– ATH-063 is a new, first-in-class, oral, small molecule treatment targeting both inflammation and direct mucosal healing in patients with ulcerative colitis and Crohn’s disease –

LOS ANGELES, March 30, 2023 /PRNewswire/ — Athos Therapeutics, Inc. (“Athos”), a clinical-stage biotechnology company pioneering the development of precision, AI-based small molecule therapies for patients with immune-mediated diseases and cancer, announced today that it has received CTN recognition from the Australian Therapeutic Goods Administration and has received Human Research Ethics Committee (“HREC”) approval to commence a Phase I clinical trial of ATH-063 in Australia.

The HREC approval is confirmation that Athos has successfully completed all preclinical, safety and efficacy testing in animal models necessary to commence a Phase I clinical trial in Australia. In addition to the primary safety assessment objectives of the trial, Athos will also perform multiomic molecular and genetic analyzes to demonstrate additional evidence of the drug’s primary activity to guide future study design.

“The TGA’s recognition of our application to initiate clinical evaluation of ATH-063 brings us one step closer to introducing a potentially paradigm-changing treatment for people living with inflammatory bowel disease,” said Dimitrios Iliopoulos, PhD, MBA, Chairman and CEO of Athos. “The start of the ATH-063 clinical development program after just three and a half years of development marks an important milestone for Athos and is illustrative of our innovative approach to drug discovery and demonstrates the best capabilities of the Athos team. I am proud Athos’ track record of rapid execution to bring new precision medicines to patients,” added Iliopoulos.

“We are delighted to be cleared to bring ATH-063 into the clinic and are excited about the prospects for what this new class of drugs can mean for patients in need,” said Allan Pantuck, MD, MS, FACS, President , founder and marketing director. “This is an important milestone for Athos, as it represents our first program to receive regulatory clearance to enter the clinical phase and the first clinical trial to evaluate this novel genomic driver. This new class of therapy leverages our innovative science and has broad applicability. potential in many therapeutic areas, including IBD, other autoimmune disorders, and cancer.”

About ATH-063

ATH-063 is a first-in-class, oral, small-molecule genomic regulator under development for the treatment of inflammatory bowel diseases, other autoimmune diseases, and solid cancers. The ATH-063 gene target is a central lynchpin in a gene network that was identified by the Athos computational engine through the integration of molecular and clinical data from the large Athos biorepository of IBD patients. ATH-063 works by suppressing proinflammatory responses and inducing direct mucosal healing through regulation of tight junction proteins. Athos is also developing blood-based microbiome and proteomic biomarker signatures to correlate with the efficacy of ATH-063.

About Athos Therapeutics

Athos Therapeutics’ mission is to develop world-class medicines that have a significant impact on the lives of patients with autoimmune diseases, chronic inflammatory diseases and cancer. The Athos drug development platform begins with the interrogation of patient samples and high-quality data obtained from the world’s leading hospital systems. Athos identifies new drug targets (hubs) by integrating clinical and molecular data sets into the biological network of a disease (the disease interactome) and compares them to its small molecule computational chemistry platform. At Athos, our goal is to unravel the complexity of autoimmune and cancer biology by assessing disease heterogeneity at the molecular level and to develop precision medicine therapies by implementing a systems biology approach and stratifying the patients in specific molecular subtypes. Our analytics platform includes the Athos data lake, unique well-established omics workflows, and an integrative deep machine learning engine. Athos’ co-founders include one of the founders of Kite Pharma (acquired for $12 billion), the medical chemist behind two FDA-approved multibillion-dollar drugs (Xtandi and Erleada), and the discoverer of the drug target miR-124, currently in a Phase III IBD trial. Along with ATH-63, the company’s lead drug compound for inflammatory bowel disease, Athos’ pipeline includes small molecule approaches for various autoimmune diseases and cancer. Additional information about Athos Therapeutics can be found at https://athostx.com/

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