Cairo, February 20th, 2022:
Minapharm Pharmaceuticals announces the successful completion of the phase 1 clinical trial in Germany evaluating its Teriparatide Biosimilar, Bonosome, a recombinant formulation of endogenous parathyroid hormone (PTH) injection indicated for mild to severe osteoporosis. This achievement marks the first African biosimilar to succeed in a European clinical trial, with an aim to enhance African self-sustainability and provide innovative, quality and affordable medicines to the region.
The product has been submitted for approval by the Egyptian health authorities and is expected to be marketed under the name Bonosome rDNA. End-to-end manufacturing will be performed in Minapharm’s cutting-edge biologics manufacturing facility in Cairo.
The trial was a single center, double-blind, randomized, single dose, fixed-dose, 2-way cross over study of Bonosome rDNA and its reference product FORSTEO® (Eli-Lilly) in 54 healthy female adult volunteers. The primary endpoints of demonstrating pharmacokinetic equivalence between Bonosome rDNA and the reference product FORSTEO® were reached and were within the biosimilarity ranges of 80% to 125%. Secondary endpoints assessing albumin-corrected serum calcium concentrations were also reached and were within the similarity range of 80% to 125%. Further PD endpoints serum phosphate concentrations were confirmed to meet the same bioequivalence ranges.
There were no significant adverse events attributable to Bonosome rDNA, as compared to the reference product. Single doses of 20 µg Teriparatide of either product were safe and well tolerated in all subjects. The overall safety profile was similar for the test and reference product and in line with previous experience with Teriparatide. In addition, no anti-drug antibody positive result was reported for any subject included in the study.
Dr. Jan Rohde, Director R&D Operations and Project Management at Minapharm Pharmaceuticals added, “The successful completion of this trial and the confirmation of the biosimilarity of Bonosome rDNA versus its reference product FORSTEO® is a milestone that marks the successful completion of the development of our Teriparatide biosimilar meeting the highest scientific standards. This success story in the development of Minapharm Pharmaceuticals biologics pipeline is a crucial milestone in realizing our vision of developing affordable and innovative medicines for our region.”
“The successful completion of the first European clinical trial for a product from our portfolio of self-developed genetically engineered therapies demonstrates Minapharm’s regional leadership in the biotech industry. Capitalizing on its quarter century expertise in providing proprietary technologies as well as developing, manufacturing API and commercializing recombination proteins, this milestone further validates the position of the Minapharm group as a global Biotech player.” said Dr. Wafik Bardissi, CEO and Chairman of the Board at Minapharm Pharmaceuticals.