The last patient-out milestone was reached on
The C301 study assessing the therapeutic value of estetrol (E4) in post-menopause is a crucial component for the company's submissions in both
Mithra remains dedicated to pioneering medical advancements, and the positive developments in the C301 study underscore our commitment to delivering innovative solutions that address critical healthcare needs.
In addition to the success of the C301 study, Mithra also announces the approval of the competent authorities and ethics committees for all protocols for its clinical program extension to explore treatments beyond VMS in post-menopausal women. The clinical program extension encompasses various studies focusing on dermatological and reproductive health, including the following: Skin Study - A single-centered, randomized, double-blind, placebo-controlled proof of concept study in
Hair Study - A single-centered randomized, double blind, placebo-controlled proof of concept study in
FSAD Study - A multicentric, randomized, double-blind, placebo-controlled proof-of-concept study conducted in
Graham Dixon, Chief Scientific Officer of Mithra, commented, 'These projects highlight Mithra's commitment to demonstrate beneficial effects of E4 on other bothersome symptoms of menopause beyond VMS. The European study (C301) should reinforce the differentiated safety profile of E4, supporting further the broad therapeutic potential of this molecule. As Mithra manages its business challenges, the R&D team remains focused on supporting our estetrol platform to ensure that patients have access to our differentiated therapeutics. The advancements announced today showcase Mithra's resilience and determination in navigating the complex landscape of clinical research, further solidifying its position as a leader in
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