Mereo BioPharma posts positive top-line from latest BGS-649 study

Biopharmaceutical company Mereo BioPharma Group announced positive top-line results from a phase 2b dose-ranging study with BGS-649 for the treatment of hypogonadotropic hypogonadism (HH) in men with a body mass index of over 30 on Monday.

The AIM-traded firm described BGS-649 as a once weekly oral aromatase inhibitor designed to restore a patient's own testosterone to normal levels by inhibiting the conversion of testosterone to oestradiol.

It said the study met its primary endpoint, normalising total testosterone levels in over 75% of subjects after 24 weeks of treatment, and its secondary endpoint of normalising testosterone in at least 90% of patients after 24 weeks, which occurred at the two highest doses.

All three doses met all the other secondary endpoints, including the improvement of testosterone luteinising hormone (LH) and follicle stimulating hormone (FSH) levels.

The study demonstrated a clear dose response in both the primary and secondary endpoints, the Mereo board claimed.

It added that the exploratory endpoint of improvement in total motile sperm count was also met.

A positive trend of treatment effect was also observed on reduction of fatigue in the exploratory patient reported outcomes (PROs) of the PROMIS short fatigue score.

“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,” said Mereo CEO Dr Denise Scots-Knight.

“We are particularly encouraged by the ability of BGS-649 to improve LH and FSH levels, one of the major limitations of current therapies.”

Scots-Knight said the company “looked forward” to the results from the BGS-649 six-month safety extension study expected in the fourth quarter of 2018.

“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.”