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Marinus Pharmaceuticals Provides Business Update and 2015 Financial Results

RADNOR, Pa., March 07, 2016 (GLOBE NEWSWIRE) -- Marinus Pharmaceuticals, Inc. (MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update on its clinical development activities and reported its financial results for the year ended December 31, 2015.

Recent Clinical & Corporate Highlights:

  • Completed enrollment in pivotal Phase 3 clinical trial in adults with drug-resistant focal onset seizures
  • Completed requisite preclinical studies and manufacturing activities in preparation for ganaxolone IV clinical studies
  • Expanded clinical and regulatory management team
  • Closed public equity financing with gross proceeds of $30.0 million
  • Fully enrolled exploratory Phase 2 clinical trial in PCDH19 pediatric epilepsy and completed treatment in exploratory Phase 2 clinical trial in Fragile X Syndrome (FXS)

“During 2015 we made considerable progress in advancing the development of our CNS-selective GABAA modulator, ganaxolone, paving the way for several significant clinical milestones in 2016,” said Christopher M. Cashman, Chief Executive Officer of Marinus Pharmaceuticals. “With enrollment complete in our first pivotal Phase 3 clinical trial in drug-resistant focal onset seizures and the addition of our ganaxolone IV dose form, 2016 has the potential to be a transformative year for Marinus. Looking ahead, we believe that the next twelve months offer an opportunity for the company to validate the significant potential of our ganaxolone franchise in treating multiple high-need medical conditions.”

During the fourth quarter of 2015, we achieved a number of key milestones that were important in advancing our corporate mission, including:

Pipeline Highlights

  • Completed patient recruitment in our first pivotal Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset seizures. The Company is on-track to announce top-line results in mid-2016.
  • Completed treatment in the exploratory Phase 2, investigator-sponsored clinical trial of ganaxolone in children with FXS. The primary objective of the study is to assess the safety, tolerability and efficacy of ganaxolone for treatment of anxiety and attention in subjects with FXS. Nine rating scales are being used to assess outcome measures for specific behaviors associated with childhood FXS. The Company plans to announce top-line results in the first half of 2016.
  • Completed patient enrollment in the exploratory Phase 2 clinical trial of ganaxolone in PCDH19 pediatric epilepsy. Patients enrolled in the study are undergoing six-months of treatment following a twelve-week baseline period. The Company plans to announce full data in mid-2016.

Corporate Highlights

  • Completed a public equity financing with gross proceeds of $30.0 million. Existing and new healthcare-dedicated institutional investors led the financing, which provides the Company with sufficient capital to evaluate ganaxolone IV in human clinical trials.
  • Bolstered clinical and regulatory expertise in preparation of expanding the global Phase 3 programs with the appointment of Jaakko Lappalainen, M.D., Ph.D., as VP of Clinical Operations and Kimberly A...

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