Mereo to continue testing inhibitor for certain obese men with all three dosesMarch 7, 2017
Mereo BioPharma said on Tuesday that the Independent Data Monitoring Committee (IDMC) has recommended the continuation of all three different dose arms of the Phase 2b BGS-649 study following a prospectively defined interim analysis of safety and efficacy. The company said it remains completely blinded to the data from this analysis.
Currently in phase 2b clinical study, BGS-649 is a once weekly oral aromatase inhibitor in development as a first-line therapy for the treatment of obese men with hypogonadotropic hypogonadism (HH). This study compares three doses of BGS-649 with placebo.
The interim analysis was done as the first 93 patients had finished at least one month’s treatment. The IDMC has recommended that all three arms should continue versus placebo until patients have received the full six months of treatment.
Mereo noted that the Phase 2b study results should be available in the second half of 2017.
“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,” said Dr Denise Scots-Knight, Chief Executive Officer of Mereo Biopharma Group.