ATH-63 / Athos Therap - LARVOL DELTA

POSTER OF DISTINCTION: RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE 1 STUDY OF ATH-063: A NOVEL, ORAL, ARTIFICIAL INTELLIGENCE-GENERATED DRUG FOR INFLAMMATORY BOWEL DISEASE. (CCCongress 2026) - P1 | "ATH-063 showed an favorable pharmacokinetics profile with no safety signals or dose limiting side effects identified. Furthermore, ATH-063 demonstrated target engagement with induction of a potent increase in the number and activity of blood FoxP3+ Tregs, while suppressing key pro-inflammatory markers. These results justify further clinical evaluation of ATH-063 efficacy in biologics-resistant IBD patients."

Clinical • First-in-human • P1 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CD4 • FOXP3 • IL10 • IL1B • IL6 • ITGAE • NRP1 • S100A8 • STAT5 • STAT5AWqe • TGFB1 • TNFA

Athos Therapeutics Receives US FDA Authorization to Begin Multi-Center Phase 2 Clinical Trial of ATH-063 in Patients with Ulcerative Colitis (ACCESS Newswire) - "ATH-063 is a novel, oral, first-in-class, small molecule therapeutic targeting both inflammation and direct mucosal healing..."

IND • New P2 trial • Ulcerative Colitis

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Athos Therapeutics Inc | Recruiting ➔ Completed

Trial completion • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Athos Therapeutics Inc

New P1 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Athos Therapeutics Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Athos Therapeutics Receives Regulatory Approval to Commence Phase I Clinical Trial of ATH-063 (PRNewswire) - "Athos Therapeutics...announced today that it has been granted a CTN acknowledgement 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 TGA's acknowledgement of our application to initiate clinical evaluation of ATH-063 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with Inflammatory Bowel Disease,' said Dimitrios Iliopoulos, PhD, MBA, President & CEO, CEO of Athos."

New P1 trial • Immunology • Inflammatory Bowel Disease

Athos Therapeutics Announces the Completion of its Oversubscribed Series A Financing (PRNewswire) - "Athos Therapeutics, Inc...announced today the completion of an oversubscribed $15MM Series A financing. The funding will be used to advance the company's pre-clinical and clinical programs, including the initiation of a first in human phase I clinical trial of ATH-63 in 2022. Athos is developing ATH-63 for Inflammatory Bowel Disease, Lupus, other autoimmune disorders, and select cancer indications."

Financing • New P1 trial • Inflammatory Bowel Disease