SHANGHAI--(BUSINESS WIRE)--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."
Dr. David Lacey, Chairman of the Generon Scientific Advisory Board, commented that "this is yet another major milestone for Generon. By collaborating with the best medical centers in the alcoholic hepatitis field together with the scientific support of NIAAA and NIH, the results of the F-652 clinical study will hopefully initiate a novel development pathway that could lead to a new and better treatment option for patients with acute alcoholic hepatitis."
Dr. Tom Tang, Chief Medical Officer of Generon, further commented on this important event "F-652 is a first-in-class drug with the potential to fulfill unmet medical needs for multiple indications including alcoholic hepatitis. We are very excited to collaborate with the TREAT Consortium, and are very grateful for the support from NIAAA and NIH. We are committed to bringing innovative medicines to patients worldwide."
About Alcoholic Hepatitis
Alcoholic hepatitis (AH) is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected would present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). Dr. Bin Gao, Chief, Laboratory of Liver Diseases at NIAAA, and his research group initially discovered the protective role of IL-22 in liver injury mouse models induced by ConA and alcohol. It is believed that "IL-22 treatment could be a potential therapeutic option to ameliorate alcoholic liver disease, due to its antioxidant, antiapoptotic, antisteatotic, proliferative, and antimicrobial effects with the added benefit of potentially few side effects" (Ki SH et al. Hepatol. 2010;52:1291; Gao B. Shah VJ. Clin. Res. Hepatol. Gastroenterol. 2015;39 Suppl 1:S7).
F-652 is a recombinant fusion protein containing human interleukin 22 (IL-22) and produced in Chinese Hamster Ovary (CHO) cells in serum-free cultures. Generon is committed to bringing this first-in-class medicine to patients worldwide. Below is an update of its clinical development status.
-Phase I: A Phase I study was conducted in Australia in healthy volunteers. F-652 showed good safety, and expected pharmacokinetic (PK) and biomarker profiles.
-Phase IIa for GvHD: The study entitled "F-652 in Combination with Systemic Corticosteroids for the Treatment of Newly Diagnosed Grade II-IV Lower Gastrointestinal Acute Graft-versus-Host Disease in Hematopoietic Stem Cell Transplantation Recipients" is ongoing and being led by the Memorial Sloan-Kettering Cancer Center (MSKCC), New York, NY.
-Phase IIa for AH: The study entitled "An open-label, cohort dose escalating study to assess the safety and efficacy of F-652 in patients with alcoholic hepatitis" was cleared by the US FDA. The clinical study is being led by Mayo Clinic, Rochester, MN.
-For acute pancreatitis clinical trial: China CFDA IND is approved this month.
About Generon Corporation
Generon (Shanghai) Corporation (Generon) is a leading biotech company located in Shanghai, China focusing on development of innovative biological therapies for global patients. For more information on Generon, please visithttp://www.generonbiomed.com.