ObsEva’s Oral Treatment for Uterine Fibroids Nails Phase III

An oral drug developed by the Swiss company ObsEva was shown to reduce menstrual bleeding and pain caused by uterine fibroids.

The phase III trial tested ObsEva’s drug candidate linzagolix in 535 women suffering from heavy menstrual bleeding caused by benign tumors in the uterus called uterine fibroids. The effects of the drug were compared to those of a placebo both with and without hormonal add-back therapy, which is used to prevent hot flashes, a common side effect of uterine fibroid medication.

After six months of taking linzagolix once per day, 94% of patients given the highest dose of the drug with hormonal add-back therapy had reduced their menstrual bleeding by half, compared to just 29% of those receiving a placebo. Patients also experienced significantly less pain and a better quality of life than those taking the placebo.

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Linzagolix blocks the action of gonadotropin-releasing hormone, which is involved in the regulation of the menstrual cycle. This mechanism of action is designed to avoid an initial flaring of symptoms caused by currently available drugs to treat uterine fibroids. In addition, the drug candidate can be given orally instead of through injection.

ObsEva is also running a phase III trial of the same drug in the US, with results expected in mid-2020. If all goes to plan, ObsEva aims to apply for market approval in the EU by the end of 2020.  

At present, there is another competitor drug treatment for uterine fibroids in phase III trials. This is relugolix, developed by the UK company Myovant. Like linzagolix, Myovant’s drug is an oral blocker of gonadotropin-releasing hormone given once per day. It produced positive results in a phase III trial for the treatment of uterine fibroids earlier this year, and Myovant expects to apply for FDA approval at the end of this year. 


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