Bayer has started a Phase III ASTEROID clinical programme of vilaprisan with enrolment of the first patient for treatment of uterine fibroids.
Vilaprisan is Bayer’s oral, selective progesterone receptor modulator (SPRM) being developed to provide long-term treatment of uterine fibroids and endometriosis.
The ASTEROID Phase III programme is designed to evaluate the efficacy and safety of 2mg vilaprisan in multiple clinical trials involving symptomatic uterine fibroid patients.
Estimated to be performed over a period of three years, the programme will recruit more than 3,600 subjects at up to 900 sites in around 40 countries.
Bayer Development head and Pharmaceutical division executive committee member Dr Joerg Moeller said: "Based on the promising results we have seen with vilaprisan in the Phase II clinical study programme, we are very excited about the start of the Phase III trials that aims for a new symptom control for symptomatic uterine fibroids in a long-term treatment option.
“It is our ambitious goal that our research efforts in this field result in a medical therapy that controls symptoms and thereby significantly improves the quality of life for women with uterine fibroids.”
The ASTEROID Phase II clinical study programme conducted in patients suffering from symptomatic uterine fibroids had been the base for the determination of dosing regimen and design of Phase III programme.
The Phase II programme included a Phase IIb ASTEROID 1 trial that compared the efficacy and safety of four doses of vilaprisan to placebo and another Phase IIb ASTEROID 2 trial that assessed the efficacy and safety of vilaprisan as compared to placebo and ulipristal acetate (Esmya).