OBP-601 (Censavudine) is a novel small molecule nucleotide reverse transcriptase inhibitor (NRTI) for HIV infection and is effective on a wide range of resistant virus strains. After getting exclusive worldwide license from Yale University in 2006, Oncolys completed preclinical, CMC, phase 1a, phase 1b/2a and phase 2b clinical studies and have been preparing phase 3 clinical study. OBP-601 has a potential to show better profile on safety having less side effects such as nerve damage, bone mineral density loss and abnormal lipid metabolism which have been a problems in existing anti-HIV drugs.
In the phase 2b clinical trial involving 296 patients in 17 countries worldwide to explore optimal dosage of OBP-601, OBP-601 showed a potential to be a best-in-class type product for HIV treatment and Oncolys has investigated potential financial structure to conduct phase 3 study, including partnering with a third party. In May 2016, Oncolys signed an option agreement with LBR Regulatory & Clinical Consulting Services, Inc. (LBR), a professional firm based in Florence, Kentucky, USA, aiming to discuss and examine the strategy to advance to Phase 3 of OBP-601.