Sage Therapeutics Ends SAGE-324 Collaboration with Biogen

Sage Therapeutics, Inc., a biopharmaceutical company based in Cambridge, Massachusetts, announced that Biogen has ended its collaboration with Sage concerning the SAGE-324 program. This decision follows the recent unfavorable results from the Phase 2 KINETIC 2 Study, which evaluated the efficacy of SAGE-324 for chronic treatment of essential tremor (ET). The study's disappointing outcomes led to the cessation of further clinical development of SAGE-324 for ET.

Despite this setback, Sage and Biogen will maintain their partnership on ZURZUVAE® (zuranolone), the pioneering FDA-approved oral medication specifically designed for the treatment of postpartum depression (PPD) in women. This ongoing collaboration underscores their mutual commitment to addressing the needs of women affected by PPD.

The termination of Biogen's rights under the collaboration and license agreement will take effect on February 17, 2025. At that point, Sage will regain full ownership of the SAGE-324 asset. Sage plans to continue exploring other possible applications for SAGE-324 beyond essential tremor.

ZURZUVAE, known chemically as zuranolone, is a neuroactive steroid that modulates the gamma-aminobutyric acid A (GABA A) receptor. It is indicated for the treatment of postpartum depression in adults. However, it is important to note that ZURZUVAE can cause significant side effects, including drowsiness, dizziness, fatigue, and urinary tract infections. Patients are advised to avoid driving or operating heavy machinery for at least 12 hours after taking each dose due to the risk of decreased alertness and increased likelihood of falls. Additionally, combining ZURZUVAE with alcohol, CNS depressants, or opioids can exacerbate these side effects and potentially cause breathing difficulties. The medication is classified as a controlled substance (C-IV) because it contains zuranolone, which has the potential for abuse or dependence. Patients should inform their healthcare providers if they become pregnant or plan to become pregnant during treatment and use effective contraception during and for one week post-treatment. ZURZUVAE is not approved for use in children and may increase the risk of suicidal thoughts and actions in individuals 24 years of age and younger.

SAGE-324 is an investigational oral neuroactive steroid and GABA A receptor positive allosteric modulator (PAM). These modulators work by enhancing the inhibitory activity of the GABAergic system, the primary inhibitory neurotransmission system in the brain, playing a crucial role in maintaining balanced neuronal activity. The safety and effectiveness of SAGE-324 remain unproven.

Sage Therapeutics, founded in 2010, is dedicated to developing innovative brain health medicines. The company has successfully brought to market the only two FDA-approved treatments for postpartum depression and continues to advance a robust pipeline aimed at addressing various unmet needs in brain health.

In summary, while the discontinuation of the SAGE-324 program represents a significant development, Sage Therapeutics remains focused on its mission to improve brain health through innovative treatments like ZURZUVAE for postpartum depression. The company is poised to continue exploring potential new indications for SAGE-324 and other investigational therapies in its pipeline.