Sage Therapeutics to Provide Update on Key 2019 Initiatives at J.P. Morgan Healthcare Conference
– Multi-franchise strategy ongoing in depression, neurology and neuropsychiatry –
– Commercial infrastructure build completed for ZULRESSO™
(brexanolone) injection ahead of
– Statistically significant results achieved in Phase 3 trial of SAGE-217 in postpartum depression –
– First patient dosed in second pivotal trial of SAGE-217 in major depressive disorder –
“We’ve made significant progress over the last eight years and our
innovative approach to discovery and development has resulted in five
consecutive positive trials in mood disorders,” said
Dr. Jonas will discuss the following milestones anticipated in the next 12-18 months:
Led by ZULRESSO™(brexanolone) injection, which has been designated as a breakthrough therapy by the
Buildout of the commercial infrastructure to support the potential
launch of ZULRESSO for the treatment of PPD is complete.
FDArecently extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for ZULRESSO in the treatment of PPD.
December 19, 2018PDUFA goal date was extended by a period of three months to March 19, 2019; launch of ZULRESSO in the U.S., if approved, will follow the anticipated scheduling of brexanolone by the Drug Enforcement Administration(DEA), and is projected for June 2019.
- Previously disclosed
- Commercial activities, if the NDA is approved, will focus on executing across key pillars of the go-to-market strategy by enabling Centers of Excellence while identifying patient access and reimbursement pathways to optimize the patient experience.
Statistically significant topline results from the Phase 3 ROBIN Study
of SAGE-217 in severe PPD patients demonstrated a rapid, profound and
sustained reduction in depressive symptoms compared to placebo.
- After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression (HAMD-17) score, compared to 13.6 for placebo (p=0.0029).
- Remission was achieved in 45 percent of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23 percent of patients receiving placebo (p=0.0122), with a remission maintained through the end of the 4-week follow-up.
- Results from secondary endpoints were statistically significant and consistent with the primary endpoint.
- SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Two subjects experienced serious adverse events (SAEs), one subject in each group. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). The most common adverse events (>5%) in either treatment group were somnolence (12.8% SAGE-217; 8.2% placebo), headache (9.0% SAGE-217; 12.3% placebo), dizziness (7.7% SAGE-217; 5.5% placebo), upper respiratory tract infection (7.7% SAGE-217; 1.4% placebo), diarrhea (6.4% SAGE-217; 2.7% placebo), nausea (3.8% SAGE-217; 8.2% placebo), sedation (5.1% SAGE-217; 0.0% placebo), vomiting (1.3% SAGE-217; 5.5% placebo), abnormal dreams (0.0% SAGE-217; 5.5% placebo) and hyperhidrosis (0.0% SAGE-217; 5.5% placebo).
Additional topline results in the pivotal program for SAGE-217 in MDD
anticipated in 2020:
Phase 3 MOUNTAIN Study in patients with MDD;
- First patient dosed in Q4 2018
- Phase 3 RAINFOREST Study in patients with MDD and co-morbid insomnia;
- Phase 3 SHORELINE Study evaluating SAGE-217 open-label treatment, treatment-free intervals and as-needed retreatment for return of major depressive episodes.
- Phase 3 MOUNTAIN Study in patients with MDD;
- Data from Part A open-label portion of the Phase 2 ARCHWAY Study of SAGE-217 in patients with bipolar depression expected in 1H 2019.
Led by SAGE-324, a next-generation positive allosteric modulator (PAM) of GABAA receptors
Phase 1 studies ongoing with further clinical development to be
explored for neurological conditions, including essential tremor and
- Phase 1 multiple ascending dose (MAD) trial evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic profile of SAGE-324 ongoing.
- Phase 1 single ascending dose (SAD) trial of SAGE-324 in healthy volunteers recently completed.
- Topline results from the Phase 1 SAD and MAD studies expected in 1H 2019.
- Plan to initiate a Phase 1 open-label study in 1H 2019 to determine the safety, tolerability and pharmacokinetics of SAGE-324 in approximately 10 patients with essential tremor. Topline results are anticipated in 2H 2019.
Led by first-in-class NMDA receptor PAM, SAGE-718
First-in-class NMDA receptor PAM being explored in certain
cognition-related disorders impacted by NMDA receptor dysfunction
currently in Phase 1 development. The healthy volunteer portions of
the Phase 1 SAD and MAD trials are complete.
- Initiated target engagement biomarker studies in healthy volunteers, focusing on electrophysiology and imaging, to further evaluate SAGE-718. Results of these Phase 1 healthy volunteer studies, including SAD, MAD and the target engagement studies, are anticipated in 1H 2019.
- Initiated a Phase 1 double-blind, placebo-controlled MAD study to determine the safety, tolerability and pharmacokinetics of SAGE-718 in approximately 10 patients with early manifest Huntington’s disease. Topline results are anticipated in 2H 2019.
Webcast Information for J.P. Morgan Healthcare Conference Presentation
Sage is scheduled to present at the 37th Annual
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation statements regarding: our expectations regarding the possible approval of our NDA filing for ZULRESSO™ (brexanolone) injection,including the target timing of a decision by the
Maureen L. Suda