ATLANTA, GA and BOTHELL, WA--(Marketwired - April 25, 2016) - Cocrystal Pharma, Inc. (OTCQB: COCP),
a company focused on developing novel antiviral therapeutics for human
diseases, announced today that it has initiated a Phase Ia/Ib clinical
study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor
(NNI), for the treatment of chronic hepatitis C virus (HCV) infection.
The study is currently enrolling subjects and has dosed the first
subject with no serious adverse events reported.
"This trial is designed to assess safety and tolerability of CC-31244 in both healthy and HCV infected subjects as the primary endpoint," said Douglas L. Mayers, M.D., Chief Medical Officer of the Company. "Based on the drug's preclinical safety profile, drug resistance profile and low nanomolar in vitro potency, the goal is to determine the antiviral activity and safety of CC-31244 in humans."
"I am delighted to see the first compound based on the Cocrystal Discovery Platform entering the clinic. As a potential best-in-class pan-genotypic NNI, CC-31244 could be used as an important component in an all oral, ultra-short HCV combination therapy," added Dr. Sam Lee, President and co-inventor of this drug.
The multi-center, double-blind, randomized, placebo-controlled single ascending oral dose and multiple oral dose trial is designed to evaluate CC-31244's safety/tolerability, pharmacokinetics including food effect and antiviral activity in up to 88 subjects. The study will include two groups: Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals). The dosing of Group B (HCV infected individuals) will be conducted following the safety and pharmacokinetic review of Group A (healthy volunteers).
About CC-31244
CC-31244, an investigational pan-genotypic NNI, was developed using the Company's structure-based drug design technology and is aimed to deliver high drug levels to the liver of infected individuals to inhibit HCV replication. Based on its favorable preclinical safety profile, potent in vitro pan-genotypic antiviral activity and pharmacokinetic characteristics, CC-31244 was selected for clinical development.
About Hepatitis C
Hepatitis C is a viral infection of the liver that according to The World Health Organization in 2013 affects over 150 million people worldwide. The annual number of deaths due to Hepatitis C is estimated at 350,000 globally or nearly 1,000 per day. Most patients develop chronic infections, which can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. The worldwide market for hepatitis C antiviral drugs was $13 billion in 2014 and is expected to grow to $15.5 billion by 2022.
"This trial is designed to assess safety and tolerability of CC-31244 in both healthy and HCV infected subjects as the primary endpoint," said Douglas L. Mayers, M.D., Chief Medical Officer of the Company. "Based on the drug's preclinical safety profile, drug resistance profile and low nanomolar in vitro potency, the goal is to determine the antiviral activity and safety of CC-31244 in humans."
"I am delighted to see the first compound based on the Cocrystal Discovery Platform entering the clinic. As a potential best-in-class pan-genotypic NNI, CC-31244 could be used as an important component in an all oral, ultra-short HCV combination therapy," added Dr. Sam Lee, President and co-inventor of this drug.
The multi-center, double-blind, randomized, placebo-controlled single ascending oral dose and multiple oral dose trial is designed to evaluate CC-31244's safety/tolerability, pharmacokinetics including food effect and antiviral activity in up to 88 subjects. The study will include two groups: Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals). The dosing of Group B (HCV infected individuals) will be conducted following the safety and pharmacokinetic review of Group A (healthy volunteers).
About CC-31244
CC-31244, an investigational pan-genotypic NNI, was developed using the Company's structure-based drug design technology and is aimed to deliver high drug levels to the liver of infected individuals to inhibit HCV replication. Based on its favorable preclinical safety profile, potent in vitro pan-genotypic antiviral activity and pharmacokinetic characteristics, CC-31244 was selected for clinical development.
About Hepatitis C
Hepatitis C is a viral infection of the liver that according to The World Health Organization in 2013 affects over 150 million people worldwide. The annual number of deaths due to Hepatitis C is estimated at 350,000 globally or nearly 1,000 per day. Most patients develop chronic infections, which can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. The worldwide market for hepatitis C antiviral drugs was $13 billion in 2014 and is expected to grow to $15.5 billion by 2022.
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