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Marinus Pharmaceuticals (MRNS) just released positive results from its Phase 2 clinical trials, which evaluated ganaxolone intravenous (IV) (called the Magnolia Study) and oral (the AmaryllisStudy) for women with postpartum depression (PPD). The results prompted the company to advance both studies to the next phase. Marinus shares reacted to the news, soaring as much as 16% in Monday’s trading session.
Data from the Magnolia Study showed a clear dose-response relationship for three groups of patients who all received ganaxolone IV. Results of patients using the medication compared to placebo showed a mean HAM-D17 reduction of 16.9 versus 4.2 points measured from the baseline at 60 hours and 15.7 versus 4.1 placebo at day 34. 75% of patients were responders, which is defined as having less than 50% reduction from the baseline by day 34 and 67% were responders at 60 hours.
Bassem Maximos, MD, MPH, FACOG, and a Principal Investigator in the Magnolia Study, commented on the experiment:
“The impressive safety profile and antidepressant effect demonstrated in these women marks an important advancement in the development of treatment of PPD. With no cure or approved treatment for the one in seven women suffering from PPD, there is a great need for potential treatment options that are safe, fast-acting and convenient. I look forward to working with Marinus as they continue to develop both the IV and oral formulations of ganaxolone,” Maximos said.
The Amaryllis Study revealed information about Oral Ganaxolone during its Phase 2 clinical trial, which was hosted to evaluate the safety, tolerability and efficacy of oral ganaxolone for women with PPD. Similarly to IV, oral ganaxolone was generally safe and well-tolerated with no serious adverse events reported and no discontinuations due to treatment related adverse events.
Chief Executive Officer of Marinus, Christopher M. Cashman expounded on the results:
“Reporting these data from both of our PPD studies is an important milestone for Marinus. Based upon these encouraging results, we are now equipped to enroll patients into the next phase of development where we can explore more convenient IV and oral dosing regimens. Ganaxolone’s efficacy and clean safety profile provides the opportunity to develop a fast acting, durable and convenient treatment regimen to meet the needs of moms suffering from postpartum depression,” Cashman noted.
More data is expected to be revealed in the first half of 2019. Marinus plans to publish the full set of data from the Magnolia study at a future medical conference.
TipRanks points to high confidence from the Street in the last 12-months on this biotech player, with all 4 analysts polled bullish on Marinus stock. The 12-month average price target stands at $18.25, marking a solid upside of nearly 270% from where the stock is currently trading. (See MRNS’s price targets and analyst ratings on TipRanks)