PORTLAND, ME, OCTOBER 19, 2009. AIKO Biotechnology, Inc. completed the first Phase I human clinical trial of AIKO-150, the lead compound in its portfolio.
According to AIKO President, Bill Emhiser, “Using the FDA’s Exploratory IND mechanism, AIKO was able to conduct this Phase I trial to confirm the prediction that AIKO-150 will reverse opioid-induced constipation at dosages that do not precipitate withdrawal in a highly sensitive population. This is in stark contrast to conventional opioid antagonists such as naloxone that trigger withdrawal at extremely low doses in opioid-dependent subjects. We believe this trial validates the superiority of AIKO’s patented neutral antagonists to treat a broad array of opioid-induced side effects. More specifically, this trial substantiated high potential for co-formulation of AIKO-150 with an opioid to create an abuse-resistant pain reliever without the GI side effects associated with opioid use.”
This trial demonstrated the mechanism of action of AIKO-150, showing for the first time in humans that neutral antagonists do not precipitate severe withdrawal reactions in opioid-dependent subjects at dosage levels that relieve the gastro-intestinal slowing associated with opioid use.
AIKO’s Exploratory Phase I trial was designed to demonstrate that AIKO-150 acts as a neutral antagonist in humans, exhibiting high potency for relief of opioid-induced gastro-intestinal slowing while being less potent for precipitating opioid withdrawal. Four increasing doses of AIKO-150 were administered to methadone-dependent subjects. Results showed: • Extremely high potency for decreasing GI transit time. • Significant abdominal distress at high doses, without significant scores for objective or subjective withdrawal measures. • Dose-proportional pharmacokinetics, similar to those expected from published studies of AIKO-150 as a human metabolite of naltrexone. “The results of this trial are very encouraging and we hope to complete a second Exploratory Phase 1 trial in the near future,” according to Wolfgang Sadee, Chief Scientific Officer.
AIKO-150 is AIKO’s lead compound in its portfolio of naltrexone/naloxone analogs, such as naltrexol, naltrexamine, naloxol and their derivatives, shown to be neutral at the mu opioid receptor (patent 6713488). Support for this trial was provided, in part, by a Development Award from the Maine Technology Institute. About AIKO Biotechnology, Inc.: Contact - Janet Yancey-Wrona, jyancey@aikobiotech.com, 207.317.0960 AIKO Biotechnology, Inc. (“AIKO”) is a start-up biotechnology company located in Portland, ME focused on the discovery and validation of novel compounds for the treatment of pain and the side effects associated with prescription pain reliever (opioid) use, such as GI dysfunction, addiction and abuse.
