Athos Therapeutics, Inc.
Los Angeles, March 30, 2023 (Reuters) /PRNewswire/
– ATH-063 is a novel oral small molecule therapeutic targeting both inflammation and direct mucosal healing in patients with ulcerative colitis and Crohn’s disease –
Athos Therapeutics, Inc. (“Athos”), a clinical-stage biotechnology company pioneering the development of artificial intelligence-based precision small molecule therapeutics for patients with autoimmune diseases and cancer, announced today that it has received a CTN recognition and approval from the Human Research Ethics Committee (“HREC”) to initiate a Phase I clinical trial of ATH-063 in Australia.
The HREC approval is confirmation that Athos has successfully completed all pre-clinical, safety and efficacy testing in animal models required to proceed to a Phase I clinical trial in Australia. In addition to the main objectives of the study’s safety assessment, Athos will also conduct multi-omic molecular and genetic analysis to provide additional principle evidence of the drug’s activity, which will serve as the basis for future studies.
“The recognition of our application to initiate the TGA 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 and Chief Executive Officer of Athos.”The commencement of the clinical development program for ATH-063 after only three and a half years of development represents an important milestone for Athos and illustrates our innovative approach to drug discovery and the world-class capabilities of the Athos team. I am proud of the achievements that Athos in rapidly bringing novel precision medicines to patients,” added Iliopoulos.
“We are extremely pleased with the clearance of ATH-063 into clinical testing and are excited to see what this new class of medicines will mean for patients in need,” said Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. ,, This is an important milestone for Athos as it is our first program to receive regulatory approval for clinical launch and the first ever clinical trial evaluating this novel genomic controller, this new class of therapeutics leverages our breakthrough science and has broad application potential in many therapeutic areas, including IBD, other autoimmune diseases and cancer.”
Information about ATH-063
ATH-063 is a first-in-class, oral, small molecule genomic regulator being developed for the treatment of inflammatory bowel disease, other autoimmune diseases and solid cancers. The ATH-063 gene target is a central node in a gene network identified by the Athos calculator by integrating molecular and clinical data from Athos’ major IBD patient biobanks. ATH-063 suppresses pro-inflammatory responses and initiates direct healing of mucous membranes by regulating tight junction proteins. Athos is also developing blood-based proteome and microbiome biomarker signatures that are expected to correlate with ATH-063 efficacy.
About Athos Therapeutics
Athos Therapeutics is committed to developing world-class medicines that will transform the lives of patients suffering from autoimmune diseases, chronic inflammatory diseases and cancer. The Athos drug development platform begins by examining high-quality patient samples and data sourced from the world‘s leading hospital systems. Athos identifies novel drug targets (hubs) by integrating clinical and molecular datasets into and matching with a disease’s biological network (the disease interactome). its small molecule computational chemistry platform. At Athos, we aim to unravel the complexities of autoimmune and cancer biology by assessing disease heterogeneity at the molecular level and developing precision medicine therapeutics by applying a systems biology approach and stratifying patients into 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 (which was acquired for $12 billion), the medicinal chemist behind two multi-billion dollar FDA-approved drugs (Xtandi and Erleada), and the discoverer of the miR-124 targets, which is currently in a Phase III study in IBD. In addition to ATH-63, the company’s lead compound for inflammatory bowel disease, the Athos pipeline includes small molecule approaches for various autoimmune and cancer diseases
For more information on Athos Therapeutics, visit https://athostx.com/.
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Press contact:
Athos Therapeutics,
Inc.,
Keith Hoffman,
PhD,
Chief Business Officer,
[email protected]
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