SEOUL-- February 28, 2022 -- Oncocross, an AI-based drug development biotech, announced that it initiated a phase I global clinical trial for ‘OC514’ targeting muscular diseases including sarcopenia.

Oncocross obtained Australia’s Therapeutic Goods Administration (“TGA”) approval on phase I IND application for OC514 on February 14, 2022 and began a clinical trial with healthy adults in Australia on February 23, 2022. The clinical study aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of OC514.

Sarcopenia is a disease characterized by progressive loss of skeletal muscle mass and strength, thereby deteriorating normal physical function. Previously, sarcopenia was considered as a condition that occurs due to aging or other diseases, but it was designated as an independent disease condition by the 10th version of an International Classification of Disease (“ICD”) code in 2016. Accompanied by aging, cancers, and other chronic diseases, sarcopenia lowers the quality of life by weakening overall physical function while worsening the prognosis of the disease. Currently, there is no approved treatment for sarcopenia, thus, is considered as a disease with high unmet medical needs.

Upon completion of phase I, Oncocross plans to conduct phase II clinical trials for OC514, targeting cancer patients accompanying sarcopenia. The company said that OC514 could be one of the world’s fastest AI drugs in development since there are no AI drugs in phase II clinical study to date.

“As a medical oncologist, I saw many cancer patients in a terminal condition or under chemotherapy also suffering from sarcopenia and I felt a strong need for a sarcopenia treatment,” said Dr. Yi Rang Kim, CEO of Oncocross. “OC514 has a significant meaning for us since it is one of the first AI-driven drug candidates for sarcopenia that is going into clinical trials globally. OC514 also demonstrated its efficacy for age-related sarcopenia and rare diseases such as ALS, also known as Lou Gehrig’s disease, and Duchenne muscular dystrophy, in various animal models. We will do our best to develop new drugs that can help numerous patients who are suffering from the diseases.”