Gelezen op ander forum met dank aan Calico :
News:
Following the poster publication with details of the multicenter phase II study of its oral rheuma pill (GPGP0634), Galapagos organized yesterday afternoon a conference call to provide more colour on the numbers.
The details confirm our previous views when the poster abstract came out in May that the efficacy demonstrated in this second trial is less clean and not as stellar as suggested in the first study.
Our View:
We remind investors that the ACR20-readout was not statistically significant for none of the 4 doses tested. ACR20 of 65% was recorded on the 300 mg versus 41% of patients on placebo (pcb, a rather high response), or a relative improvement of 24% (a medium result for the recruited patient population). At the first PoC study, ‘634 (200mg/day) showed an ACR20 response of 83%, versus a placebo of 33% (which is a normal pcb value) suggesting a relative improvement of around 50% (which is a very strong result). While the 75mg dose did show ACR20 improvement (not significant), the 150mg was not different to pcb and showed no response on ACR50. ACR50 on pcb was 6%, 28% for the 75mg and 45% for 300mg (statistical significant, and a very high score). The 30mg dose was considered sub-optimal.
The question thus arises why the 150mg shows such abnormal results. The company believes that base-line statistics differentiate this arm from the other arms with a number of worst disease characteristics (highest DAS28 of 6.4, highest tender (TJC) en swollen (SJC) joint counts, longest disease duration, etc). In this arm, patients scored quite low on pain assessment, while CRP, TJC and SJC dropped nicely. Also the drop on DAS28 by 1.7 (vs 1.2 pcb), was hardly better than the 75mg arm, though lower than the 2.3 drop for the 300mg. A strong abnormality was seen on the patient’s own ‘Health Assessment Questionnaire’ score for the 150mg. The company argues that the 4 week duration of the trial may betoo short to see effects for the very severe basis-line DAS28 scores (150mg), but in the first PoC study, the 200mg arm dropped also by 2.3 while the baseline DAS28 was also 6.4).
In terms of safety, the product showed at all doses no serious adverse events with no discontinuations. Similar to the first study, a decline in neutrophils was seen at the higher doses, though no neutropenia reported. The highest dose did show some platelet decline. The cholesterol was stable and elevations in liver enzymes stayed below 1.5x for all patients (>3.0x would be considered clinically relevant).
Conclusion:
The more detailed information presented during EULAR tried to rationalize the less clean efficacy profile for the multicenter study. Whether this will be sufficient to (re-)convince investors to step into the stock on the short term remains to be seen. Indeed, since the capital increase (from mainly US investor), the stock dropped by almost 25%, while the US Nasdaq Biotechindex rallied by 13% YTD and European biotech remained flat. With GLPG0634 stuck in its phase 2b for another 2 years (no patients recruited to date), and the IBD test only to report in 1Q14 PoC data, we do not exclude that lack of pivotal news flow may create further pressure on the stock. Target price maintained, accumulate (from long term perspective) sustained.
Conclusie: dead money voor een jaartje of 2. Beter investeren in Griekse overheidsobligaties.