Sage and Biogen claimed that their investigational drug Zuranolone is a potential breakthrough in the management of depression
Sage, Biogen unveil positive results for Zuranolone. (Credit: VSRao from Pixabay.)
Sage Therapeutics and Biogen announced that their Zuranolone 50mg has met its primary endpoint in the Phase 3 WATERFALL trial in patients with major depressive disorder (MDD).
Zuranolone showed statistically significant improvement in depressive symptoms compared to placebo, within 15 days, as measured by the Hamilton Rating Scale for Depression (HAMD-17) score.
The Phase 3 WATERFALL trial evaluated the efficacy and safety of the 50mg drug in MDD patients aged 18 to 64 years, with HAMD-17 total score equal to or above 24.
In the trial, Zuranolone was generally well-tolerated and showed a safety profile consistent with previous clinical studies.
The drug has received the US Food & Drug Administration Breakthrough Therapy Designation (BTD) and the companies are planning to discuss further steps with the agency.
Sage Therapeutics CEO Barry Greene said: “Sage’s expertise in the modulation of the GABA receptor pathway in the brain, coupled with insights on the treatment wants and needs of clinicians and patients, has resulted in our targeting a unique benefit/risk profile with the development of Zuranolone supported to date by the data generated in the WATERFALL Study and the broader Landscape and NEST programmes.
“We dared to imagine a different future for the treatment of MDD where patients have the potential to experience a rapid response that is well-tolerated and that may enable them to stay better with long periods free from depression symptoms, and free from daily chronic treatments and related side effects.
“In doing so, we aspire to help eliminate stigma associated with brain health disorders so that we can move beyond brain health awareness to brain health action.”
For the past 60 years, daily administered monoamine-based antidepressants have been the standard of care for the treatment of chronic MDD.
The traditional antidepressants would require adequate exposure and continuous use to maintain the therapeutic effect.
Zuranolone is a synthetic, orally active, inhibitory pregnane neurosteroid, administered orally once daily for every two weeks for rapid-acting, sustainable treatment of MDD.
Sage and Biogen claimed that their investigational drug is a potential breakthrough in the management of depression.
Biogen R&D head Alfred Sandrock said: “Together with our collaboration partners at Sage, we are proud to announce highly encouraging results from the Phase 3 WATERFALL Study of Zuranolone in major depressive disorder.
“These results represent hope and positive progress for the more than 250 million patients worldwide who are estimated to live with depression. Major depressive disorder is a common co-morbidity of many diseases represented in Biogen’s neuroscience portfolio.
“We believe Zuranolone has the potential to offer a unique, first-in-class therapeutic for depression with a distinct benefit-risk profile to people living with this common but serious mental health condition.”
Biogen, together with partner Eisai, has received the US FDA accelerated approval for Aduhelm (aducanumab-avwa) to treat a type of Alzheimer’s disease.