- Additional Phase II data (ACR20 84%; DAS28 remission 38%) demonstrates that ozoralizumab could have an important competitive and differentiated position in the $24 billion TNFa market
- Data from the open-label study suggest that ozoralizumab enables individualised treatment, a real breakthrough in TNFa therapy, which could prove beneficial to patients and minimise the treatment cost
- Immunogenicity did not affect the efficacy of ozoralizumab, while it is known to have a big impact on the efficacy of Humira®, the world’s biggest selling anti-TNFa drug
GHENT, Belgium – Ablynx [Euronext Brussels: ABLX], today announced that its anti-TNFa Nanobody, ozoralizumab (ATN-103), for the treatment of inflammatory diseases, showed excellent safety and efficacy results in the 48-week open-label extension (OLE) study of the worldwide and Japanese Phase II trials in the treatment of patients with Rheumatoid Arthritis (RA) who have an insufficient response to methotrexate alone.
Dr Edwin Moses, Chairman and CEO of Ablynx, commented:
“We always believed in this programme and now the data from this long-term study have even positively surprised us. We now have extensive efficacy data that are potentially as good, if not better, than other commercially available anti-TNFa products (and this is a $24 billion market) and, in terms of immunogenicity, an unexpected and potentially major advantage over Humira®, the world’s biggest selling anti-TNFa and any of its biosimilar competitors that may be launched in the future. We believe that we now have the components of a much stronger and differentiating licensing package than we had previously.”
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has over 25 programmes in the pipeline and seven Nanobodies are at clinical development stage. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.