Suzhou-based biotech Alphamab Oncology (HKG: 9966) has announced that its China-based Phase II KN019-201 study, assessing the safety and efficacy of its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunosuppressive fusion protein KN019 in active rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), has reached its primary endpoint.
Study Design and Results
The randomized, double-blind, placebo-controlled, multi-center study enrolled 145 patients to compare two different doses of KN019 (5 mg/kg and 10 mg/kg) in combination with MTX against a placebo in combination with MTX. The results demonstrated that the American College of Rheumatology (ACR) criteria (ACR20/ACR50/ACR70) reached the preset superiority standard at both 24 and 48 weeks. In terms of efficacy, the ACR20 response rates for KN019 5 mg/kg combined with MTX and KN019 10 mg/kg combined with MTX were significantly better than those for the placebo combined with MTX. Regarding safety, the data for KN019 5 mg/kg and 10 mg/kg combined with MTX were similar, with no unexpected safety events observed.
KN019 Development and Future Outlook
KN019, which is comparable to the kidney transplant rejection drug Nulojix (belatacept) in terms of amino acid sequence and superior to the severe RA drug Orencia (abatacept) in terms of biological activity and safety, is being developed to treat autoimmune diseases such as arthritis, lupus erythematosus, type I diabetes, and immune-related adverse reactions (irAE) caused by immune checkpoint inhibitors. The positive results from the Phase II study will support the regulatory development of the drug.-Fineline Info & Tech
