- Important milestone for Mithra’s commitment to bring benefits of ESTELLE® to more women
- Potential EMA approval in pediatric population could lead to six-month extension of the Supplementary Protection Certificate (SPC)1 and hence extended patent exclusivity
- Study recruited more than 100 adolescents, with primary aim to evaluate safety profile
- Last subject, last visit now completed, with data expected in Q2 2024
Liege, Belgium, 20 December 2023 – 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of a pediatric study of its marketed contraceptive ESTELLE® in adolescent women.
The study (MIT-Es001-C303, ClinicalTrials.gov: NCT04792385, EudraCT: 2019-003002-27) evaluates the safety, compliance, and pharmacokinetic profile of ESTELLE® in more than 100 participants aged 12 to 17 years old. The primary endpoint of the study, which is being conducted in Estonia, Finland, Georgia, Latvia, Poland and Sweden, is to evaluate the safety of ESTELLE® in post-menarchal subjects. Recruitment was completed in April 2023 and the last subject and last visit has now been held, with data expected to be available in Q2 2024.
Graham Dixon, Chief Scientific Officer of Mithra, commented, “The completion of this pediatric study on schedule is another important milestone for Mithra. It underlines our commitment to bringing the benefits of ESTELLE® to a broader patient population, as we continue to work to demonstrate its differentiated safety profile. With results from this study expected in Q2 2024, we are taking another step towards potentially offering ESTELLE®’s differentiated efficacy, safety, and convenience to additional female populations, effectively expanding our reach.”
Combined oral contraceptives such as ESTELLE®, Mithra’s first product based on estetrol (E4) naturally-occuring estrogen, are the most popular hormonal contraceptives2 in the adolescent population. Adolescents are more likely than adult women to use these products for health purposes other than birth control such as cycle and bleeding control3. Despite widespread use in adolescents, clinical data from this population is limited.
Mithra is undertaking this study under a Pediatric Investigation Plan (PIP) agreed with the European Medicines Agency (EMA). Medicines which are authorized by the EMA, with the application include results from studies conducted under a PIP, are eligible for an extension of their SPC by six months.
1 Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right