PharmaEssentia Corporation announces presentation of the results of the phase II trial for P1101 + ribavirin in patients with chronic HCV genotype 1 infection at the 25th Conference of the Asian Pacific Association for the Study of the Liver, taking place in Tokyo, Japan from February 20 to 24, 2016 (APASL 2016). Data will be presented by the study coordinating investigator Prof. Wan-Long Chuang (Taiwan) at the HCV parallel oral session on Feb 22nd (15:45-17:45).
"Results from this second exploratory phase II study allow us to further characterize the profile of P1101 in treating chronic hepatitis HCV patients," mentioned Ko-Chung Lin, PhD, founder & managing director of PharmaEssentia Corp. "Due to its innovative features and less frequent injection need, P1101 may be a new treatment option for chronic HCV infection. We are committed to further explore the best possible setting for the drug use within the indication chronic HCV infection, focusing especially the Asian patients suffering from this devastating disease."
Prof. Chuang, who led the study, mentioned that "Although the study is still ongoing, what we observed so far is encouraging. Among patients who have already completed the study, SVR rates were 77% (20/26), 67% (20/30), 93% (13/14), and 58% (7/12) for weekly active comparator pegylated interferon alpha-2a, P1101 180 mcg, 270 mcg, or biweekly P1101 450 mcg, respectively. Safety and tolerability of P1101 are comparable to active control, even at the highest dose of P1101, while P1101 270 mcg group had the best safety profile. Of special note is a strong suggestion that P1101 270 mcg administered weekly in combination with daily oral ribavirin may be more efficacious and safer than the standard PEGASYS 180 mcg weekly + daily oral ribavirin treatment of Asian patients with chronic HCV genotype 1 infection."
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