After a series of mid-stage clinical trial failures, Sage Therapeutics has announced that it will jettison 165 employees, which totals 55% of its R&D team and 33% of its entire workforce.
As per the 17 October press release, the move was made in a bid to strengthen the company’s financial and long-term operational positions while having the flexibility to tackle its immediate priorities. The restructuring, which is expected to be largely complete by the year’s end, is anticipated to incur a cost of $26–28m in Q4 2024.
The reorganisation is also intended to allocate available resources towards continuing to support the commercial launch of Zurzuvae (zuranolone), a neuroactive steroid (NAS) gamma-aminobutyric acid type A (GABA-A) receptor-positive allosteric modulator designed to regulate mood and behavior. The small molecule therapy, jointly developed by Sage and Biogen, became the first US Food and Drug Administration (FDA)-approved oral treatment for postpartum depression in August 2023.
Since its commercial launch in December 2023, Zurzuvae generated $6.2m and $7.4m in Q1 and Q2 2024, respectively. According to GlobalData’s consensus forecasts, Zurzuvae is expected to generate total sales of $607m in 2030. GlobalData is the parent company of Pharmaceutical Technology.
Zurzuvae was also previously studied in major depressive disorder (MDD). However, along with its approval in postpartum depression, the FDA issued a complete response letter (CRL) stating that the drug did not demonstrate substantial evidence of effectiveness in MDD and that further studies were needed. Following the FDA’s rejection of Zurzuvae in MDD, Sage slashed its workforce by 40% to refocus its business priorities.
Sage has navigated choppy waters of late. Earlier this month, the company announced that its positive allosteric modulator of the NMDA receptor dalzanemdor failed to demonstrate superiority to placebo in the Phase II LIGHTWAVE (NCT05619692) study. The study evaluated the effects of dalzanemdor on cognitive performance in participants with Alzheimer’s disease. Based on data from LIGHTWAVE, Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s.
The Alzheimer’s trial news means that dalzanemdor has had two successive clinical failures. The candidate was also previously evaluated for the treatment of Parkinson’s disease. However, after failing the Phase II PRECEDENT study (NCT05318937), Sage pulled the plug on development in this indication.
The biopharma’s remaining hopes for dalzanemdor rest on data from its Phase II DIMENSION study (NCT05107128) for the treatment of Huntington’s disease. Data from this study is expected by late 2024.
