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Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®
The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints
About this update from Alvotech
[{"type":"text","content":"The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia® and Xgeva®, which both contain denosumab. The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints. A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva® in healthy adult subjects. “We are very pleased with the progress in our AVT03 program. This milestone, and recent positive top-line results from other clinical studies clearly demonstrate our capabilities and the excellence of Alvotech’s biosimilars development platform,” said Joseph McClellan, Chief Scientific Officer. Prolia (denosumab) is indicated for the treatment of osteoporosis in postmenopausal women and for bone loss in adult men and women at increased risk of fracture. Xgeva, which is also denosumab but in a different presentation, is indicated for prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone. It is also indicated for the treatment of giant cell tumor in bone. In the last twelve months before September 30, 2023, reported combined net revenues worldwide from sales of Prolia and Xgeva were over US$6 billion, based on the manufacturer’s reported quarterly sales. About AVT03 (denosumab)AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimiliari...