Sage Therapeutics will reduce its workforce by 40% following the US Food and Drug Administration’s (FDA) rejection of its drug Zurzuvae (zuranolone) in adults with major depressive disorder (MDD).

The US-based company will pause some undisclosed early-stage programs and focus instead on the refinement of its compounds SAGE-718 and SAGE-324, per the 31 August announcement. Sage’s leadership will also change with the departure of the current chief scientific officer (CSO) Al Robichaud and the chief development officer (CDO) Jim Doherty.

The restructuring comes at a time when the company plans the commercial launch of Zurzuvae for treating postpartum depression which is expected in late 2023. On 4 August, the FDA approved Zurzuvae’s use in women with postpartum depression while simultaneously issuing a complete response letter (CRL) for the treatment’s use in MDD. The CRL stated that the drug’s application did not provide substantial evidence of effectiveness in MDD and that further studies are needed.

The drug’s approval in postpartum depression was based on the NEST program, which included the Phase III ROBIN (NCT02978326) and SKYLARK (NCT04442503) studies. Both trials met their primary endpoints. Zurzuvae is a neuroactive steroid GABA-A receptor positive allosteric modulator. The GABA system is the major signalling pathway in the brain and central nervous system and contributes to regulating brain function, based on the company’s website.

According to consensus forecasts from GlobalData’s Pharma Intelligence Centre, Zurzuvae can earn an estimated to earn $2.94bn in global sales in 2029. GlobalData is the parent company of Pharmaceutical Technology.

Soon after the approval, the company stated that it was evaluating resource allocation options, which included pipeline prioritisation and workforce reorganisation to stretch out its cash runway, per an announcement from the time.

Sage has a global collaboration agreement with Biogen for the development of Zurzuvae, and SAGE-324, which is being explored in indications such as essential tremors, epileptiform disorders, and Parkinson’s disease.

As part of the agreement, Biogen and Sage split responsibilities and costs for the development and commercialisation of the treatments in the US, while Biogen is responsible for the those functions abroad, except for Zurzuvae’s development in Japan, South Korea, and Taiwan.

Sage has an existing collaboration agreement with Shionogi that gave the Japanese company the right for all clinical development, regulatory filings, and commercialisation of Zurzuvae in these three countries, from 2018.

https://www.pharmaceutical-technology.com/news/sage-therapeutics-fires-40-of-staff-after-fda-rejected-mdd-bid/