Ablynx said today it will seek a new partner to develop its Phase III-ready rheumatoid arthritis (RA) candidate vobarilizumab after AbbVie opted not to license the compound following mixed Phase IIb results.
Ablynx also said it will begin End-of-Phase II and scientific advice meetings with the FDA and European Medicines Agency as it prepares to advance vobarilizumab into Phase III trials.
“We are absolutely committed to progressing this program and will therefore start the preparations for the Phase III study with the first patients expected to be enrolled by the end of 2017,” Ablynx CEO Edwin Moses, Ph.D., said in a statement. “We are obviously disappointed that AbbVie has decided at this time not to exercise its right to license vobarilizumab in RA.”
AbbVie’s decision has come more than 2 months after Ablynx disclosed topline results from its second Phase IIb study of vobarilizumab, a Nanobody® therapy designed to fight arthritis by targeting the interleukin-6 (IL-6) pathway through its IL-6 receptor.
In the study, 345 patients with moderate-to-severe arthritis who were already being treated with methotrexate (MTX) were assessed for response to vobarilizumab. In results disclosed August 9, Ablynx said the study showed that on one measure, clinically meaningful improvement in Health Assessment Questionnaire disability (HAQ-DI) score, MTX plus placebo generated improvement in 71% of patients, compared with between 65% and 71% on various dosages of vobarilizumab.
However, the study also showed that on the primary endpoint, the percentage of patients with 20% improvement in tender and swollen joint counts and improvement in three of five other disease-activity measures following 12 weeks of treatment, vobarilizumab generated between 72% and 81%, depending on dosage, compared with 62% treated with methotrexate and placebo.
In addition, the study showed increased percentages of patients with 50% and 70% improvement following treatment with the compound compared with MTX and placebo. At the 50% improvement, improvement with various dosages of vobarilizumab ranged from 29% to 45%, compared with 28% for MTX plus placebo. And at the 70% level, vobarilizumab dosages generated improvement in between 14% and 21% of patients, compared with 9% on the MTX/placebo combo.
“The strong Phase IIb results in RA demonstrated that vobarilizumab is not just another antibody but a member of a new therapeutic class with unique differentiating features resulting in a superior efficacy and safety profile as compared to other biologicals,” Dr. Moses added.
In 2013, AbbVie paid $175 million upfront for licensing rights to vobarilizumab, then called ALX-0061, as part of a broader inflammatory disease collaboration that could have generated up to $840 million for Ablynx.