DGAP-News: Biotest AG
/ Key word(s): Research Update
26.05.2020 / 07:00
The issuer is solely responsible for the content of this announcement.
Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen
Dreieich, 26 May 2020. Biotest today announced the completion of the clinical trial 984. In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery. These patients are unable to produce functional fibrinogen themselves, or only insufficiently and are therefore dependent on the administration of external fibrinogen.
The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency. With well over 100 bleeding events treated in a total amount of 35 patients of all age groups, the study is currently the largest prospective clinical trial in this indication. The evaluation of the extensive data is currently underway. First results confirm the high expectations regarding efficacy and safety and form the basis for the approval of the fibrinogen concentrate purified from human plasma.
“We are very pleased to have reached this important milestone in the development of our fibrinogen concentrate. The final results are expected at the end of the 4th quarter of 2020. In addition to IgG Next Generation, this compound is another product manufactured in the new production facility “Biotest Next Level”, explains Dr Andrea Wartenberg-Demand, Vice President Clinical Research and Development.
In addition to congenital fibrinogen deficiency, there is the indication of acquired fibrinogen deficiency. Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called “ADFIRST”. Here, the inclusion of the patients continues. The results of both studies are to serve as the basis for the approval of fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency.
About Biotest’s fibrinogen concentrate
About study no. 995 /
About fibrinogen and fibrinogen deficiency
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
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