EQS-News: Biotest AG: First patient enrolled in phase II clinical trial for treatment of chronic hepatitis B with hyperimmunoglobulins

PRESS RELEASE

First patient enrolled in phase II clinical trial for treatment of chronic hepatitis B with hyperimmunoglobulins

• High medical need for 300 million patients with chronic hepatitis B worldwide
• Further development of hepatitis B immunoglobulins (HBIG) could offer patients new and much-needed treatment options
• Biotest supports clinical study at Hanover Medical School
• Treatment with HBIGs to be tested for safety and efficacy in patients with chronic hepatitis B virus infection

Dreieich, 8 December 2022. The first of 20 patients has been enrolled in a clinical phase II pilot study for the treatment of chronic hepatitis B at the Hanover Medical School. The monocentric, interventional, clinical phase II study is being conducted under the direction of Prof Dr Heiner Wedemeyer and with the support of Biotest AG.

The aim of the study is to examine whether Biotest AG's hepatitis B immunoglobulin preparations, Hepatect^® CP and Zutectra^®, can be used safely and effectively in patients with chronic hepatitis B and as a potential combination therapy with other therapeutic agents. To date, HBIGs have been used in particular to prevent hepatitis B reinfection after liver transplantation for hepatitis B induced liver failure. The possible use in chronically infected patients will be evaluated in this study. To analyse the effectiveness, the influence on the serum concentration of the surface antigen HBsAg will be measured. HBsAg loss is defined by the European Association for the Study of the Liver (EASL) as a treatment endpoint of chronic hepatitis B. In addition, various immune parameters will be monitored to evaluate if the treatment has a positive effect on the ability of the patient's immune system to defend itself against the virus.

In the trial (ClinicalTrials.gov Identifier: NCT05345990), 20 patients will be treated with HBIGs for 12 weeks by intravenous and subcutaneous administration.

"Nearly 300 million people worldwide live with a chronic hepatitis B virus infection and still cannot be cured. So there is a huge medical need for effective therapies," emphasises Prof Dr Wedemeyer.

Biotest AG is very interested in the results of the study. They may be an important basis for the development of HBIG products in new indications and thus offer patients new and urgently needed treatment options.

About Zutectra^®

Zutectra^® was specifically developed by Biotest for the long-term treatment of patients after liver transplantation preventing hepatitis B virus re-infection. It is worldwide the first ready-to-use hepatitis B immunoglobulin solution in a pre-filled syringe for subcutaneous administration and it gives patients the opportunity of self-administration. This provides the attending physicians and patients with a less-painful, time-saving and simpler treatment option. The European Commission has granted marketing approval to Biotest for the hepatitis B immunoglobulin Zutectra^® in 2009. Zutectra^® is currently marketed in the EU member states and major international markets.

About Hepatect^® CP

Hepatect^® CP is a hepatitis B virus (HBV)-specific hyperimmunoglobulin preparation. Approved in over 40 countries Hepatect^® CP is one of the leading HBV immunoglobulin brands worldwide. It is indicated for the prevention of HBV re-infection after liver transplantation and for immunoprophylaxis of HBV infection. Prophylaxis of HBV infection may be required in case of accidental exposure in non-immunised subjects (e.g. needle stick injury), in haemodialysis patients, until vaccination has become effective, in the newborn of a hepatitis B virus carrier-mother, and in subjects who did not show an immune response after vaccination. Hepatect^® CP is available as ready-to-use solution for intravenous administration.

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,100 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact

Dr Monika Buttkereit
Phone: +49-6103-801-4406
E-mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
E-mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities ID No. 522720; ISIN DE0005227201
Preference shares: securities ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.