Marinus Pharmaceuticals, a Pennsylvania-based biotech company, is taking decisive action in response to recent challenges faced during a phase 3 clinical trial, including significant workforce reduction and other cost-saving measures.
The company’s decision to lay off approximately 20% of its staff comes in the aftermath of disappointing results from the RAISE trial, which evaluated intravenous ganaxolone as a treatment for refractory status epilepticus (RSE). Following an interim analysis that did not meet predefined stopping criteria, Marinus Pharmaceuticals CEO Scott Braunstein, M.D., signaled the need for evaluating potential cost-saving strategies in April.
In addition to reducing its workforce, Marinus Pharmaceuticals is deferring investments in manufacturing intravenous ganaxolone and halting enrollment in both the RAISE trial and another late-stage study called RAISE II. The company plans to assess future development in RSE based on a review of the RAISE trial’s topline data.
To further optimize its financial position, Marinus Pharmaceuticals will implement additional cost reductions across its research and development (R&D) and general and administrative functions. The company aims to increase overall efficiency by making operational changes while maintaining a focus on its core objectives.
Despite these setbacks, Marinus Pharmaceuticals remains financially stable, with $113.3 million in cash and equivalents as of March. With the implemented cost-saving measures, the company expects to sustain operations until the first quarter of 2025, ensuring continued progress in the commercialization and development of ganaxolone. This compound, marketed under the brand Ztalmy, has been approved for the treatment of seizures associated with the rare genetic condition CDKL5 deficiency disorder (CDD) and is also being evaluated in the late-stage TrustTSC trial.
As Marinus Pharmaceuticals navigates through this challenging period, its commitment to advancing innovative therapies for neurological disorders remains unwavering. The company’s strategic focus on optimizing resources and prioritizing key initiatives underscores its determination to overcome obstacles and deliver meaningful advancements in patient care.
