Sweden-based Diamyd Medical has announced that the Phase 2 study of NP2 Enkephalin failed to meet the primary objective of reducing pain in subjects with severe intractable cancer pain.
An initial data analysis from the 28 day, double-blind, main study period shows that from day three to day 14, following a single dose of the study drug, the group that received NP2 Enkephalin reported on average no better improvement in pain score than the placebo-treated group.
Diamyd Medical president and CEO, Peter Zerhouni, said that although the company had hoped for a better outcome regarding pain relief in the study, the treatment appeared safe, which is an important finding for the whole NTDDS platform.
"We will continue our analysis of this study, including subgroups and the data from the open-label extension period, to determine how to adapt the development plan for our NTDDS portfolio of drug candidates addressing diseases and symptoms within the nervous system which today cannot be adequately treated," Zerhouni added.
The randomised, double-blind study was conducted to evaluate the effect of intradermal injections of NP2 Enkephalin on pain reported by subjects suffering from severe intractable pain due to cancer, as well as to confirm the safety of the treatment.
According to the company, data continues to be collected from an open-label extension period of the study, in which subjects received up to two additional doses of NP2 Enkephalin.
In addition, all subjects will receive conventional pain therapy throughout the study, including opiate drugs.
The treatment was well tolerated, confirming the safety of the company's NTDDS technology.
President of Diamyd, the US subsidiary of Diamyd Medical, Darren Wolfe, said: "That the technology appears safe in this trial will expand our development options and other indications may prove better targets for this therapeutic approach, be it with NP2 Enkephalin or other drug candidates from our NTDDS platform."