Key Highlights:
- Sage Therapeutics’ drug is helping in improving depressive symptoms after three days.
- The investors are doubtful about how long the treatment’s effect would last.
- Sage Therapeutics shares have dropped by 17%.
Sage Therapeutics drug is helping improve depressive symptoms after 3-days in a late-stage study. However, the investors are questioning whether the treatment’s effect would last. This has also crippled the company’s shares by 17%.
A study conducted among 440 patients that demonstrated depressive disorder, Zuranolone-the drug, taken with antidepressant showed that there were significant improvements in the two weeks.
However, the analysts highlighted that the near-term durability of the oral drug will be the decision-maker for broader commercial success.
Trial results raise the question
The Truist Securities analyst, Joon Lee, commented, “The clinical benefit is modest and the effects are not durable, the regulatory process for the drug is likely to be wrought with noise, controversy over the next 12-18 months.”
The separate late-stage trial in June had raised similar concerns about how long the symptom improvement effects would last. The new trial results have again hit the same notes making it a hard sell for Sage Therapeutics.
Depression drug in the U.S.
Every year, around 16 million American adults are affected with major depressive disorder. This is mostly cured with antidepressants that take six weeks to show effect.
Sage Therapeutics has already had a postpartum depression drug on the market. The company plans to seek U.S. approval this year. It has already signed a deal for $1.5 billion with Biogen to develop Zuranolone and another experimental drug.
Zuranolone has been more successful in decreasing the symptoms than placebo after three days. The difference was lower than the expectations questioning the lasting effects of the drug.
However, the officials from Sage Therapeutics added that the drug remains approvable and had expected to wane over time as the company has decided to evaluate the results at day three for the main goal instead of at day fifteen (as in the June trial).