VistaGen Announces Positive Results of Newly Published Exploratory Phase 2a Study of PH10 for Rapid-Onset Treatment of Major Depressive Disorder
SOUTH SAN FRANCISCO, Calif., Feb. 20, 2020 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet medical need, today announced positive results from a newly published exploratory Phase 2a clinical study of PH10, its investigational first-in-class, rapid-onset synthetic neurosteroid nasal spray, for treatment of major depressive disorder (MDD). Results of the double-blind, randomized, placebo-controlled Phase 2a study have been published in the peer-reviewed British Journal of Pharmaceutical and Medical Research.
In the single-site exploratory Phase 2a study (n=30), randomized participants received placebo or either a 3.2 µg or a 6.4 µg dose of PH10 neuroactive nasal spray twice daily for eight weeks. Change in total score on the 17-item Hamilton Depression Rating Scale (HAM-D-17), a multiple-item questionnaire used to provide an indication of depression as a guide to evaluate recovery, was measured at the end of each week of treatment. A rapid antidepressant benefit from the PH10 6.4 µg dose was evidenced by changes in HAM-D-17 scores at the end of the first week of treatment. After one week of treatment, the mean reduction of HAM-D-17 scores for the PH10 6.4 µg group was 10.1 points, which was statistically greater (p = 0.03) than the mean reduction in the placebo group of 4.2 points from baseline. Also, at the end of the last week of treatment (Week 8), the PH10 6.4 µg group showed a mean HAM-D-17 score reduction of 17.8, which was statistically greater than the mean reduction in the placebo group of 10.9 points from baseline (p = 0.02). Thus, in the PH10 6.4 µg treatment group, the HAM-D-17 score improved significantly from the baseline within one week and this effect was sustained until the Week 8 study endpoint. Notably, both the PH10 3.2 µg and 6.4 µg treatment groups showed strong effect sizes after one week of treatment (0.72 for the 3.2 µg dose and 1.01 for the 6.4 µg dose) and at the Week 8 study endpoint (0.74 for the 3.2 µg dose and 0.95 for the 6.4 µg dose).
There were no reports of serious adverse events. At the end of treatment, all subjects reported to have tolerated twice daily self-administration. The results of this peer-reviewed published study suggest PH10's potential as a non-systemic, rapid-onset, new generation antidepressant for the millions of people suffering from depression around the world. VistaGen is currently preparing for Phase 2b clinical development of PH10 in the U.S. for treatment of MDD.
"The results of this exploratory Phase 2a clinical study demonstrate PH10's exciting potential to treat patients with MDD with a first-in-class, non-systemic, rapid-onset antidepressant without the serious psychological side effects and safety concerns of ketamine-based therapy. The large separation from placebo seen at one week, the first time point measured, and sustained through eight-week completion is very encouraging. The significant reduction in HAM-D-17 with the 6.4 µg dose at the end of the first week of treatment suggests that the antidepressant effect of PH10 may have started even earlier than 1 week. Our plan for Phase 2b development of PH10 in MDD includes a next-step study of four weeks in duration, with an earlier initial measurement of antidepressant effect, likely within the first 24 to 48 hours of initial dose administration," stated Mark Smith, M.D., Ph.D., Chief Medical Officer of VistaGen.
"Depression remains a highly prevalent and difficult to treat mental illness, but we believe these data suggest a new path forward in providing treatment for the millions of individuals with MDD. The significant reduction in HAM-D-17 scores for the PH10 6.4 µg group versus the placebo group not only offers evidence of PH10's potential to be a fast-acting, easily administered MDD treatment alternative, but also supports the nasal chemosensory system as a novel way of delivering CNS active medications, which is also relevant for VistaGen's other neuroactive nasal spray, PH94B for social anxiety disorder entering Phase 3 development later this year," added Dr. Smith.
View original content to download multimedia:http://www.prnewswire.com/news-releases/vistagen-announces-positive-results-of-newly-published-exploratory-phase-2a-study-of-ph10-for-rapid-onset-treatment-of-major-depressive-disorder-301008346.html
SOURCE VistaGen Therapeutics
Company Codes: NASDAQ-SMALL:VTGN