DeuteRx Enters Clinical Stage Development with DRX-065 Preclinical data supporting NASH & AMN to be presented at ACS National meeting (Aug 22, 2016)
Deuterium switcheroo breathes life into old drugs Chemical & Engineering News cover story (Jul 4, 2016)
Deuterated drugs draw heavier backing Nature Reviews Drug Discovery (Apr 1, 2016)
DeuteRx Presents DRX-065 for the Treatment of NASH at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) (Nov 11, 2015)
DeuteRx Announces $2.8 Million of Seed Financing to Support Advancement of DRX-065 for the Treatment of Adrenoleukodystrophy (ALD) (Sep 30, 2015)
Drugs that live long will prosper - A simple change to some pharmaceuticals might boost their efficacy, and make a few firms a packet along the way, The Economist (Sep 5, 2015)
DeuteRx Demonstrates Novel Approach to Chiral Switching for Racemic Marketed Drugs and Drug Candidates using DECS Platform - Results with Thalidomide Analogs Published in PNAS (Mar 2015)
Since the 1990s, the development of the single, preferred enantiomer from the parent racemic drug, also known as a 'chiral switch', has resulted in superior efficacy, safety, and/or pharmacokinetic properties. The requirement to study single enantiomers and the potential for abbreviated and expedited development paths is described in the 1992 FDA guidance, The Development of New Stereoisomeric Drugs. A 505(b)(2) or 505(b)(2)-like regulatory path has been successfully implemented for several chiral switches, including Xyzal® and Lexapro®.
Today, numerous drugs are still developed and marketed with racemic active ingredients because the enantiomers chemically interconvert. DeuteRx has discovered that deuterium can enable stabilization and characterization of single, preferred enantiomers while creating new composition of matter patent protection. In 2016, DeuteRx obtained support from the FDA to develop DRX-065, the deuterium-stabilized (R)-enantiomer of pioglitazone, via a 505(b)(2) regulatory path.
DeuteRx is a clinical stage biopharmaceutical company focused on improving racemic drugs for patients. The lead program, DRX-065, is being pursued for nonalcoholic steatohepatitis (NASH) and adrenomyeloneuropathy (AMN), a rare monogenic neurological disease. Other programs include: DRX-164 and other stabilized, single enantiomers of thalidomide analogs (IMiDs®) for oncology and DRX-194 for the treatment of sickle cell disease (funded by an SBIR grant award number R43HL131158).
DeuteRx was founded in December 2012 as a spin-out company from Deuteria Pharmaceuticals Inc. Deuteria was founded in December 2010 and sold to a major biopharmaceutical company in December 2012.