The Company remains completely blinded to the data from this analysis.
BGS-649 is a novel once weekly oral aromatase inhibitor in development as a first-line therapy for the treatment of obese men with hypogonadotropic hypogonadism (HH). It is currently being investigated in a Phase 2b clinical study in 268 HH patients with a body mass index (BMI) of more than 30.
This study compares three doses of BGS-649 with placebo.
The interim analysis was performed once the first 93 patients had completed at least one month’s treatment. In addition to safety, the efficacy analysis assessed if each dose was likely to normalise testosterone in at least 75% of patients, the primary endpoint, over the six months course of treatment.
Based on the review of the data, the IDMC has recommended that all three arms should continue versus placebo until patients have received the full six months of treatment.
At the end of the initial treatment period, patients have the option to enrol into a six month safety extension study in which they will receive the same dose or in the case of placebo patients they will be randomised to one of the three doses.
To date there have been no trends that raise safety concerns including all patients enrolled into the initial six month study. Results from the Phase 2b study are expected to be announced during the second half of 2017.
Mereo Biopharma Group CEO Dr Denise Scots-Knight said: “We are delighted the IDMC has recommended that all three doses continue to be tested in the ongoing Phase 2b trial for BGS-649. We believe this drug has the potential to become a novel and effective treatment option for obese men suffering from hypogonadotropic hypogonadism.
“We are encouraged by the number of patients who have already enrolled into the six month safety extension study and look forward to announcing the headline results of the Phase 2b study in H2 2017.”
The primary objective of this Phase 2b study is to demonstrate the efficacy of BGS-649 to normalise total testosterone levels in greater than 75% of subjects after 24 weeks of treatment. The Company is also assessing patient recorded outcomes and determining the impact of BGS-649 on the levels of LH and FSH and on semen parameters.
The Company has also initiated a six-month Phase 2b extension study for BGS-649 to confirm the safety of long-term treatment. This study aims to enrol up to 120 patients from the initial six month BGS-649 study and will include monitoring of testosterone levels and any changes in bone parameters.
In previous clinical studies with Novartis, BGS-649 was shown to normalise testosterone levels, increase LH and FSH and was safe and well tolerated in men with HH with an average body mass index (BMI) of 34. These data will be presented as a late breaker poster at the Endo 2017 meeting on 2 April in Orlando.