Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company, announced that dosing has begun in a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers. The clinical study is a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 207 healthy volunteers.
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody that is administered subcutaneously with a syringe or autoinjector. Mepolizumab is currently indicated for the following conditions: 1) as an add-on maintenance treatment of adult and paediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype, 2) as an add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal, 3) the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, 4) the treatment of adult and paediatric patients aged 12 years and older with hypereosinophilic syndrome for =6 months without an identifiable non-hematologic secondary cause.
After the conclusion of the phase 1 study Bio-Thera plans to run a global phase 3 study and request approval for all available indications at the time of filing the BLA/MAA with NMPA, FDA, EMA and other regulatory bodies around the world.
Bio-Thera Solutions is developing several additional biosimilar products for the global market including biosimilar versions of Avastin, Actemra, Cosentyx, Simponi and Stelara. QLETLI, a biosimilar to Humira, and Pobevcy, a biosimilar to Avastin, are approved by the NMPA and being commercialized in China.
Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.
