R&D MODEL & PORTFOLIO
PROJECT START: Clinical trial to start 2016 OVERALL OBJECTIVE: Conduct Phase II/III clinical trials to test the efficacy of a combination of sofosbuvir + ravidasvir OBJECTIVE 2015: Exploratory work
More than 1 million people are estimated to be chronically infected with HCV in Thailand and 400,000 in Malaysia (genotypes 1, 3, and 6). Both countries have been excluded from all global voluntary licensing agreements with drug companies that have developed effective treatments for HCV that include low and some middle income countries. In the short term, DNDi will focus on combining SOF – already registered for hepatitis C – and RDV – a drug candidate developed by Presidio and licensed to Pharco – to evaluate pan-genotypic activity in Thai and Malaysian populations. The study will assess, in real-world settings, the efficacy, safety, tolerability, pharmacokinetics, and
acceptability of a 12-week regimen containing SOF plus RDV in participants infected with HCV, regardless of the HCV genotype, source of transmission (including intravenous drug use), or HIV co-infection, and also in patients with compensated liver disease with or without cirrhosis. For participants with compensated liver cirrhosis, treatment duration will be 24 weeks. A total of 750 subjects will be enrolled, including up to 30% with compensated cirrhosis and up to 20% people who inject drugs, providing data on efficacy and safety of the SOF-RDV combination as well as on treatment compliance. In 2015 the HCV project was undertaking exploratory work on assessing patient needs and project opportunities, recruitment of patients, and fund-raising.
MAIN PARTNERS: Pharco Pharmaceuticals, Inc., Egypt; Presidio
Pharmaceuticals, Inc., USA; Clinical Research Malaysia (CRM), Ministry of Health, Malaysia
50 › DNDi Annual Report 2015