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Phase 1 ATH-063

Athos Therapeutics Announces Dosing of the First Patient in the First-In-Human Phase 1 Clinical Trial of ATH-063

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

27 April 2023, 11:30 am ET
LOS ANGELES, April 27, 2023 — Athos Therapeutics, Inc. (“Athos”), a clinical stage biotechnology company pioneering the development of artificial intelligence-based precision small molecule therapeutics for patients with immune-mediated diseases and cancer, announced today that the first patient has been dosed in the company’s Phase I clinical trial of ATH-063 in Australia.

“We are very pleased with the rapid start to our first-in-human clinical trial of ATH-063,” said Dimitrios Iliopoulos, PhD, MBA, President & CEO, CEO of Athos. “This is a major milestone for Athos and our Artificial Intelligence-based, precision medicine approach to drug design and development, and the initiation of our trial will provide us important insights into the safety, pharmacokinetics and biologic effects of ATH-063,” added Dr. Iliopoulos.

“We are thrilled to announce the successful administration of ATH-063 to the first clinical subjects in our phase I study,” said Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO.

“With our unique clinical program underway, we look forward to advancing quickly to bring a safe and effective new treatment to the patients who need it most. The short timeframe in which we’ve been able to move from concept to human testing is extraordinary and further demonstrates our abilities and commitment to dedicating our best-in-class resources, from our research and computational programs, to drug design and beyond, in the battle against Inflammatory Bowel Disease and Cancer.”

About ATH-063

ATH-063 is a first-in-class, oral, small molecule, genomic regulator in development for the treatment of Inflammatory Bowel Diseases, other autoimmune diseases and solid cancers. The ATH-063 gene target is a central hub on a gene network that was identified by the Athos computational engine through the integration of molecular and clinical data from Athos’ large IBD patient biorepository. ATH-063 acts both by suppressing pro-inflammatory responses and inducing direct mucosal healing through regulation of tight junction proteins. Blood-based proteomic and microbiome biomarker signatures are also being developed by Athos to correlate with ATH-063 effectiveness.

About the Phase I Trial of ATH-063

While the main goal of the first-in-human Phase I Trial of ATH-063 is safety, Athos will also perform multi-omic molecular and genetic analyses with the goal of guiding the design of future clinical studies by demonstrating additional proof-of-principal of drug activity.

About Athos Therapeutics

The Mission of Athos Therapeutics is to develop first-in-class medications that will significantly impact the lives of patients with autoimmune disorders, chronic inflammatory diseases, and cancer. The Athos drug development platform begins with the interrogation of high-quality patient samples and data sourced from premier global hospital systems. Athos identifies novel drug targets (hubs) by integrating clinical and molecular datasets into the biological network of a disease (the disease interactome) and matches them to its small molecule computational chemistry platform. At Athos, we aim to disentangle the complexity of autoimmune and cancer biology by evaluating disease heterogeneity at the molecular level and develop precision-medicine therapeutics by implementing a systems biology approach and stratifying patients into specific molecular subtypes. Our analytical platform includes the Athos data lake, singular well-established omics workflows, and an integrative deep machine learning engine. The co-founders of Athos include one of the founders of Kite Pharma (acquired for $12B), the medicinal chemist behind two multi-billion-dollar FDA-approved drugs (Xtandi & Erleada), and the discoverer of the miR-124 drug target, currently in a Phase III IBD trial. Along with ATH-63, the Company’s lead drug compound for Inflammatory Bowel Disease, the Athos pipeline includes small molecule approaches for various autoimmune disease and cancer. 

Additional information about Athos Therapeutics can be found at


Athos Therapeutics, Inc.
Keith Hoffman, PhD, Chief Business Officer

SOURCE Athos Therapeutics, Inc.