and a PDUFA target action date of September
5, 2024, to convert the existing U.S. accelerated approval
to full approval based on 2-year confirmatory results from the
Phase III PROTECT Study, the only head-to-head study in IgA
nephropathy versus an active comparator. In the PROTECT Study,
FILSPARI® demonstrated a
significant reduction in proteinuria, preservation of kidney
function and a well-tolerated safety profile compared with active
control irbesartan.
Renalys Pharma is committed to advancing its business to
contribute to improving the lives of patients in Japan and Asia through the development of innovative
therapies that can improve the management of kidney disease, first
and foremost by delivering sparsentan as soon as possible.
*FILSPARI®
(sparsentan) U.S. Indication:
FILSPARI is an endothelin and angiotensin II receptor antagonist
indicated to reduce proteinuria in adults with primary
immunoglobulin A nephropathy (IgAN) at risk of rapid disease
progression, generally a UPCR ≥1.5 g/g.
About IgA Nephropathy
The management of patients with chronic kidney disease (CKD) and
end-stage renal disease (ESRD) has become a social issue that
places a heavy burden on the Japanese healthcare system. IgA
nephropathy is widely known as one of the main causes of kidney
failure and is considered to develop when abnormal IgA proteins are
deposited in kidney tissue, inhibiting kidney function and causing
inflammation. IgA nephropathy is a rare intractable disease
(designated as an intractable disease 66) with many unresolved
mechanisms of onset and severity. Currently, there is a lack of
treatment for IgA nephropathy and an unmet need for such treatment
in Japan.
About Renalys Pharma, Inc.
Renalys Pharma, a privately held late-stage clinical
biopharmaceutical company based in Japan, is committed to the development of
multiple innovative therapeutics targeting unmet needs in the
management of renal disease for Japanese and Asian patients.
Founded by Catalys Pacific and SR One in 2023, the company aims to
address the growing problem of "drug loss" by catalyzing access to
new treatments for kidney disease patients in Japan and other Asian regions.
Company Name: Renalys Pharma, Inc.
Address: 3-11, Nihonbashi-honcho 2-chome, Chuo-ku, Tokyo, Japan
Representative: BT Slingsby, MD, PhD, MPH
Established: April 2023
URL: https://renalys.com/
[Disclaimer]
Information concerning pharmaceutical products (compound under
development) contained herein is not intended as advertising or as
medical advice, but intended for disclosure of management
information.
View original
content:https://www.prnewswire.com/news-releases/renalys-pharma-announces-first-patient-dosed-in-registrational-phase-iii-clinical-trial-of-sparsentan-for-iga-nephropathy-in-japan-302200043.html
SOURCE Renalys Pharma, Inc.