- Alkermes stock surged early Friday, gaining more than 30% the morning after the Dublin-headquarted company announced positive results from its third Phase 3 trial of its drug for major depressive disorder.
- The treatment, known as ALKS 5461, met its primary endpoint, significantly reducing depression scores compared to placebo, as measured on both MADRS-6 and MADRS-10 rating scales.
- With positive results in hand, Alkermes said it would soon request a meeting with the Food and Drug Administration to discuss filing for approval. But the fate of ALKS 5461 is still very much in doubt, despite the success. Two previous late-stage studies both failed to show a statistically significant benefit.
With the stock surge Friday morning, Alkermes gained back some of the value it lost when it reported the failures of the two earlier Phase 3 studies in January.
Even with the optimism surrounding the most recent FORWARD-5 study, the case for potential approval of ALKS 5461 is far from a slam-dunk.
"We see the results as a positive surprise, as we were not sure that the modifications made to FORWARD-5 following the failures of FORWARD-3/-4 would be necessarily adequate for success," wrote Jefferies analyst Biren Amin in an note to investors.
Two doses of ALKS 5461 were tested in FORWARD 5, which was separated into two sequential stages. While the higher 2 milligram dose met the prespecified primary endpoint, the lower 1 milligram dose did not separate significantly from the effect seen in the placebo arm.
Alkermes management was eager to move ahead with its filing plans.
"We believe that we have a robust body of evidence to support a regulatory submission for this important new medicine. We’ll request a meeting with the FDA very soon and map out the next steps with the goal of bringing this potential new important treatment option to patients as soon as possible," said Elliot Ehrich, chief medical officer at Alkermes, speaking on an analyst call Thursday.
Alkermes plans to pool data from FORWARD-5 and one of the two earlier Phase 3 studies, FORWARD-4, which shared similar trial designs. While that study missed its primary endpoint, post hoc analyses on the higher dose group showed a significant improvement, Alkermes claimed at the time.
Management was also encouraged by the safety profile of ALKS 5461, with nausea, dizziness and fatigue the most commonly reported adverse events. "The importance of a favorable safety and tolerability profile should not be underestimated in the case of a new potential treatment option for depression," Ehrich said.
While major depressive disorder is still a major unmet need, Alkermes is shooting for approval in an adjunctive setting, which could limit potential market size. Jefferies predicts peak risk-adjusted annual sales of $361 million in 2024.