GNI Group Announces Clearance of Investigational New Drug (IND) by FDA for F351 Clinical Trials in the Treatment of Liver Fib...
2017年10月10日 - 5:00AM
ビジネスワイヤ(英語)
GNI Group Ltd., (TOKYO:2160) announced that GNI USA, Inc. (“GNI
USA”), the wholly-owned subsidiary of GNI Group, had received U.S.
FDA clearance on September 29 for the Investigational New Drug
application (IND) for F351 (chemical name: Hydronidone) for U.S.
clinical trials in the treatment of liver fibrosis.
F351 is an orally available, small molecule drug candidate with
potential to treat liver fibrosis associated with chronic liver
diseases. The patented new chemical entity (NCE) F351 drug has been
shown to inhibit tumor growth factor (TGF)-ß1-induced collagen
synthesis in hepatic stellate cell (HSC), a major fibrogenic cell
type in the liver. It is also more potent than pirfenidone in
reducing fibrosis in various animal models of liver fibrosis and
kidney fibrosis. F351 is currently in a 240-subject Phase II
clinical trial in China for the treatment of liver fibrosis
associated with chronic hepatitis B infection.
GNI USA intends to initiate necessary procedures to start a
Phase I open label study in the U.S. in early 2018 to determine
safety, tolerability and pharmacokinetics of single and repeated
doses of F351. Preliminary results are expected within 2018.
Dr. Ying Luo, GNI Group’s CEO, said: ”After successfully
developed pirfenidone for iodiopathic lung fibrosis, we have been
carefully screening for other candidates which may provide hope for
liver fibrosis patients. Today’s IND approval is a major milestone
for our company’s R&D strategy.”
GNI Group Ltd. does not expect the aforementioned submission
will impact financial results for the year ending December 31,
2017.
About GNI Group Ltd.
GNI Group Ltd. is listed on the Tokyo Stock Exchange Mothers
Market, Code 2160, with headquarters in Tokyo and subsidiaries in
Hong Kong, Shanghai, Beijing and the United States. In the United
States, GNI Group has, through its wholly-owned subsidiary GNI USA,
Inc., a consolidated subsidiary, Berkeley Advanced Biomaterials
LLC. which is a developer and manufacturer of high-quality,
cost-effective bone grafts substitutes and headquartered in
Berkeley, California. For further information about GNI Group Ltd.,
please visit www.gnipharma.com., and about Berkeley Advanced
Biomaterials, Inc., please visit
http://www.hydroxyapatite.com/.
This press release contains "forward-looking" statements,
including statements related to the Group's plans to pursue
development of product candidates and the timing thereof. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "continue," "expected to", "will" and similar
expressions are intended to identify these forward-looking
statements. There are a number of important factors that could
cause the Group's results to differ materially from those indicated
by these forward-looking statements, including risks associated
with the timing and success of clinical trials and the
commercialization of product candidates. The Group does not
undertake any obligation to update forward-looking
statements.
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GNI Group Ltd.Thomas Eastling, +81 (03)
6214-3600infojapan@gnipharma.com