NEW
YORK, Feb. 13, 2025 /PRNewswire/ -- Accropeutics
Inc. (Accropeutics), a clinical-stage biotechnology company
pioneering the development of novel therapeutics that target
molecular mechanisms of regulated cell death for immune mediated
diseases, today announced the dosing of their first patient in the
Phase Ib clinical trial of AC-101. AC-101 is a novel RIPK2
inhibitor being developed for the treatment of moderate-to-severe
Ulcerative Colitis (UC). This multi-center, open-label clinical
trial will evaluate the safety, tolerability, preliminary efficacy,
and pharmacokinetics of AC-101 in Chinese patients with
moderate-to-severe UC. Accropeutics recently secured U.S. FDA IND
clearance for AC-101 to enable its planned Phase 2 Multi-Regional
Clinical Trial (MRCT) for this indication.
Dr. Xiaohu Zhang, co-founder
and CEO of Accropeutics said, "Dosing of the first patient in
AC-101's Phase 1b study represents a
significant step towards advancing this novel oral therapeutic for
treatment of patients suffering from Ulcerative Colitis. We believe
that RIPK2 comprises a critical target in the pathogenesis of
inflammatory bowel disease, including Ulcerative Colitis and
Crohn's Disease, and that targeting it with AC-101 will provide a
novel front-line option to patients in urgent need of efficacious,
non-immunosuppressive treatments."
About Ulcerative Colitis (UC)
Ulcerative Colitis (UC), is a chronic, immune-mediated,
inflammatory disease of the digestive tract, characterized by the
inflammation of the large intestine and an intermittent
relapsing–remitting disease course. Recurring UC flares lead to
significant cumulative morbidity and long-standing disease is
associated with significant risk of developing colorectal cancer.
Patients with active disease are more likely to experience
psychological comorbidity, including stress, anxiety and
depression, that significantly impair their quality of life and
work productivity. While many advanced therapeutics exist to manage
moderate-to-severe UC, the majority of these drugs associate with
less than impressive clinical remission rates (20–30%), along with
a high incidence of secondary loss of response in patients who
initially responded.
About RIPK2
Receptor interacting protein kinase 2 (RIP2 or RIPK2) is a
member of the receptor interacting serine/threonine protein kinase
family. NOD/RIPK2 dependent signaling pathway dysregulation is
implicated in several forms of immune mediated inflammatory
disease, including inflammatory bowel disease (IBD) and
sarcoidosis.
About AC-101
AC-101 was developed from the company's "regulatory cell death
and inflammation" drug discovery platform. Preclinical studies show
that AC-101 effectively inhibits the release of the NOD-RIPK2
dependent inflammatory factors and significantly protects tissue
damage in nonclinical in-vivo models. AC-101 has completed Phase I
clinical testing in Australia and
China with evidence of strong
safety and PK/PD signal.
About Accropeutics
Accropeutics Inc. is a clinical-stage biotechnology company
pioneering the discovery, development and commercialization of
novel therapeutics for immune mediated inflammatory disease, by
targeting molecular mechanisms of regulated cell death. The company
has a robust portfolio of innovative compounds in various stages of
development, ranging from lead optimization to clinical testing.
AC-003, a selective RIPK1 inhibitor, completed phase I clinical
testing in China and the United States, and is undergoing phase Ib
clinical trials in aGVHD. AC-201, a selective TYK2/JAK1 inhibitor,
has completed Phase I testing in Australia and China, and is currently undergoing a Phase II
psoriasis trial in China. The
Accropeutics portfolio additionally includes several assets in
research and preclinical stages of development. Accropeutics
entirely owns global rights for all of its assets, and boasts 23
issued patents in China,
Japan, Korea, US and the EU.
Contact:
Accropeutics
Kenneth Gao
Senior Vice President
kenneth.gao@accropeutics.com
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SOURCE Accropeutics Inc.
