Polaris Group Announces First Patient Successfully Dosed with ADI-PEG 20/Placebo in Phase 2a Non-Alcoholic Steatohepatitis (NASH) Study

TAIPEI, Taiwan and SAN DIEGO, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the first patient was successfully dosed in the Phase 2a clinical study for Non-Alcoholic Steatohepatitis (NASH).

NASH, a progressive liver disease closely associated with obesity and metabolic syndrome, poses a significant public health challenge. With limited treatment options available, Polaris Group is committed to developing innovative therapies to address this unmet medical need.

Polaris Group's NASH Phase 2a study is a multicenter, randomized, double-blind, placebo-controlled trial that will include 60 patients from at least 5 clinical sites across Taiwan that aims to evaluate the safety, tolerability, and preliminary efficacy of our investigational drug ADI-PEG 20 (pegylated arginine deiminase, pegargiminase) in patients with NASH. Participants will receive ADI-PEG 20 or a placebo to assess the drug's impact on liver fat content, liver histology, and various other endpoints.

"We are excited to reach this pivotal moment in our NASH program," said Howard Chen, Chairman and CEO at Polaris Group. "The first patient dosed marks the initiation of a study that has the potential to make a real difference in the lives of those suffering from NASH. Polaris Group is committed to advancing innovative treatments, and this milestone underscores our dedication to improving patient outcomes."

The study is part of Polaris Group's broader commitment to pioneering advancements in the treatment of metabolic diseases. The company's investigational drug, ADI-PEG 20, holds promise as a potential therapy for NASH. By targeting key pathways involved in NASH pathogenesis, this innovative drug has the potential to address the root causes of the disease.

About Polaris Group

Polaris Group is a biopharmaceutical company dedicated to pioneering advanced therapies, primarily focusing on metabolic related diseases. Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is presently advancing through the BLA-enabling stage and clinical development. Pegargiminase is designed to disrupt cancer cell metabolism, providing a novel approach to treating a wide range of cancers heavily influenced by metabolic pathways. Our mission is to revolutionize the treatment of complex diseases like cancer by concentrating on their metabolic foundations, ultimately striving to enhance patient outcomes globally.

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