- Phase 1 data from the study expected to be available by December 2018
Aurigene, a biotechnology company focused on discovering and developing drugs for oncology and inflammatory disorders, announced today that it has commenced dosing in INDUS, a Phase 1 trial of AUR-101 in healthy volunteers. The study is designed to evaluate the safety signals, pharmacodynamic modulation, and recommended dosage for Phase 2 studies (RP2D).
AUR-101 is a selective, potent inverse agonist of the receptor RoRγt, designed as an oral agent for the treatment of IL17-driven immunological conditions, including psoriasis. Aurigene expects data from the INDUS study to be available by December, 2018.
Commenting on the trial, CSN Murthy, CEO of Aurigene said "This is the first study of the planned global clinical development for AUR-101; we are excited to have started the clinical evaluation of the compound and expect to mirror the excellent results seen in established pre-clinical disease models".
AUR-101 is a potent, oral RORϒt inverse agonist, with high selectivity across other ROR isoforms and nuclear hormone receptors and expected to confer a superior safety profile. AUR-101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients and also very significant reduction in ear swelling and histopathology scores in two separate pre-clinical psoriasis models. In addition, AUR-101 has been found to be safe in preclinical toxicology evaluations, at several fold of anticipated efficacious doses in humans.
Aurigene is a development stage biotech company, engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene is focused on oral immune checkpoint inhibitors, precision-oncology and the Th-17 pathway. Aurigene currently has three programs from its pipeline in clinical development. Aurigene's oral PD-L1/ VISTA antagonist CA-170 is currently in Phase 2 clinical development in India. Additionally, Aurigene's selective CDK7, CDK12 inhibitors, CD47 immune checkpoint inhibitor, and SMARCA2/ 4 degraders are at different stages of pre-clinical development. Aurigene has partnered with several large- and mid-pharma companies in the United States and Europe and has delivered over 15 compounds currently in clinical development. For more information, please visit Aurigene's website at http://aurigene.com/