Development-stage biotech company Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate, OTX-2002, has received clearance from the U.S. Food and Drug Administration.
This clearance will allow Omega to take OTX-2002 into a Phase I/II study, making it the first-ever epigenomic controller to enter clinical trials.
Omega first submitted an IND application for OTX-2002 last month. Two weeks later, the company added robust in vivo efficacy data to the candidate’s track record. The preclinical data showed that OTX-2002 treatment in non-human primates strongly suppressed MYC mRNA levels in the liver, mirroring its effect in HCC cell lines. Omega’s candidate also demonstrated good synergy with the current standard of care and with AKT inhibition.
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