Eye on Pharma: NeuClone Initiates Phase 1 Trial of Biosimilar Trastuzumab

NeuClone has announced the start of its first-in-human trial of a trastuzumab biosimilar in a phase 1 trial.

The single-dose, randomized, 3-arm, double-blind study in 100 healthy volunteers is being conducted in Australia with the objective of demonstrating equivalent pharmacokinetics and safety of the biosimilar and the reference Herceptin. The trial is being conducted under the Australian Clinical Trial Notification scheme, which offers a data output that is acceptable to multiple regulators, including as the FDA and European Medicines Agency.

"This major milestone offers significant validation of our biosimilar pipeline and partnership with Serum Institute," Noelle Sunstrom, PhD, CEO and founder of NeuClone, said in a statement. "Over the coming years, we will progress multiple biosimilar products through clinical trials and toward registration."

NeuClone also noted that it is planning to initiate a phase 1 trial of its ustekinumab (Stelara) biosimilar in 2019, following completion of the phase 1 trastuzumab study. Earlier this year, NeuClone announed positive results of its analytical studies for the ustekinumab molecule, saying that it had confirmed the similarity of the biosimilar and the reference product using an X-ray crystallography analysis of both primary amino acid sequence and 3-dimensional folding structure.

The company is also at work on a biosimilar denosumab (Prolia, Xgeva), a RANK ligand inhibitor used in the treatment of osteoporosis and other indications. Early this year, NeuClone described its molecule as potential “early market entrant” in the denosumab biosimilar space.

Two other products in NeuClone’s disclosed pipeline are biosimilars targeting adalimumab (Humira) and palivizumab (Synagis), a monoclonal antibody used to help prevent respiratory syncytial virus.