Mithra, a company dedicated to women's health, announces that the company received IRB approval for the launch of a PK ethnobridging study for Estelle. Estelle is Mithra's novel oral contraceptive product candidate composed of 15 mg E4, its unique native estrogen, and 3 mg DRSP. Currently, pivotal phase III Estelle trials are ongoing in the US and Canada as well as in Europe and Russia.
Mithra announced its partnership with Fuji Pharma for the development of Estelle in Japan and ASEAN in August 2016. Top line results of the study are expected between Q4 2017 and Q1 2018.
The study is a single-center, double-blind, placebo-controlled, randomized trial to compare the pharmacokinetic (PK) profile of different dosages of E4 combined with DRSP or E4 alone between Japanese and Caucasian subjects. In total, 96 participants will be recruited, 48 of which will be Japanese and 48 Caucasian. The women will be randomized over four treatment groups.
The primary objective is to determine and compare the PK profile after a single oral dose, by charting differences in drug exposure and elimination. Additionally, safety and tolerability of E4 and DRSP, and of E4 alone, will be evaluated in the study population.
François Fornieri, chief executive officer Mithra Pharmaceuticals: "We are pleased to start the bridging study with our partner, Fuji Pharma. Progressing development to this stage highlights the constructive collaboration with Fuji Pharma, as well as their commitment to the Estelle program. Moreover, this is an essential first step towards bringing Estelle to the Japanese market, and to potentially offer a safer contraceptive alternative to millions of Japanese women."