MITHRA TO INITIATE PK STUDY FOR ESTELLE®
* First step toward bringing Estelle® to the Japanese and ASEAN markets with partner Fuji Pharma
* Bridging study aims to characterize and compare the pharmacokinetic (PK) profile of Estetrol(E4)and its combination with Drospirenone (DRSP) in Japanese and Caucasian subjects
Liège, Belgium May 12, 2017 - 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, CEO 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