- Alkermes on Thursday revealed its developmental depression drug ALKS-5461 failed to reach its primary endpoints in two of three phase 3 clinical trials.
- Alkermes is modifying the trial design for its third and final phase 3 trial, Forward-5, by adding patients and re-working the statistical methodology.
- Attempting to salvage something, the R&D team conducted a post-hoc analysis on Forward-4. The team determined patients treated with the 2mg/2mg dose achieved the primary endpoint based on improvements in Montgomery–Åsberg Depression Rating Scale (MADRS) scores.
After Richard Pop, CEO of Alkermes, talked up the anticipated success of ALKS-5461 at the recent JP Morgan meeting, investors were expecting positive results. So when the results were not positive, the stock tumbled precipitously.
There are numerous red flags here. Not only did the two trials fail, but the Alkermes team was forced to adjust its third study.
A lot depends on Forward-5. If results are successful, Alkermes plans to combine Forward-5 with the post-hoc data from Forward-4 that demonstrates efficacy. Given these two initial setbacks, a successful third trial will be key for the drug to have a hope of gaining FDA approval.