bioscience schreef op 9 februari 2017 12:17:
Bron : KBC securities.
Subgroup analysis focussing on ACR20 placebo
News:
Ablynx announced that they will be presenting additional data (2 poster presentations) today from the Phase IIb RA combination study of its anti-IL-6R Nanobody, vobarilizumab, at the Annual Scientific Meeting of the Canadian Rheumatology Association (CRA, 8-11 February 2017). The posters will also come available on the Ablynx website shortly after the conference but the abstract of the posters can already be found on the CRA website.
Our View:
According to the CRA website, we see that one poster (53) highlights the results of the phase IIb study an sich and that the second poster (54) presentation represents the results of a subgroup analysis based on “Access to Biologics” of the study. This subgroup data focusses on the “issue” that was seen regarding the high placebo result on ACR20.
As a reminder: The primary endpoint was the proportion achieving an ACR20 response at Week 12. Early discontinuation was mandatory for patients with <20% improvement in both swollen and tender joint counts at Weeks 12, 16 or 20. Only patients who completed the study could enrol in a 2-year open-label extension study.
Subgroup analysis: ACR response at week 12 was calculated separately for the subset of countries with access to biologicals (e.g. USA, Belgium, Spain) and for the subset without such access. Note that total placebo group was 69 patients. In the subset of countries with widespread access to biologicals, 40% (6/15) of patients in the placebo group achieved an ACR20 response while in the subset without such access a response of 69% (37/54) was observed. Responses in the vobarilizumab dosing arms were 75%, 83%, 72%, and 56%, compared to 76%, 81%, 80%, and 77% in the two subsets, respectively.
Conclusion:
The company shows with this additional subgroup analysis that the placebo response was indeed higher in the geographical region without access to biologics vs the regions that have access, which may have been driven by the forced discontinuation points that were built in the design. This news thus sheds more light on the high ACR20 placebo result and we hope that with this additional information, the company may be able to find a partner more easily and could land a more interesting deal. Partnering will eventually be the main stock trigger for voba and we have to wait for more information on this matter, potentially until the lupus data comes out in 2018. Buy rating and target price reiterated.