Athos Therapeutics, Inc. ("Athos"), a clinical stage biotechnology company pioneering the development of artificial intelligence-based precision small molecule therapeutics for patients with immune-mediated diseases and cancer, 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.

HREC approval is confirmation that Athos has successfully completed all pre-clinical, safety and animal model efficacy testing required to commence a Phase I clinical trial in Australia. In addition to the main safety assessment goals of the trial, Athos will also perform multi-omic molecular and genetic analyses to demonstrate additional proof-of-principal of drug activity to guide the design of future studies.

"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. "The initiation of the ATH-063 clinical development program after only three and a half years of development marks an important milestone for Athos and is illustrative of our innovative approach to drug discovery and demonstrates the best-in-class capabilities of the Athos team. I am proud of Athos' record of accomplishment for rapid execution in bringing novel precision medicines to patients," added Iliopoulos.

"We are thrilled to obtain clearance to advance ATH-063 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need," said Allan Pantuck, MD, MS, FACS, Chairman, Founder & CMO. "This is an important milestone for Athos, representing our first program to receive regulatory clearance to enter the clinic and the first ever clinical trial to evaluate this novel genomic controller. This new class of therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas, including IBD, other autoimmune disorders, and cancer."