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NEW YORK, NY, USA I February 13, 2025 I 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. SOURCE: Accropeutics

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 [email protected] SOURCE Accropeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED