SEEKING PATIENT REFERRALS

Dear Colleagues,

I am writing to inform you about a research study for a new medical therapy for severe alcoholic hepatitis and to ask you to consider referring your patients to me for possible inclusion in the study.  As you know, severe alcoholic hepatitis remains an unmet medical need with high mortality. SZN-043 is a novel antibody fusion protein based on Wnt biology that targets and promotes hepatocyte proliferation. In a phase 1 study, target engagement and safety has been demonstrated in patients with cirrhosis.

Planned dosing in this study will occur at multiple sites in North America, Europe, UK, and Australasia:

• Intravenous injection of 0.5 mg/kg, 1.0 mg/kg, and 1.5 mg/kg in 3 separate cohorts

• Dosing twice in one week (Day 0, Day 4) as inpatients

• Administration and observation by qualified staff in hospital and later in the liver research unit

• Frequency, dose concentration and number of cohorts could change based on emerging data

• Participants will be expected to return after discharge, total follow up window will be 90 days

We are looking for patients who meet the following criteria:

• Male or female adults

• Hospitalized with a clinical diagnosis of AH:

  • Onset of jaundice within prior 8 weeks;

  • History of heavy alcohol abuse: >40 (female) or 60 (male) g alcohol/day for greater than or equal to 6 months;

  • Consumed alcohol within 8 weeks before study entry;

  • AST >50 IU/mL, AST/ALT >1.5, and both values are: <400 IU/L, and

  • Serum total bilirubin >50 mmol/L

• MELD score of 21 to 30, inclusive

• No expectation of liver transplant while in the study

Patients with severe alcoholic hepatitis will be transferred as inpatients to Ward 71, Auckland City Hospital. Following discharge, patients will be seen at the Liver Research Unit, Level 14, Support Building, Auckland City Hospital. Patient’s accommodation in Auckland and transport to and from home will be provided by the study. Transport and accommodation of one support person will also be provided.

My colleagues David Orr, Dominic Ray-Chaudhuri, Hannah Giles and I look forward to speaking with you at any time about potential patients who may be interested in participating in this study.

For further information about this study, please do not hesitate to contact either myself (021 548371 or email edgane@adhb.govt.nz). Alternative contacts at Liver Research Unit, Level 14, Auckland City Hospital are Research Physician Dr Mitee Kapadia (021 2409 166; or email miteek@adhb.govt.nz ), and Study Coordinator Manesh Patel (093074949 ext 23715 or 021775171 or email: manishp@adhb.govt.nz)

Kind regards,

Ed Gane
Professor - University of Auckland
Deputy Director - NZ Liver Transplant Unit