Improving Medicines for Patients

News & Events

Poxel and DeuteRx announce Strategic Acquisition and Collaboration Agreement for DRX-065, a Novel Clinical Stage Drug Candidate for NASH, and Other Programs (Aug 30, 2018)

Biochemistry to Bedside Deuterated Drug Molecules: Focus on FDA-Approved Deutetrabenazine (Biochemistry 2018, 57, 472−473)

FASEB Hematological Malignancies 2017 Poster Understanding the Class of Thalidomide Analogs Through the Stabilization & Characterization of Their Interconverting Enantiomers (Jul 2017) - Poster Award

AASLD 2016 Late Breaking Poster Efficacy of DRX-065, the stabilized R-enantiomer of pioglitazone (pio), in choline-deficient (CD) and methionine/choline-deficient (MCD) diet mouse models of nonalcoholic steatohepatitis (NASH) (Nov 2016)

2015 PNAS Publication Differentiation of antiinflammatory and antitumorigenic properties of stabilized enantiomers of thalidomide analogs (PNAS 2015, 24, 112(12), E1471-1479)

Speed to Market

The development of the single, preferred stereroisomer from the parent racemic drug, also known as a 'chiral switch', often leads to drugs with superior therapeutic properties. Some successful and profitable ‘chiral switches’ include Prilosec® to Nexium® and Celexa® to Lexapro®.

However, numerous drugs are still developed and marketed as racemic mixtures because their stereoisomers chemically interconvert . To date, DeuteRx has demonstrated the use of deuterium-enabled chiral switching' (DECS) to stabilize and characterize the stereoisomers of many racemic active ingredients. This DECS approach to deuterated drugs can provide new composition of matter patent protection and a derisked path to approval.

A 505(b)(2) or similar regulatory path has been successfully implemented for several chiral switches as well as deuterated drugs. Notably, the first deuterated drug approved, Austedo® by Teva / Auspex, was developed as an NCE via a 505(b)(2) pathway.

Validated Approach

Since 2010, the team has pioneered deuterium-enabled chiral switching (DECS) of well-known, racemic drugs and/or drug candidates including Revlimid® (lenalidomide), Actos® (pioglitazone), Wellbutrin® (bupropion), and avadomide. Validation of this approach has been demonstrated by asset sales to Celgene in 2012 and Poxel SA in 2018.

Deuteria Pharmaceuticals Inc. (Deuteria) was the first company founded by the team in December 2010. One of Deuteria’s earliest issued patents, U.S. #8,288,414, has claims covering deuterated S-lenalidomide and disclosure of in vitro studies showing stabilization and differentiation of the S- and R-stereoisomers. In December 2012, Deuteria was acquired by and became a subsidiary of Celgene.

DeuteRx, LLC was founded in 2012 with several assets from Deuteria that were not acquired by Celgene. In 2015, DeuteRx's lead program was DRX-065, deuterated R-pioglitazone for the treatment of and nonalcoholic steatohepatitis (NASH) and adrenomyeloneuropathy (AMN). In preclinical studies, DeuteRx discovered that the PPARγ activity and related side effects are due to S-pioglitazone while the predicted efficacy for AMN and NASH are due to R-pioglitazone. In 2016, DeuteRx advanced DRX-065 into Phase 1 human clinical trials. In 2018, Poxel acquired PXL065 (formerly DRX-065) and a portfolio of related assets. Poxel announced completion of the Phase 1 studies and plans to initiate a Phase 2 clinical trial in biopsy-proven NASH patients in Q2 2020 via a 505(b)(2) regulatory pathway.