BioWorld International Correspondent

LONDON - CeNeS Pharmaceuticals plc announced positive results in the first Phase III trial of M6G, showing the morphine metabolite is an effective analgesic for post-operative pain and confirming the effective dose of the drug.

Neil Clark, chief operating officer, told BioWorld International, “We set out in this clinical trial to show we have got a painkiller as effective as morphine, and this was proved, so we are very pleased.”

Cambridge-based CeNeS now is planning a final European Phase III study. It expects to complete it in 2005 and make an initial European product filing in 2006. Clark said CeNeS will be ready to start the trial early in 2005, but will not do so until it has enough money to finance it, either through an equity funding or a partnering deal.

While he would prefer an equity funding, Clark also is exploring possible collaborations.

“We have talked previously to potential partners, and hope the quality of these results will renew their interest,” he said. CeNeS had £6.1 million (US$10.9 million) in cash at the end of June.

Although the Phase III trial was not designed to compare M6G’s side effect profile with that of morphine, it did support Phase II studies that showed M6G caused less nausea and vomiting. “All secondary outcomes would be pointless unless we have got an effective painkilling agent, and this is what the trial demonstrated,” Clark said, adding that “this increases confidence in the Phase II data and should lead to a significant up-rating in the value of this M6G asset.”

The study, in 167 patients suffering post-operative pain following knee-replacement surgery under spinal anesthesia, was designed to pave the way for a placebo-controlled study comparing the side effect profile of M6G vs. morphine.

The primary measure was the amount of morphine patients self-administered in the 12 hours following treatment with an effective dose of M6G. The results showed a statistically significant reduction of morphine consumption by patient-controlled analgesia. A single dose of M6G was effective for more than 12 hours and up to 24 hours, and equivalent pain control was observed in all study groups. In addition, there were positive trends in secondary outcome measures such as reduced nausea and vomiting.

The final European Phase III study, in patients suffering moderate to severe post-operative pain following surgery carried out under a general anesthetic, will compare M6G and patient-administered analgesia vs. morphine and patient-administered analgesia. The endpoints will be analgesic efficacy and side effect profile of M6G vs. morphine.

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