NeuClone Begins Phase 1 Trial of Proposed Ustekinumab Biosimilar

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The single-dose, double-blind, randomized, 3-arm, multicenter study is being conducted in Australia in more than 200 healthy volunteers.

The primary objective is to demonstrate equivalent pharmacokinetics (PK); the secondary objective is to demonstrate equivalent safety of the biosimilar, which NeuClone has dubbed NeuLara, to the reference ustekinumab, which is also licensed in the European Union. Last year, Johnson & Johnson reported Stelara global sales of $5.2 billion. EvaluatePharma predicts this figure will rise to $7.8 billion in 2024.

NeuLara is the second biosimilar from NeuClone’s pipeline to enter clinical development and is developed in partnership with the Serum Institute of India. A year ago, the company announced that it had begun a phase 1 trial of its proposed trastuzumab biosimilar referencing Herceptin.

In May 2018, the company announced that it had confirmed the similarity of its molecule to that of the reference product using an X-ray crystallography analysis of both primary amino acid sequence and 3-dimensional folding structure, and that the company was scaling up to facilitate the clinical study.

NeuClone’s pipeline of biosimilars being developed with the Serum Institute also includes 4 products in late preclinical development: a denosumab product referencing Prolia, a palivizumab product referencing Synagis, an adalimumab product referencing Humira, and a pertuzumab product referencing Perjeta. The company is working on an additional 14 products that are not yet disclosed.

“Following several years establishing NeuClone as a leading biosimilar company, NeuLara’s entry into clinical development demonstrates our ability to advance multiple biosimilar products that will provide greater access to affordable, life-changing medicines, globally,” Noelle Sunstrom, PhD, MBA, chief executive officer and NeuClone founder, said in a statement.

The NeuLara phase 1 clinical trial is being conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme, which offers a streamlined approach and data output is supported by global regulatory agencies.