Publication date: 30/11/2017
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces an update on the clinical study progress for its two lead Estetrol (E4) based product candidates, Estelle® (E4 Freedom) and Donesta® (E4 Relief).
Estelle®, Mithra’s novel contraceptive product candidate composed of 15 mg of Estetrol (E4) and 3 mg of drospirenone (DRSP), is currently in Phase III studies in Europe/Russia and in the US/Canada. Recruitment has now been completed for both studies and currently over 50% of subjects have completed more than half of the 13 treatment cycles. Moreover, 20% have completed the full 13 cycles and the end of study visit in the European arm of the study, and over 4% of subjects in the US study. Results for the Europe/Russia and US/Canada studies are on track to report top line data in Q3 2018 and Q1 2019, respectively.
Recruitment has also been completed for Donesta® which is currently in a Phase IIb dose-finding study for menopausal symptoms with E4 alone. At this stage, almost 80% of the 260 subjects have successfully finished the 12-week protocol with close to 60% of women having completed the additional end of study visit. Top-line results are expected towards the end of Q1 2018.
François Fornieri, CEO of Mithra, commented:
“We are pleased with the excellent progress made in our E4 clinical studies. This could be an indication of the good user acceptability of Donesta® and Estellle®, which may prove to be an important benefit for these novel product candidates. We are looking forward to the results of the studies, which have the potential to indicate that Estelle® and Donesta® offer a safer, efficient alternative to currently marketed products in contraception and menopause.”
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO.
Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com