Generon collaborating with Mayo Clinic to initiate a Phase IIa Study

Generon Corporation, a leading biotech company in China, announced today that the US FDA has cleared a phase IIa IND entitled "An open-label, cohort dose escalating study to assess the safety and efficacy of F-652 in patients with alcoholic hepatitis". The clinical study is a multi-center trial led by Dr. Vijay Shah, Chair, Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Generon had reached an agreement with Mayo Clinic to conduct the phase IIa clinical study earlier this year.
The current phase IIa clinical program is a collaboration between Generon and an alcoholic hepatitis consortium funded by the US National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH). The alcoholic hepatitis consortium, "Translational Research and Evolving Alcoholic Hepatitis Treatment (TREAT)" is a joint effort of three institutions: Mayo Clinic, Rochester, MN; Indiana University Health, Indianapolis, IN; and Virginia Commonwealth University Medical Center, Richmond, VA.
The Phase IIa study is a single arm, open-label study to investigate the safety, tolerability, and PK and PD of F-652 in combination with systemic corticosteroids. F-652 will initially be administered once per week for a two-week period, which may then be extended to four weeks. Dr. Vijay Shah commented: "Alcoholic hepatitis is a highly morbid condition with poor pharmacological treatment options currently. We are excited to collaborate with Generon to test the possible role of F-652 through the NIAAA funded alcoholic hepatitis consortium that we participate in."