Stockholm, Sweden - Medivir AB (Nasdaq Stockholm: MVIR) today communicates phase IIb data on JNJ-4178, the triple combination consisting of simeprevir, odalasvir and AL-335, following presentations at the 2017 Liver Meeting™ organized by the American Association for the Study Liver Diseases (AASLD) and held in Washington DC on 20-24 October.
SVR12 data from OMEGA-1, a global open-label phase IIb study of the efficacy and safety of JNJ-4178 in non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6, were presented at the conference. The results showed that 98.9% (181/183) of patients treated with JNJ-4178 for 6 weeks achieved SVR12, while 97.8% (178/182) of patients treated with JNJ-4178 for 8 weeks achieved SVR12, with both arms meeting the prespecified endpoint of statistical non-inferiority compared to historic controls. The triple combination was generally well-tolerated in both arms of the study, with the most frequent adverse events being headache and fatigue. Further information on the study can be found at www.clinicaltrials.gov (NCT02765490).
Medivir announced on September 11th 2017 that Janssen Sciences Ireland UC had decided to discontinue the development of JNJ-4178. The discontinuation of development of JNJ-4178 does not affect the ongoing partnership with Janssen on Olysio® (simeprevir), or the existing licensing agreement with Janssen in which simeprevir is included. Medivir continues to be entitled to royalties on sales of single agent simeprevir globally.
For further information, please contact:
Anders Lundin, Interim CFO Medivir AB, mobile: +46 (0)73-125 1453
Richard Bethell, CSO Medivir AB, mobile +46 (0) 72 704 3211
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.