NeuClone's Ustekinimab Candidate Shines in Phase 1 Trial

Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.

NeuClone’s ustekinumab biosimilar candidate has met end points for similarity to the reference product (Stelara) in a phase 1 clinical trial, according to a company statement.

The reference version of ustekinumab is indicated for treatment of patients with plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The Sydney, Australia-based biosimilar company said its ustekinumab candidate (NeuLara) demonstrated clinical pharmacokinetic similarity to US- and EU-sourced Stelara samples. Safety, immunogenicity, and tolerability profiles of NeuLara also matched the reference product, NeuClone said.

“With successful completion of the phase 1 trial for NeuLara, our ustekinumab biosimilar is now significantly de-risked along its development path to market,” said Noelle Sunstrom, CEO of NeuClone.

“We are on track for a global phase III trial starting in 2021 and to be among the first biosimilar entrants, making this valuable antibody drug available to many more patients with psoriasis and inflammatory bowel diseases,” she said.

There are no ustekinumab biosimilars currently approved or marketed in either the United States or Europe.

Ustekinumab works by interfering with the cytokine signaling process that influences levels of inflammation in the body. In this way, ustekinumab suppresses the immune response and alleviates inflammatory disease.  

The market for Stelara is estimated at $6.6 billion currently and the agent is among the top 10 drugs by sales, with projected 2024 revenues of $7.8 billion, NeuClone said, citing various sources.

For a recent interview with NeuClone's strategic analyst Thomas Wakim about the company's foray into biosimilars for PD-1 inhibitors, click here.