Freya Pharma Solutions Receives Early EMA Scientific Advice on its upcoming Phase 3 Clinical Trial to Confirm Efficacy of Lybrido in Women Suffering From FSIAD

AMSTERDAM, Sept. 28, 2022 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the receipt of early European Medicines Agency (EMA) scientific advice on its upcoming pivotal phase 3 clinical trial (the ALETTA trial), investigating Lybrido for the treatment of FSIAD. The EMA Committee for Medicinal Products for Human Use (CHMP) came to its conclusions within the short, 40-day evaluation phase, without necessitating a discussion meeting for further clarification. Freya will now implement the adjustments as recommended by EMA in its clinical development program for Lybrido.

Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:

"I am very happy with this early EMA scientific advice, as it represents an important milestone in the development program for Lybrido. The EMA advice holds very constructive and valuable elements that will contribute to the successful development of our therapy. It also strengthens our understanding of how to further design the clinical program to ensure a timely launch of Lybrido on the European market. Following the short procedure, Freya is still well on track with its planning of the ALETTA trial. Lybrido is an innovative drug in a market with very few approved drugs in the United States, and no drug being approved in Europe so far."

Together with the expert support of the members of the Scientific Advisory Board, Freya will implement the adjustments as recommended by the EMA in the clinical development program of Lybrido. The initial focus will be on the study protocol of the ALETTA trial, a randomized placebo-controlled phase 3 clinical trial to demonstrate the efficacy and safety of Lybrido. Clinical research organization CR2O BV (www.CR2O.nl) is leading the preparation, execution, and reporting of this trial.

Freya Pharma Solutions is currently preparing the first phase 3 clinical trial in Europe as part of a clinical development program with several studies in Europe, to be followed later by additional trials in the United States. The company is highly confident that it is well on track with the clinical development of Lybrido as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively interferes with their quality of life.

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 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 safety and efficacy 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 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 is being developed as 'on demand' treatment with the aim to increase central sexual motivation from 3 to 6 hours after intake. This treatment comprises 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 sildenafil coincides with the window of increased sexual motivation induced by the testosterone component. 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. www.freyapharmasolutions.com

Please contact for further information:

Freya Pharma Solutions, Amsterdam

Marcel Wijma, Chief Executive Officer 
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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