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news.US-based biopharmaceutical firm Oncobiologics has reported positive results from a Phase I clinical trial of its first biosimilar molecule, ONS-3010, a highly biosimilar version of adalimumab (Humira), an anti-TNF-α monoclonal antibody, to treat multiple inflammatory diseases.
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The company has reported that ONS-3010 met the primary endpoints in its first-in-human study, which was conducted by the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands.
A three-arm single-dose pharmacokinetic (PK) trial was conducted in healthy volunteers to compare ONS-3010 to both the US- and EU-sourced Humira reference products, and the two reference products to each other.
According to the company, all of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125%.
The trial showed that safety and immunogenicity were similar across the three arms, while an exploratory ex vivo pharmacodynamic study also demonstrated encouraging results between ONS-3010 and the reference products on TNF-a blockade and the induction of specific inflammatory responses.
Adalimumab is approved in many countries to treat multiple inflammatory diseases that include rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis, as well as several pediatric indications.
Oncobiologics chief medical officer Dr Claude Nicaise said: "We are excited to report that ONS-3010 has met the PK endpoints, which strengthens our confidence in achieving the global development of ONS-3010 as a biosimilar to Humira."
The company said that ONS-3010 has the same amino acid sequence, pharmaceutical dosage form, and strength but contains a formulation of different composition.