Marinus to cut workforce and explore options after Ztalmy trial setback

Marinus Pharmaceuticals, a pharmaceutical company, has been dealt a blow after its Seizure drug, Ztalmy, did not reach the primary endpoint in the phase three trial for its treatment of seizures that result in Tuberous Sclerosis Complex. This is the second major trial failure this year for Ztalmy, meaning Marinus is pulling the plug on further development of the drug in TSC.

The trial conducted called TrustTSC failed to meet the statistical measure, something that can be seen by the fact that Ztalmy recorded a median seizure reduction of 19.7% while the placebos recorded only 10.2%. Still, the results did not reach statistical significance that would allow Ztalmy to file a supplemental new drug application (sNDA) with the FDA.
In its recent quarterly report, Marinus’ CEO Scott Braunstein, M.D. stated that while the trial results provide informative data on how ganaxolone, Ztalmy’s active pharmaceutical ingredient, acts when it is administered together with other known treatment therapies including mTOR inhibitors, cannabidiol and others, the information generated is not enough to file for approval.
As for this most recent trial miss, Marinus is ceasing all further Ztalmy development for TSC and, in the process, is promising to cut costs, including laying off workers. The company has also sought the services of Barclays to help the firm search for “strategic opportunities” that will improve the shareholder’s value. Marinus will, therefore, continue to support Ztalmy’s commercial availability for this approved use in treating CDKL5 deficiency disorder, a rare seizure disorder, with over 200 patients currently using the same.
This reverse is coming after an earlier disappointing trial in the first half of this year where an intravenous version of Ztalmy only achieved one of two key goals in a trial for the treatment of refractory status epilepticus (RSE), a serious, chronic and prolonged seizure disorder. This partial success occurred only days after a class action lawsuit had been filed on behalf of Marinus shareholders charging securities fraud or other unlawful conduct. However, Marinus still wants to THINK about the RSE indication, and it has expressed intentions of plans on meeting FDA about next steps.

The sales of Ztalmy were $8M in the second quarter, and that is 87% more than it in the same period of the previous year. The New Jersey-based drugmaker sees full-year sales of Xermelo in the range of $33M to $35M, which it anticipates will support operations till the second quarter of 2025. This past June, the company’s cash balance was $64.7M; the company stated that the amount would suffice its requirements in the near future. Failure in the latest trial significantly affects the future prospects of the drug as per Marinus’ strategic vision but Ztalmy continues to endorse the approved indication and look at long-term possibilities.

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