ATH-063 considerably elevated the variety of circulating regulatory T cells (Tregs) throughout all doses and demonstrated enrichment in six well-described genes associated to induced Treg anti-inflammatory actions
No critical opposed results or dose limiting toxicities have been noticed at any dose stage, and ATH-063 demonstrated favorable pharmacokinetics (PK)
The info gives scientific verification for Athos’ Proprietary AI2 (Synthetic Intelligence for Autoimmune drug improvement) computational software program platform which generated ATH-063
LOS ANGELES, CA, Oct 17, 2024 – (ACN Newswire) – Athos Therapeutics, Inc. (“Athos”), a scientific stage biotechnology firm pioneering the event of precision small molecule therapeutics for sufferers with immune-mediated illnesses, right this moment introduced topline outcomes for the corporate’s Part 1 scientific trial of ATH-063, an investigational oral small molecule G9A inhibitor and the corporate’s lead asset in improvement for the remedy of inflammatory bowel illness (IBD).
The scientific trial was a randomized, double-blind, placebo-controlled research in wholesome volunteers designed to guage security and PK in addition to present pharmacodynamic (PD) information to offer affirmation of ATH-063’s proposed mechanism of motion. The trial was carried out as sequential single ascending dose (SAD) (n=32) and a number of ascending dose (MAD) (n=32) arms, and a separate food-effect (FE) (n=12) arm. 4 doses (25, 75, 150, and 250 mg) of ATH-063 have been administered orally.
- PD information confirmed ATH-063 selective growth and activation of Tregs, in keeping with predictions made by Athos’ AI2 platform:
- Statistically vital will increase (p<0.001) within the variety of blood Tregs have been noticed in any respect ATH-063 dose ranges in comparison with placebo topics, and demonstrated correlation between ATH-063 blood ranges and variety of Tregs
- Blood ATH-063 focus positively correlated with improve in a number of key biomarkers of Treg exercise, together with robust correlation with FOXP3 (p=0.003)
- Induced Tregs demonstrated enrichment of six well-described genes associated to Treg anti-inflammatory actions
- STAT5A, a key signaling molecule associated to induced Tregs, was activated in all cohorts and doses (p=0.0003)
- Statistically vital will increase (p<0.001) within the variety of blood Tregs have been noticed in any respect ATH-063 dose ranges in comparison with placebo topics, and demonstrated correlation between ATH-063 blood ranges and variety of Tregs
- PD information demonstrated correlation with key biomarkers of IBD illness exercise, supporting additional improvement of ATH-063 as a remedy for IBD:
- Blood ATH-063 focus correlated (p=0.012)with discount of OSM, a well-established biomarker associated to TNFA resistance
- Blood ATH-063 focus correlated with discount of calprotectin monomers, which is a longtime biomarker for IBD
- ATH-063 was effectively tolerated throughout all dose teams: No critical opposed impact or dose limiting toxicities have been noticed at any dose stage
- Strong PK outcomes and dose proportional will increase in blood ranges: ATH-063 confirmed favorable PK outcomes with dose-proportional will increase in blood ATH-063 concentrations all through the research
“The outcomes of our first-in-human scientific trial of ATH-063 exceeded our excessive expectations,” mentioned Dimitrios Iliopoulos, PhD, MBA, Founder, President & CEO, Athos. “We used the Athos AI2 drug improvement platform to establish a beforehand unrecognized and novel therapeutic goal, to create ATH-063, and to preclinically predict the compound’s proposed mechanisms of motion. We’re delighted that these Part 1 outcomes function scientific verification for the predictions made by the Athos AI2 computational engine” added Dr. Iliopoulos.
“Our Part 1 information confirmed that after every day, oral dosing of ATH-063 was effectively tolerated and confirmed growth of Tregs,” commented Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. “We’re excited to maneuver to our subsequent stage of scientific improvement in topics with reasonably to severely lively ulcerative colitis. The speedy tempo of the ATH-063 program, from preliminary goal identification to a accomplished Part 1 trial, was enabled by way of our progressive method to leveraging Synthetic Intelligence for drug improvement.”
About ATH-063
ATH-063 is a novel, investigational, AI-generated, oral, small molecule, G9A inhibitor in improvement for the remedy of inflammatory bowel illness and different autoimmune illnesses. G9A is a central hub on a gene community that was recognized by the Athos AI2 platform via the mixing of multi-omic and longitudinal scientific information from Athos’ IBD biorepository. ATH-063 is designed to instantly goal G9A enzymatic exercise in human CD4 T cells and GI epithelial cells, performing each by suppressing pro-inflammatory responses via growth and activation of regulatory T cells and inducing direct mucosal therapeutic via regulation of tight junction proteins.
About Athos Therapeutics
Athos Therapeutics is a scientific stage biotechnology firm looking for to develop potential first-in-class therapeutics that considerably impression the lives of sufferers with autoimmune problems and power inflammatory illnesses. The Athos drug improvement platform begins with over 25,000 high-quality affected person samples sourced from premier international hospital techniques. Athos’ AI2 platform identifies novel drug targets by integrating multi-omic and longitudinal scientific datasets and matches them to its small molecule computational chemistry platform. The AI2 platform consists of the Athos information lake, singular well-established omics workflows, and an integrative deep machine studying engine. The corporate’s lead drug compound is ATH-063, an investigational, oral small molecule G9A inhibitor for inflammatory bowel illness.
Athos can be creating a pipeline of extra small molecule approaches for varied autoimmune illnesses.Extra details about Athos Therapeutics could be discovered at https://athostx.com/
Contact:
Athos Therapeutics, Inc.
Keith Hoffman, PhD, Chief Enterprise Officer
khoffman@athostx.com
SOURCE: Athos Therapeutics, Inc.
Sectors: BioTech
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Subject: Press launch abstract
Supply: Athos Therapeutics, Inc
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