Epirus reports Phase III RA data for Remicade biosimilar
Epirus Biopharmaceuticals Inc. (Boston, Mass.) reported data on Wednesday from a Phase III trial of BOW-015, the company's biosimilar version of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). In 189 patients with severe and active rheumatoid arthritis on stable doses of methotrexate, Epirus said infusions of 3 mg/kg BOW-015 met the primary endpoint of equivalence to Remicade infliximab in the proportion of patients achieving an ACR20 response at week 16 (89.8% vs. 86.4%). There were no observed meaningful differences in safety or immunogenicity between treatment groups. In January, Epirus reported data from a Phase I trial in 84 healthy male volunteers showing a single 5 mg/kg infusion of BOW-015 met the primary endpoint of bioequivalence to Remicade (see BioCentury Extra, Jan. 3).
Epirus plans to submit its first regulatory application for BOW-015 next quarter with additional regulatory applications in "targeted emerging markets" planned for the next 12 months. The company could not be reached for details. ...