Ablynx Announces New Compelling Results on OZORALIZUMAB (ATN-103) in Rheumatoid Arthritis - Gilde Healthcare

Ablynx Announces New Compelling Results on OZORALIZUMAB (ATN-103) in Rheumatoid Arthritis

June 25, 2012
  • 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.”

About Ablynx

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.

Gilde Healthcare company LAVA Therapeutics announces exclusive worldwide license agreement with Seagen to advance LAVA-1223, a Preclinical Gamma Delta Bispecific T Cell Engager

Seagen Inc. (Nasdaq: SGEN), a world leader and pioneer in antibody-drug conjugate (ADC) therapies, and LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody™ platform of bispecific gamma delta...
September 26, 2022

Gilde Healthcare portfolio company Moximed’s MISHA™ Knee System Achieves Superiority of Primary Endpoint in Pivotal Study

Moximed, a medical device company on a mission to improve the standard of care for people suffering with chronic knee pain due to osteoarthritis (OA), today announced clinical results presented at the 12th Orthopaedic Summit...
September 23, 2022

Gilde Healthcare portfolio company Amphista Therapeutics named as a “Fierce 15” biotech company of 2022

Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced that Fierce Biotech has named it as one of 2022’s Fierce 15 biotechnology companies, designating it as one of the most...
September 12, 2022