Phase 2 trial of VistaGen Therapeutics' AV-101 in major depression disorder after its main point of loss, launching shares in the nanocap marketplace down 64% down. VistaGen answered the failure of the ketamine drug line by giving a vote to review all the details before it makes a decision on the next steps.
The expectations of the degree were deception in May when a trial of AV-101 was sponsored by an investigator that the opposition of NMDA glucose site is ineffective in depression as monotherapy. VistaGen pointed out that the differences between the designs of the two were very much against reading too much, but eventually the online take-aways were similar.
In the most recent introduction, VistaGen found that AV-101 was no better than placebo improving scores on the MADRS-10 depression scale, leaving the main point of the study. VistaGen is not yet sharing data from the 199-subject study, but there is an unequivocal failure of the qualitative understanding.
"The intensive study of the study tells us that AV-101, at the concentrations used, was not effective," said Maurizio Fava, Massachusetts General Hospital, in the study's principal investigator, in a statement.
However, VistaGen is still to comply with AV-101. CEO Shawn Singh mentioned the possibility that AV-101 failed to cross the blood-brain barrier in sufficient quantities or that too much of the active metabolite could have a future accrual of the target tissue. If these reasons explain the failure, VistaGen feels that AV-101 combined with probenecid anion transport inhibitor could help.
Singh and her colleagues plan to review clinical and clinical data on AV-101 in a handful of signs in 2020 before deciding whether further studies will be carried out. The lack of psychotropic side effects or serious adverse events in phase 2 means that admissibility is unlikely to hinder further development.
VistaGen wants to make progress with other programs as it relates to AV-101. PH94B nasal spray is to enter stage 3 in social anxiety disorder and PH10 is moving into phase 2 in major depression disorder.
Another issue is whether VistaGen can plan all its planned activities. VistaGen completed September with $ 4.1 million in cash and cash equivalents. With phase 2 failure driving VistaGen share price down under $ 1, the ability of biotechnology to collect money is restricted.
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