eClinical Technology and Industy News

Omega Therapeutics Announces FDA Clearance of IND Application for OTX-2002, First Omega Epigenomic Controller, for MYC Driven Hepatocellular Carcinoma

  • Represents First Ever Epigenomic Controller, a New Class of Programmable mRNA Therapeutics, to Receive IND Clearance
  • Phase 1/2 Clinical Trial Expected to Launch in 2H’22 and Will Evaluate the Safety and Preliminary Antitumor Activity of OTX-2002

Excerpt from the Press Release:

CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2, first-in-human, clinical study of OTX-2002 for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller (OEC), is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

“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,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “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. This new class of programmable mRNA therapeutics leverages our groundbreaking science and has broad potential applicability in many therapeutic areas.”About OTX-2002

OTX-2002 is a first-in-class Omega Epigenomic Controller™ in development for the treatment of HCC. OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application for OTX-2002 has been cleared by the FDA.

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