AIKO Biotechnology, Inc. completed the second Phase I human clinical trial of AIKO-150, the lead compound in its portfolio of opioid antagonists designed to improve pain therapy. This trial demonstrated that AIKO-150 does not interfere with pain relief in healthy subjects at doses which prevent the gastro-intestinal slowing (i.e. constipation) associated with opioid use.
According to Wolfgang Sadee, Chief Scientific Officer. “This second trial has confirmed the high potency of AIKO-150 in selectively improving bowel motility while not interfering with pain relief.
Confirming findings from the first Phase I trial, these results, combined with high tolerability and safety, support development of AIKO-150 as a drug meeting an urgent clinical need, with outstanding commercial potential.”
AIKO’s Second Exploratory Phase I trial was designed to demonstrate that AIKO-150 does not interfere with pain relief in healthy subjects, is safe, and peripherally selective. Four increasing doses of AIKO-150 were administered to healthy subjects who were also administered morphine. Results showed:
• Extremely high potency in blocking opioid GI effects with no interference of opioid-induced pain relief.
• No significant adverse effects.
• Dose-proportional pharmacokinetics.
According to AIKO President, Bill Emhiser, “The second trial completed under the FDA’s Exploratory IND mechanism confirmed the prediction that AIKO-150 does not interfere with pain relief while preventing GI slowing. There is a large and well defined market for indications such as opioid-induced constipation, and I think the commercial potential for AIKO-150 is exceptional.”
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.:
AIKO Biotechnology, Inc. (“AIKO”) is a 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 opioid-induced bowel dysfunction, addiction and abuse.
