Biotechnology company VistaGen Therapeutics has concluded its final Phase I study evaluating the safety of AV-101, a prodrug candidate for multiple applications including chronic neuropathic pain.
The oral prodrug AV-101 (L-4-chlorokynurenine) demonstrated a good safety profile, in addition to encouraging bioavailability and pharmacokinetics (PK), and was well-tolerated in the randomised, double-blind study.
VistaGen chief executive officer Shawn Singh said confirmation of AV-101’s safety and tolerability is the final step in the Phase I programme.
"With $8.8 million of funding from the National Institutes of Health (NIH) and outstanding strategic development and regulatory support from Cato Research Ltd., we have successfully completed the required studies enabling Phase II clinical development of AV-101 for multiple large market neurological diseases and conditions," Singh said.
"In addition, recent data from the NIH suggest that the same neural pathway modified by AV-101 may be useful for treating depression."
The placebo-controlled, dose-escalation trial was conducted at the University of California, San Diego (UCSD).
The primary objectives of the study were to estimate the safety, tolerability and PK of three varied daily doses of the drug against placebo.
Oral administration of the prodrug was observed to be safe and well-tolerated at all three dose levels when tested on healthy volunteers.
UCSD, department of anaesthesiology, pain medicine division chair and principal investigator of the study Mark Wallace said the Phase I programme met the primary safety and tolerability endpoints and that the compound was safe with no observed side effects.
"AV-101 is an exciting prodrug compound that acts through a promising mechanism to treat pain. I am excited to move this compound into Phase II studies for the treatment of pain, " Wallace said.
VistaGen expects to further advance development and commercialisation of AV-101 in 2013 through a strategic collaboration.