Aug 06,2020
Suzhou Ribo Life Science Co., Ltd. has recently obtained an implied license for clinical trials of its innovative ASO drug ISIS 560131, which had been and developed by Ribo, following review by the Center for Drug Evaluation under the National Medical Products Administration. This product is a Class 1 innovative chemical drug that has not been marketed. Ribo acquired from Ionis Pharmaceuticals Inc., USA the exclusive R&D and commercialization rights of the product in China.
Through ASO's unique mechanism of action, ISIS 560131 inhibits metastatic castration-resistant prostate cancer (mCRPC) that is associated with the androgen-dependent or non-androgen-dependent AR pathway. The drug has the potential to overcome the therapeutic limitations of abiraterone and enzalutamide and is expected to fill gaps in clinical needs of drug-resistant patients, especially AR-V7 positive patients.As per the proposed protocol, Ribo will initiate "A phase IIa clinical trial to evaluate the safety, efficacy, and pharmacokinetics of ISIS 560131 in patients with androgen receptor splice variant 7 (AR-V7) positive mCRPC".
ISIS 560131 will be the third oligonucleotide therapeutic product for which Ribo has initiated clinical trials in China. At the end of 2019, Ribo completed patient enrollment in China for a phase III global multi-center clinical trial of the RNAi product QPI-1007 for optic nerve protection. In June 2019, Ribo initiated two phase II clinical trials of the ASO drug ISIS 449884 injection for type 2 diabetes. The clinical trials are proceeding well.
