Athos Therapeutics, Inc. 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 CTN recognition from the Australian Therapeutic Goods Administration 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."

 

Source:prnewswire.com

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