NeuClone said phase 1 patient monitoring and blood sampling has been completed for its ustekinumab biosimilar candidate, which is targeted at the $6.6 billion in annual revenue earned by Stelara, a Janssen Pharmaceutical Companies product.
NeuClone Pharmaceuticals announced successful completion of monitoring visits and blood sampling for patients in the phase 1 clinical trial for its ustekinumab biosimilar candidate for treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Ustekinumab is an antibody that targets interleukin-12 and interleukin-23.
The NeuClone biosimilar candidate is NeuLara and it references Stelara, a Janssen Pharmaceutical Companies product that reached global sales of $6.6 billion in 2019 and is anticipated to achieve sales of $7.8 billion in 2024, according to EvaluatePharma. NeuLara is one of several biosimilars developed by NeuClone in partnership with Serum Institute of India.
Over 200 healthy volunteers received a single dose of either NeuLara, US-sourced Stelara, or EU-sourced Stelara, after which they were monitored for up to 105 days. Samples were collected for pharmacokinetic and antidrug antibody similarity testing.
NeuClone said an interim analysis indicates the safety and tolerability profiles were comparable between the 3 blinded treatment arms. The final clinical study report is anticipated in the third quarter of 2020.
"We are delighted with the progress of NeuLara through its phase 1 clinical trial," stated Noelle Sunstrom, chief executive officer and founder of NeuClone, which is based in Sydney, Australia. "Our attention now shifts to the final stages of development required for approval and supply of NeuLara to patients globally."
In December, Neuclone announced that its proposed biosimilar trastuzumab, referencing Herceptin, had met all primary and secondary end points in a phase 1 clinical study that compared the product with its US and EU reference products. The product, also being developed in partnership with Serum Institute of India, will prospectively be sold under the name NeuCeptin if it gains regulatory approval.