Clinical Trials Arena

Marinus parts ways with 20% of its workforce

Marinus expects to share data from the Phase III RAISE trial of IV ganaxolone for the treatment of status epilepticus later in the summer.

Marinus Pharmaceuticals has announced that it is sacking approximately 20% of its workforce as a part of the company’s plans to reduce operating costs that will allow for the advancement of the company’s “near-term goals.”

The reorganisation efforts come a month after the company’s pivotal RAISE study (NCT04391569), which is evaluating IV ganaxolone for the treatment of status epilepticus (SE), failed to meet its pre-defined early stopping criteria. The company said it plans to run the trial to completion to determine the next steps of drug development, and will release topline results in the summer.

As per the 8 May Q1 financial results and business update, the cost reduction plan, which has already been implemented, will allow Marinus to retain the necessary staff to evaluate topline results from the RAISE study and advance any future development of the treatment. The actions are expected to extend Marinus’ cash runway—which as of 31 March equates to $113.3m—late into Q1 2025.

In other cost reduction activities, the Radnor, Pennsylvania-based pharmaceutical company reported that it has terminated clinical trial enrollment for the Phase III RAISE and RAISE II trials for refractory status epilepticus, as well as deferred manufacturing investments for IV ganaxolone.

Marinus will allocate its resources toward the development and commercialisation of the oral administration formulation of ganaxolone, which is on the market under the brand name Ztalmy as an anti-seizure medication for the treatment of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Ztalmy, which first received US Food and Drug Administration (FDA) approval as a treatment for CDKL5 deficiency disorder in March 2022, was awarded UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for use in the same indication in March 2024. According to the press announcement, the drug generated net product revenues of $7.5m in Q1 2024. Marinus anticipates that the full year net product revenues for Ztalmy will now amount to $33-35m.

According to GlobalData’s consensus forecasts, Ztalmy is anticipated to generate global sales of $263m in 2029. GlobalData is the parent company of Clinical Trials Arena.

Marinus is also conducting a global Phase III TrustTSC study studying the drug as a treatment for tuberous sclerosis complex. “We are optimistic that we can replicate the success of our pivotal CDD trial of ZTALMY in the TrustTSC study, where we believe refinements made to the Phase III titration schedule and low discontinuation rates throughout the trial suggest improved tolerability,” said CMO Dr. Joseph Hulihan.