StockMarketWire.com - Mereo BioPharma Group said it had gathered positive data from a safety extension study to a clinical trial for a treatment of hypogonadotropic hypogonadism in men.

The treatment, BGS-649, was a once-weekly oral aromatase inhibitor designed to restore a patient's own testosterone to normal levels.

The company had previously reported positive headline efficacy data from a phase 2b clinical trial in March 2018.

The safety extension study enrolled 143 patients, with 88 patients completing the additional six months of treatment.

It did result in a pre-specified reduction in bone mineral density at 48 weeks following the initial 24 weeks treatment.

The study was successful in demonstrating that none of the doses of BGS-649 met the lower boundary of the pre-specified safety criterion of a greater than 3% reduction in lumbar spine BMD after 48 weeks of treatment.

Consistent with this finding, none of the doses of BGS-649 met the secondary safety endpoint criterion of a greater than 3% reduction in bone mineral density in the hip.

In addition, there was no shift into clinical categories of osteopenia or osteoporosis, with no evidence of development of new osteopenia.

'We are pleased that the results of our six-month extension study reiterate the positive top-line results we announced earlier this year,' chief executive Denise Scots-Knight said.

'The extension data provides further evidence of the potential of BPS-649.'

'Following further data analysis in the first half of 2019 we will confirm our plans for the late stage clinical development of this promising drug as we also consider potential partnerships.'





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