Bone upbeat after trial results

The ambitions of Bone Medical (ASX:BNE) to bring the first oral version of osteoporosis drug calcitonin to the world market moved closer today, when the company announced encouraging results from a Phase I/IIa study of its lead candidate BN002.

A sequential clinical trial of seven subjects, undertaken by clinical research organisation Richmond Pharmacology in the UK, showed BN002 was biologically active, achieving reductions of up to 40 per cent in bone breakdown, a statistically significant result, according to Bone's chief operating officer John Fitzgerald. Bone recently announced that a Phase I trial of BN002 showed it was safe and well tolerated.

In the Phase I/IIa study, nasal calcitonin was administered, followed by Bone's oral calcitonin. Blood levels of calcitonin, calcium and telopeptide -- a marker of bone destruction -- were recorded for each version of the drug.

Fitzgerald said the purpose of the study -- to determine the drug's pharmacokinetic profile -- had been achieved. "We now know that the formulation and delivery system is working well, now we look at the formulation to see whether we can tweak that. [BN002] was slower than the nasal formulation," he said. Bone is planning a full Phase II human clinical trial -- providing further data on dosing, formulation and efficacy -- although the timing and location of this trial are yet to be decided. "We would hope to be back into the clinic this calendar year, but certainly by the first quarter of next," said Fitzgerald. "I would hope that it would be run here in Australia."

Because injectable and intranasal formulations of calcitonin have been on the market for 25 years, Bone is pursuing a bioequivalence registration, which means that Phase III trials are unlikely to be required.

All-important regulatory approvals are next on the company's to-do list, with Bone planning to approach US and European authorities with the results from its trials to date.