ANDOVER, Mass.--(BUSINESS WIRE)--DeuteRx LLC, a clinical stage biopharmaceutical company dedicated to improving racemic drugs, today announced that its President and Chief Executive Officer, Sheila DeWitt, Ph.D., will present at the 2nd Annual H.C. Wainwright NASH Investor Conference on March 19 at 5:20 p.m. ET in New York City. The presentation will focus on DRX-065, a novel mitochondrial function modulator for nonalcoholic steatohepatitis (NASH). DRX-065 is a ‘chiral switch’ of an approved type 2 diabetes drug, pioglitazone, that has demonstrated efficacy for NASH in numerous clinical trials.
A live webcast of the corporate presentation may be accessed on the conference website at http://wsw.com/webcast/hcw3/dtr/. A replay of the webcast will be available on DeuteRx’s website at www.deuterx.com.
About DRX-065 for NASH
DRX-065 is deuterium-stabilized R-pioglitazone. Pioglitazone (pio) is the most extensively studied drug for NASH and demonstrated “resolution of NASH without worsening of fibrosis” in a Phase 4 trial (Cusi, et al., Ann Intern Med. 2016, 165(5), 305-315). Pio’s efficacy is better than several late stage NASH drug candidates and it is the only drug recommended off-label for NASH in the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL). Pio’s use for NASH, however, has been limited due to the PPARγ-related side effects, which include weight gain and edema.
Pio is a mixture of two mirror-image compounds (enantiomers) that interconvert in vivo. Using deuterium, DeuteRx stabilized each enantiomer and characterized their dramatically different pharmacology. In preclinical models, the stabilized R-enantiomer, DRX-065, is a mitochondrial function modulator responsible for all of the NASH efficacy observed with pio. By contrast, PPARγ activity and related side effects are due exclusively to the NASH-inactive S-enantiomer. In the Phase 1 study, DRX-065 provided selective exposure to R-pio and is predicted to have efficacy equivalent to 45 mg pio at a significantly lower dose and without the PPARγ-related side effect of weight gain.
About DeuteRx, LLC
DeuteRx has pioneered ‘deuterium-enabled chiral switching’ (DECS), a revolutionary approach to improve racemic (a mixture of two mirror-image compounds or enantiomers) small molecule marketed drugs and drug candidates intended for patients across multiple therapeutic indications. The development of the single, preferred enantiomer from the parent racemic drug, also known as a 'chiral switch', often leads to drugs with superior therapeutic properties. However, numerous drugs are still developed and marketed as racemic mixtures because their enantiomers chemically interconvert in vivo. To date, DeuteRx has demonstrated the use of DECS to stabilize and characterize the enantiomers of many racemic active ingredients. DRX-065, deuterium-stabilized R-pioglitazone, is in Phase 1 at DeuteRx and is being pursued for NASH and adrenomyeloneuropathy (AMN), a rare monogenic neurological disease. DeuteRx’s second program, DRX-164, is a DECS of avadomide (CC-122). Avadomide is a racemic cereblon E3 ligase modulator (CELMoD®) currently in development at Celgene for hematological malignancies and solid tumors. DeuteRx published preclinical results demonstrating that the anti-inflammatory and anti-tumorigenic effects of avadomide are due exclusively to the S-enantiomer (Jacques, et al., PNAS 2015, 24, 112(12), E1471-1479).
DeuteRx was founded in 2012 and is the second deuterated drug company founded by the team. The first company, Deuteria Pharmaceuticals Inc., founded in 2010, was acquired by Celgene in 2012.
CELMoD® is a registered trademark of Celgene.