Mereo BioPharma on Tuesday presented positive data after testing BGS-649, oral inhibitor aromatase treatment of hypogonadotropic hypogonadism (HH) for obese men.
In the study which enroled 143 men with a body mass index of over 30, BGS-649 was given once weekly, with aim to restore a patient’s own testosterone to normal levels by inhibiting the conversion of testosterone to oestradiol.
Mereo said this study result was consistent with the top-line data announced in March 2018, as treatment with BGS-649 normalized total testosterone levels in over 75% people. All doses met all other secondary endpoints so far, including the improvement of testosterone luteinising hormone (LH) and follicle stimulating hormone (FSH) levels, Mereo said.
The adverse event profile in the extension study, where all patients received one of the three doses of BGS-649 for 6 months was similar to that seen in patients receiving the drug in the placebo controlled portion of the trial. There was an increased incidence of raised haematocrit levels in patients receiving BGS-649 and small increases in blood pressure at the two highest doses consistent with increasing testosterone.
Dr. Denise Scots-Knight, Chief Executive Officer of Mereo said:
“We are pleased that the results of our six-month extension study reiterate the positive top-line results we announced earlier this year. The extension data provides further evidence of the potential of BPS-649. Following further data analysis in 1H 2019 we will confirm our plans for the late stage clinical development of this promising drug as we also consider potential partnerships.”