Omega Therapeutics Gets FDA Nod For Initial-Stage Liver Cancer Study

The U.S. Food and Drug Administration (FDA) has announced clearance to Omega Therapeutics’ OMGA Investigational New Drug (IND) to initiate a Phase 1/2 clinical study of its candidate OTX-2002 for the treatment of hepatocellular carcinoma (HCC).

The Phase 1/2 clinical trial will evaluate the safety and preliminary antitumor activity of OTX-2002 which is expected to commence in the second half of 2022.

OTX-2002 is an Omega Epigenomic Controller (OEC) designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

Mahesh Karande, President and Chief Executive Officer, commented : "We are thrilled to obtain clearance to advance OTX-2002 into the clinic and are excited about the prospects of what this new class of medicines may mean for patients in need. This is an important milestone for our company, representing our first program to receive FDA clearance to enter the clinic and the first ever clinical trial to evaluate an epigenomic controller.”

Price Action : Omega Therapeutics shares are trading around 2 percent down at $4.25 on Thursday during after hour session.