Sage Therapeutics has scored another big win in the clinic. SAGE-217 triggered near-immediate, fairly durable improvements in patients with major depressive disorder (MDD), sending its stock on a tear for the second time in the past month.
The phase 2 looked at the effect of the positive allosteric modulator of the gamma-aminobutyric acid (GABA) receptor as compared to placebo in 89 patients with MDD.
Investigators saw a statistically significant improvement in SAGE-217 patients on a depression scale the day after the first dose. By the time the two-week treatment period came to an end, the mean score in the SAGE-217 arm had dropped 17.6 points, as compared to a 10.7 point decline in the control group. That seven-point placebo-adjusted improvement was enough for the trial to hit its primary endpoint with a p value of less than 0.0001.
Almost two-thirds of subjects in the treatment arm were in remission on day 15. The remission rate in the placebo group fell short of 25%.
The positive results continued beyond the end of the treatment period. The mean reduction on the depression scale in the treatment arm remained statistically superior to that of the placebo group two weeks after dosing stopped, although by that point the gap had closed to less than four points. By six weeks, the gap was down to two points, too little to achieve statistical significance.
Sage saw the same pattern in the remission rates, with statistical outperformance fading to just numerical superiority between the fourth and sixth week of the trial.
No patients suffered serious adverse events in the trial and the overall rate of adverse events was comparable between the two arms. Two patients on SAGE-217 dropped out. All patients on placebo completed the trial.
The data make SAGE-217 a rare example of an oral drug that has moved the needle in a midphase depression trial. Caveats will remain until Sage shows whether it can repeat the trick in a larger trial. But for now, the company is riding high as a biotech with a wholly-owned, seemingly effective CNS drug.
Shares in Sage shot up as much as 69% in premarket trading. The jump comes weeks after Sage’s share price went through the roof on the back of data on SAGE-547 in postpartum depression. Those back-to-back gains mean Sage has more than recovered from the failure of its seizure drug.
The next step is to prepare for further development of SAGE-217.
“The positive activity and safety findings of SAGE-217 in MDD support advancing the program into later stage clinical development and we will work with the FDA to determine next steps in the further development of SAGE-217,” Sage CEO Jeff Jonas, M.D., said in a statement.