Metabolic reports successful phase I trials

Melbourne biopharma Metabolic (ASX:MBP) has announced plans to take its ACV1 conotoxin analgesic into phase IIa clinical trial in volunteers with chronic neuropathic pain next year.

Metabolic announced today that its phase I single- and multiple-dose trials in humans had confirmed that the novel drug, a peptide from the venom of an Australian Conus cone shell species, was safe and well tolerated.

"I am pleased to say this study was performed on schedule and with successful outcomes." said Metabolic CEO Dr Roland Scollay in a statement. "ACV1 was shown to have a very good tolerability profile in phase 1 over the full dose range tested and this is a very pleasing result."

There was no evidence of adverse effects, except for transient, mild local skin reactions at the injection side. Pharmacokinetic data showed the drug diffused through the bloodstream at a time and rate predicted from animal studies.

ACV1 caused no numbing of normal sensation, or blunting of normally painful stimuli in the healthy subjects, indicating that it specifically reversed the abnormal sensitivity in pain-sensing nerves called C-fibers, which resulted in sensations of burning or aching.

Scollay said the drug was exciting interest from overseas pharmaceutical companies and specialty biotechs.

The company is designing protocols for the phase IIa trial, in collaboration with Australian and US experts, and the trial would begin as soon as supplies of the drug could be produced, and ethics committee approval had been secured.

According to Metabolic chronic neuropathic pain affects 1 to 3 per cent of the population. It results from mechanical injury to nerves, or from diseases like diabetes, or viral infections like herpes and HIV. The pain may be severe, and debilitating.

Current drugs provided relief in only 50 per cent of cases, and the current global market for drugs to treat chronic neuropathic pain was around US$2.5 billion, increasing to $5.5 billion by the end of the decade.