Microcap biotech VistaGen turned to pennystock after PhII results show its depression drug doesn't work solo
VistaGen Therapeutics’ AV-101 has flunked an exploratory Phase II, quashing hopes that the drug could work as a monotherapy for treatment-resistant depression.
To be sure, these are tough to treat patients: On average the 19 patients enrolled in the study had tried 7.8 different antidepressants over their lifetime to treat their TRD, which has lasted an average of 8.6 years.
After waning these patients off their antidepressants, investigators administered either AV-101 or placebo for 14 days, then following a wash out period swapped the drug and placebo arms. At the end, the drug did not induce a significant change from baseline in the Hamilton Depression Rating Scale — the primary endpoint.
Nevertheless, VistaGen $VSTN said the trial (sponsored by and conducted at the National Institute of Mental Health) confirmed the safety profile of their drug, which they are continuing to test. Topline results from the other study are expected later this year.
“In contrast to the NIMH study, our ongoing ELEVATE study is designed to evaluate AV-101 as a novel adjunctive therapy in a significantly different population of MDD patients, namely those whose current depressive episode is less than 2 years,” CEO Shawn Singh said.
Investors don’t seem as patient. VistaGen’s share price, which was hovering above $1, plunged 44% Thursday following the announcement, throwing the microcap biotech into pennystock territory.