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Mereo BioPharma Hails Positive BGS-649 Phase II Clinical Trial Data

Mon, 19th Mar 2018 13:14

LONDON (Alliance News) - Mereo BioPharma Group PLC said Monday it had received positive top-line data for its phase II clinical trial for hypogonadotropic hypogonadism in obese men.

Mereo said its phase IIb dose-ranging study with BGS-649 had met its primary endpoint with over 75% of its patients experiencing normalised total testosterone levels after 24 weeks of treatment.

It also achieved its secondary endpoint of normalising testosterone levels in 90% of patients after 24 weeks. This occurred at the two highest doses, Mereo added.

All three dose levels, however, reached their other secondary endpoints. These included improvement in testosterone luteinising hormone and follicle stimulating hormone levels.

BGS-649 is a once weekly oral aromatase inhibitor. It is designed to restore testosterone to normal levels by inhibiting the conversion of testosterone to oestradiol.

Mereo Chief Executive Officer Denise Scots-Knight said: "We are delighted with the results from the primary and secondary endpoints of this study which we believe further demonstrate the potential of BGS-649 to become an important new and convenient treatment option for the more than 12 million obese men in the US and EU suffering from HH. We are particularly encouraged by the ability of BGS-649 to improve LH and FSH levels, one of the major limitations of current therapies."

"We look forward to the results from the BGS-649 six-month safety extension study expected in the fourth quarter of 2018," Scots-Knight added. "These will be combined with further detailed analysis of the current data to further inform our understanding of the exploratory PROs and how to most appropriately incorporate them into our developing clinical strategy for BGS-649 going forward."

Shares in Mereo were 1.6% higher at 310.00 pence on Monday.

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