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news.Inflazyme Pharmaceuticals and Helicon Therapeutics have obtained positive results from phase I clinical studies with IPL455,903, indicating the drug to be safe and well tolerated at all doses tested, with no serious adverse events noted.
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IPL455,903 (or HT-0712) is a phosphodiesterase-4 (PDE4) inhibitor being developed by Helicon compound for the treatment of learning and memory disorders.
The initial phase I studies were designed to assess the safety, tolerability and pharmacokinetic properties of an escalating, single oral dose of IPL455,903 in 50 healthy volunteers aged 18-81.
Results showed that there was no evidence of nausea or vomiting (emesis). To date, other PDE4 inhibitors have frequently been observed to cause nausea and emesis even after a single dose of the drug has been administered, contributing to an unacceptable safety profile which has hampered their progress in clinical development.
In addition to showing that the drug appeared to be safe and well tolerated, the studies also indicated that IPL455,903 demonstrated acceptable pharmacokinetic properties.
“We are pleased with these results,” said Dr Kevin Mullane, CEO of Inflazyme. “This adds to our confidence that we may have developed proprietary PDE4 inhibitors which lack emetic activity. We will now focus some of our activities to leverage this novel chemical series in disease areas outside of learning and memory disorders.”
Helicon will be continuing the phase I program with additional double blind, placebo controlled, multi-doses of IPL455,903 in volunteers treated for two weeks. These studies will expand on the single dose studies by investigating further the safety, tolerability and pharmacokinetic properties of the compound.