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Trust favourite Sage to test ‘217 in treatment resistant depression

FDA fast track review for trust-backed Sage Therapeutics

Trust favourite Sage to test ‘217 in treatment resistant depression  – US biotech Sage Therapeutics announced plans to advance its lead development candidate, SAGE-217 (zuranolone) into a Phase III trial for treatment-resistant depression (TRD). The drug is already in Phase III for major depressive disorder (MDD) and has completed – successfully – a Phase III trial in post-partum depression (PPD). Sage, which has seen its stock price double so far this year, is the fourth largest holding of Switzerland’s BB Biotech (BBB), at 6.5% of NAV, and is also known to be a smaller holding of International Biotechnology Trust (IBT).

Analysts see the move as a relatively high-risk move as TRD is by definition the most difficult sub-type to treat and only one drug is approved (J&J’s Spravato). The move provides a back-up plan if the ongoing “Mountain” Phase III study in MDD fails; results are due from this study at the end of this year or early next.

Sage developed the IV postpartum depression drug Zulresso, while the orally administered SAGE-217 is expected to become its successor, especially after the failure of the a phase II study of Marinus’ oral version of ganaxolone in this same indication just two days ago.

Sage also reported results of the Archway Phase II study of SAGE-217 in bipolar disorder (BPD).The open-label single-arm study enrolled 35 BPD subjects and showed a MADRS reduction of 15.5 points on day 15 which was maintained out to day 42. The company plans to conduct a blinded trial at a future date before further investment in this indication. .

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