SEOUL-- May 11, 2023 -- Oncocross, a Seoul-based AI drug discovery and development biotech, announced the completion of phase 1 global clinical trial of OC514, a treatment targeting sarcopenia and other rare muscular diseases. Phase 1 was conducted in Australia.

Sarcopenia, a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength that is often accompanied by age-related issues and cancers, was coded as a specific disease by the CDC and WHO in 2016. Although there are no approved drugs in the market yet, the sarcopenia-related healthcare market is gradually expanding including food supplements.

Oncocross is developing OC514 as a drug-drug combination product designed to prevent or treat sarcopenia using Oncocross’ proprietary AI platform RAPTOR AI™. The study was conducted as a randomized, double-blind, dose-ranging, placebo-controlled to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of OC514 in 28 healthy volunteers.

Oncocross announced that it had demonstrated the objective safety and pharmacokinetic profile of OC514 through the safety evaluation and the analysis of pharmacokinetic parameters according to the doses in this clinical trial. In addition, the company stated that by successfully completing phase 1 clinical trial in Australia, they established the foundation for evaluating the efficacy and safety of OC514 targeting diseases accompanied by muscle diseases such as sarcopenia.

Dr. Yirang Kim, CEO of Oncocross, mentioned, “I believe we have taken a step closer to developing a treatment for sarcopenia, which is a major obstacle not only for the elderly but also for cancer patients,” adding “We will start preparing for the pre-IND with the US FDA for phase 2 clinical trial in multi-sites including the US. This will accelerate our efforts to develop a new drug to address the significant medical unmet needs associated with sarcopenia.”