Freya Pharma Solutions Announces Appointment of Dr. Jan van der Mooren as Chief Medical Officer, to guide its pivotal phase 3 clinical trial with Lybrido against FSIAD

Dr. van der Mooren brings three decades of experience in clinical trials

AMSTERDAM, April 12, 2022 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women who have been diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the appointment of Jan van der Mooren MD, PhD, MSc (picture below) as Chief Medical Officer as per April 2022. Dr. Van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology. He has been involved in clinical research since 1990. Prior to his appointment he was Senior Director of the Danone Nutricia Research Center in Utrecht, the Netherlands. Jan will be in the lead of Freya's steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.

Marcel Wijma, Executive Director at Freya Pharma Solutions said:

"We are very pleased to have Jan join our leadership team as we are on the brink of commencing our phase 3 clinical trial with our promising compound Lybrido, against FSIAD. His depth of experience in clinical trials and knowledge in the field of Gynaecological Endocrinology will be especially valuable during this pivotal time at the company."

Dr. Van der Mooren brings to Freya three decades of life sciences experience in clinical development and medical affairs in nutrition, epidemiology, obstetrics and gynaecology. Most recently he served as Senior Director R&I Governance, Communication & Excellence and Senior Director of the Nutricia Research Center in Utrecht. Prior to that he held several leading R&D positions within the Danone and Numico organisations, heading the Clinical Research in early life nutrition, advanced medical nutrition, fresh dairy products and waters since 2005. From 1995 until 2005 he was Associate Professor, Epidemiologist and project leader of  "Ageing Women" at the Department of Obstetrics & Gynaecology of VU University Medical Center in Amsterdam. In addition to several other functions, he was Senior Researcher and Project Co-ordinator of the "Postmenopause Project" at Radboud University Hospital in Nijmegen, the Netherlands.

Dr. Jan van der Mooren, newly appointed CMO at Freya commented:

"I am excited to be joining Freya and look forward to working with the outstanding leadership team here in the pivotal trial phase of the company's promising solution for millions of women worldwide who are coping with FSIAD, resulting in lower health-related quality of life, including more depressive symptoms, and lower sexual and relationship satisfaction."

Upcoming pivotal phase 3 trial

Freya Pharma Solutions plans to conduct the pivotal phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD. Previous pre-clinical and clinical studies, manufacturing and development of Lybrido were performed according to EU GLP, GMP and GCP regulations.

It is anticipated that a Scientific Advice Meeting with the EMA will be held before commencement of the phase 3 trial. The main objective of that meeting would be to confirm acceptability of the phase 3 clinical trial design, as well as the overall clinical development strategy. The phase 3 clinical trial will be conducted within the European Union in accordance with Good Clinical Practices and the ethical principles stated in the Declaration of Helsinki. It will comply with the EU Clinical Trial Regulation (No. 536/2014), all other applicable laws and regulations, as well as requirements of applicable Member States where the study is undertaken.

About FSIAD

Low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.

About Lybrido

A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (Lybrido) and women with dysfunctional over-activation of sexual inhibition (Lybridos). Lybrido increases central sexual motivation and physiological sexual responses, such as swelling of vaginal erectile tissue and lubrication. The therapy can be taken 'on demand' and helps to increase central sexual motivation from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingual testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.

About Freya Pharma Solutions

Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized 'on demand' solution for this recognized unmet medical need.

Please contact for further information:

Freya Pharma Solutions, Amsterdam
Marcel Wijma, Executive Director
marcel@freyapharmasolutions.com

For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl

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