VistaGen Therapeutics VTGN announced disappointing results from a mid-stage study, ELEVATE, on pipeline candidate, AV-101.
AV-101 is an NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, which is being evaluated as an adjunctive treatment of major depressive disorder (MDD).
The ELEVATE study was a phase II, double-blind, placebo-controlled, multi-center, sequential parallel comparison design study that evaluated the safety, tolerability and efficacy of AV-101 as an adjunctive treatment in patients with MDD, who had an inadequate response to a stable dose of standard antidepressant therapy (either a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor).
The data showed that the AV-101 treatment arm did not differentiate from placebo on the primary endpoint (change in the Montgomery-Åsberg Depression Rating Scale (MADRS-10) total score compared to baseline).
Nevertheless, VistaGen will continue to examine the full dataset from this study to evaluate the effects on other endpoints and pharmacokinetics. The company will also consider the upcoming results from a target engagement study and the potential impact of compelling new evidence from recent preclinical studies.
Shares crashed 71.9% on the results. Shares of the company have plunged 80% so far this year against the industry’s growth of 1.4%.
VistaGen, a clinical-stage biopharmaceutical company, is developing differentiated new generation medications for central nervous system (CNS) diseases and disorders with high unmet need.
The pipeline includes three differentiated clinical-stage candidates — AV-101, PH10 and PH94B. Apart from MDD, AV-101 is also being evaluated as a non-opioid treatment for chronic neuropathic pain and an oral therapy for dyskinesia associated with levodopa therapy for Parkinson’s disease and suicidal ideation. PH94B is being evaluated for social and other anxiety disorders and PH10 for MDD.
Sage Therapeutics SAGE is also evaluating SAGE-217 as a rapid-acting, durable, short-course treatment for MDD.
Earlier this year, Alkermes ALKS received a Complete Response Letter from the FDA regarding its New Drug Application for ALKS 5461 for the adjunctive treatment of MDD.
Zacks Rank & Another Key Pick
VistaGen currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the biotech sector is Anika Therapeutics Inc. ANIK, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased to $2.03 from $1.75 for 2019 in the past 30 days.
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