Athos Therapeutics Receives US FDA Authorization to begin Multi-Center Phase 2 Clinical Trial of ATH-063 in Patients with Ulcerative Colitis

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.

LOS ANGELES, January 21, 2026 — Athos Therapeutics, Inc. ("Athos"), an AI software and clinical stage biotechnology company pioneering the development of precision small molecule therapeutics for patients with immune-mediated diseases, announced today that it has been granted US FDA authorization to commence an international Phase 2 clinical trial of ATH-063 in patients with moderately to severely active, biologic-refractory ulcerative colitis.

In addition to the main efficacy and safety assessment goals of the trial, Athos will use their AthosOmics.AI platform to perform multi-omic molecular and genetic analyses to demonstrate additional proof-of-principal of drug activity and mechanism of action, and to guide the design of its future clinical trials.

AthosOmics.AI is a platform that brings multiple no-code, agentic AI software solutions to the growing field of omics analysis. The automated platform can computationally analyze raw, or pre-processed, omics data (genomics, transcriptomics, proteomics, etc) to produce clear, actionable outputs rapidly and at low cost, without the need for bioinformatic, computational or biostatistical expertise.

"We believe that our already completed Phase 1 ATH-063 results represent the first time that an AI drug development platform has been clinically validated. Five years ago, our AthosOmics.AI platform first identified the drug protein target, modelled the 3D protein target and chemical structure of ATH-063, predicted the ATH-063 mechanism of action and, importantly, identified the patient population that has high enrichment for the ATH-063 target, thus helping with the phase 2 clinical trial design," said Dimitrios Iliopoulos, PhD, MBA, President & CEO of Athos.

"Our Phase 2 clinical trial for ATH-063 will build upon these important advances and continue our efforts to provide a paradigm-shifting, precision medicine treatment for people living with therapy refractory Inflammatory Bowel Disease (IBD)," said Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. "Patients no longer responding to current approved therapies represent a large patient population, and we are hopeful that ATH-063 can ultimately be FDA-approved to provide a long-overdue solution for the unmet medical needs of so many IBD patients," he added.

About ATH-063
ATH-063 is a first-in-class, oral, small molecule in development for the treatment of Inflammatory Bowel Diseases. The ATH-063 gene target is a central hub on a gene network that was identified by the AthosOmics.AI computational engine through the integration of molecular and clinical data from Athos' large IBD patient biorepository. ATH-063 has a dual mechanism of action and acts both by suppressing pro-inflammatory responses and inducing direct mucosal healing through regulation of tight junction proteins. Blood and tissue-based biomarker signatures are also being developed by Athos to correlate with ATH-063 effectiveness.

About Athos Therapeutics and AthosOmics.AI
Athos Therapeutics is an AI software and clinical stage biotechnology company seeking to develop first-in-class therapeutics that will significantly impact the lives of patients with autoimmune disorders and chronic inflammatory diseases. The Athos drug development platform begins with over 35,000 high-quality patient samples sourced from premier global hospital systems. The company's lead drug compound is ATH-063, a first-in-class oral small molecule for inflammatory bowel disease is now entering a Phase 2 clinical trial. Athos is also developing a pipeline of additional small molecule approaches for various autoimmune diseases.
The AthosOmics.AI platform identifies novel drug/protein targets by integration of multi-omic and longitudinal clinical datasets from patients. The platform takes the 3D structure of the protein target to drive the computational design of small molecules and provides an evaluation of ADME and safety profiles for such compounds. AthosOmics.AI software is therefore a novel one-stop solution, able to go from raw patient data to drug development. The platform includes the Athos data lake, singular well-established omics workflows, and an integrative deep machine learning engine. AthosOmics.AI successfully predicted the mechanisms of action of ATH-063 years before human clinical trials and is driving the drug asset pipeline of Athos. The platform provides no-code solutions for any industry working with omics data including drug discovery and development, agriculture, law enforcement and forensics, food and beverage, and cosmetic development.
Additional information about Athos Therapeutics can be found at https://athostx.com/

Additional information about Athos Therapeutics can be found at https://athostx.com

Contacts:

Athos Therapeutics, Inc.
Keith Hoffman, PhD, Chief Business Officer
khoffman@athostx.com

Xeptiva Therapeutics
Josefina Correa, MS, Chief Executive Officer
jcorrea@xeptiva.com

Source: Athos Therapeutics, Inc.