BERLIN, Germany, March 6, 2023/ — MiGenTra (www.Migentra.com), a Berlin-based healthcare transforming company, reported today that the first participants in a Phase 1 clinical trial for Minapharm Pharmaceuticals adalimumab biosimilar candidate (brand name: Adessia®) were dosed on February 24, 2023 in Germany.
This follows a prior announcement made by Minapharm Pharmaceuticals on February 13, 2023 reporting that said Phase 1 trial received unconditional approval from the Paul-Ehrlich Institut (PEI).
“Our ambition for Africa and the transformation of healthcare is clear: healthcare is a human right and testing the first ever in Africa (Egypt) developed monoclonal antibody biosimilar candidate in Healthy Volunteers in an EMA-regulated country speaks to the quality of analytical data obtained so far and accepted by PEI. Our approach remains holistic and patient centric and directed towards addressing unmet medical needs in Egypt, the Middle East and all of Africa”, said Dr. Lutz Hilbrich, Chief Executive Officer at ProBioGen and MiGenTra and Chief Medical Officer at MiGenTra.
“This milestone is pivotal in the short history of MiGenTra. It validates our scientific approach of leveraging the best of two worlds available at ProBioGen and Minapharm Pharmaceuticals, our founding companies, towards the efficient development of high-quality biosimilar products”, said Dr. Thomas Dümmler, Director Clinical Operations Strategy at MiGenTra.
MiGenTra and Minapharm Pharmaceuticals will be sharing responsibilities to file, launch and commercialize Adessia in Africa and the Middle East.
The Phase 1 clinical trial of Minapharm Pharmaceutical’s adalimumab biosimilar candidate is a multi-center, randomized, double-blind, 2-arm, parallel group trial in 154 healthy male and female participants, comparing the pharmacokinetics, safety, immunogenicity and tolerability of the Adalimumab biosimilar, Adessia, and its reference product Humira®.
Results from the study are expected by the end of 2023.
