Marinus lays off a fifth of its workforce amidst epilepsy woes

2024-05-08

临床3期上市批准

Marinus Pharmaceuticals said Wednesday it will cut about 20% of its staff and halt a Phase III trial of its experimental epilepsy treatment, less than a month after a disappointing clinical update for ganaxolone in a separate study sent shares of the biotech plummeting.

In April, an IV formulation of the GABA receptor modulator failed to meet early stopping criteria in the Phase III RAISE study in patients with refractory status epilepticus (RSE).

The wait for topline results, which are due this summer, may be straining the biotech’s budget. Marinus has about $113.3 million on-hand, which was originally intended to only fund operations through the fourth quarter of this year. Wednesday’s cost-cutting moves are expected to extend its cash runway, but only into the first quarter of 2025.

In addition to the workforce reduction and the discontinuation of the RAISE II trial – a second Phase III study of ganaxolone in RSE, designed to help support European approval – Marinus will defer IV ganaxolone manufacturing investments and undertake additional cost reductions across both its R&D and administrative departments.

The company said it will instead focus on the development of oral ganaxolone to treat tuberous sclerosis. The Phase III TrustTSC trial is expected to report topline data in the fourth quarter; if positive, Marinus plans to submit a regulatory application with the FDA in April 2025, and expects a priority review.

Marinus is also hoping for an uptick in sales of its sole marketed programme Ztalmy, an oral version of ganaxolone approved by the FDA in 2022 to treat seizures associated with CDKL5 deficiency disorder CDKL5 deficiency disorder. The drug brought in $7.5 million in revenue during the first quarter, and Marinus is projecting full-year sales between $33 and $35 million, having previously estimated sales in the range of $32 to $34 million.

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