Eye on Pharma: Mycenax's Tocilizumab Biosimilar Performs in Phase 1 Trial

Drug maker Mycenax has reported positive phase 1 data for its proposed biosimilar tocilizumab, referencing Actemra.

The reference tocilizumab is an interleukin-6 receptor inhibitor that is approved in the United States for the treatment of rheumatoid arthritis in patients who have had an inadequate response to 1 or more anti—tumor necrosis factor therapies, and can be used as monotherapy or in combination with methotrexate. It is also indicated to treat giant cell arteritis and juvenile idiopathic arthritis.

Mycenax’s double-blind, randomized, 3-arm, parallel phase 1 study of its proposed product was conducted in 190 healthy volunteers in Australia and New Zealand. Three groups received a single intravenous dose (4 mg/kg) of the proposed biosimilar, EU-licensed Actemra, or US-licensed Actemra.

After the dose, the volunteers were observed for 8 weeks to compare the pharmacokinetics (PK), safety, and tolerability of the products. The study’s primary end point was the area under the concentration-versus-time curve, calculated from start of the infusion until infinity (AUC_0-inf).

Results of the study showed that the proposed biosimilar met its primary end point in PK comparison, with the geometric mean ratios of AUC_0-inf for the biosimilar versus the EU- and US-licensed reference products of 96.60% (90% CI, 92.33%-101.06%) and 95.58% (91.30%-100.07%), respectively. According to Mycenax, other PK parameters and the types and incidences of adverse events observed were similar between the 3 groups.

In a statement announcing the positive phase 1 data, Karen Wen, PhD, president of Mycenax, said that the company plans to apply for scientific advice from the European Medicines Agency and Japan’s Medical Devices Agency in the first quarter of 2019 to finalize its phase 3 study design. The company, she said, hopes to secure eventual approval for both intravenous and subcutaneous dosage forms of the biosimilar.

To date, there are no approved biosimilars of the reference tocilizumab. However, it is an attractive candidate for biosimilar developers, as the product is associated with better drug survival and better clinical outcomes than anti—tumor necrosis factor therapies. However, at least 1 other drug maker is targeting the product; in July 2018, Bio-Thera Solutions announced that it was initiating a phase 1 study of its BAT1806. The company hopes to eventually commercialize its biosimilar in China, the European Union, and the United States.