Marinus Pharmaceuticals has laid off approximately 45% of its employees following the failure of a Phase III trial for its drug ganaxolone in treating seizures associated with tuberous sclerosis complex (TSC). The company announced the workforce reduction as part of a cost-cutting measure after the disappointing trial results.
TrustTSC Trial Fails to Meet Primary Endpoint
The Phase III TrustTSC trial evaluated oral ganaxolone for the treatment of seizures associated with TSC. However, the trial did not meet its primary endpoint, which was the percent change in 28-day seizure frequency. As a result, Marinus has decided to discontinue further clinical development of the oral formulation of the drug.
In a statement, the company said it is exploring strategic alternatives to maximize value for stockholders. This includes a Type C meeting with the FDA later this quarter to discuss a potential path forward for intravenous ganaxolone in refractory status epilepticus.
Financial Impact and Strategic Alternatives
Marinus reported a net loss of $24.2 million for the third quarter of 2024 and $98.7 million for the nine months ended September 30, 2024. As of September 30, 2024, the company had $42.2 million in cash and cash equivalents. Marinus expects these funds to be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2025.
Prior to this layoff, Marinus had already reduced its workforce by approximately 20% in May. With the additional cuts, the company is estimated to have around 73 employees remaining, down from 165 at the end of 2023.
Ganaxolone's Potential in Refractory Status Epilepticus
Despite the setback with the oral formulation, Marinus is still pursuing the development of intravenous ganaxolone for refractory status epilepticus. Results from a Phase III trial in June showed that the drug met one of its primary endpoints, demonstrating rapid cessation of status epilepticus in a highly refractory patient population. However, it failed to achieve statistical significance on the other primary endpoint, which was the proportion of patients not progressing to intravenous anesthesia.
