Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that participants of the European Society for Sexual Medicine (ESSM) Congress, held 16 – 18 February, 2023, in Rotterdam, The Netherlands, showed great interest in Freya’s innovative drug candidate LybridoTM.
The ESSM congress was attended by around 700 participants from 59 countries around the world representing a broad range of sexual health practitioners. The design for the confirmatory ALETTA clinical trial was presented by Professor Cobi Reisman, member of Freya’s Scientific Advisory Board and urologist, sexologist, lecturer, honorary professor, and currently medical director of Flare-Health institute in Amstelveen, the Netherlands.
Furthermore, during a very well attended round table discussion entitled “Hypoactive Sexual Desire in young women: What women want” conversations took place among key experts in the field. Professor Linda Vignozzi, Professor Annamaria Giraldi, Dr. Shelly Varod, Dr. Giovani Corona, and Professor Cobi Reisman referred to LybridoTM as a promising innovative treatment for women suffering from FSD. From the many questions and discussions that followed the experts’ presentations, it can be concluded that there is a high unmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe, and that LybridoTM is expected to address such a need.
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:
“I was delighted to experience such positive feedback on LybridoTM from so many sexual health experts and practitioners. Even though we must await the results of the upcoming clinical trials in Europe and the United States before women will have access to LybridoTM, the results from the phase 2 clinical trials have already been very promising, showing positive efficacy results without indications for safety concerns. The ALETTA Confirmatory Clinical Study is planned to start soon in Europe, and we hope to receive advice from the FDA on our Clinical Development Plan for the United States in spring this year.”
Freya Pharma Solutions is currently preparing the clinical development program of LybridoTM with several studies in Europe, to be followed later by additional trials in the United States. In September 2022, Freya received early scientific advice from the European Medicines Agency (EMA) on its upcoming confirmatory ALETTA clinical trial, providing constructive and valuable elements that will contribute to the successful development of the therapy. The company is highly confident that it is well on track with the clinical development of LybridoTM as a treatment for women suffering from sexual dysfunction and the related distress which often negatively interferes with their quality of life and their relationships.
About Female Sexual Disorders
Among female sexual disorders, 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 well-being. Currently, several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is recommended by ISSWSH and is a sexual dysfunction in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress. Female Sexual Interest/Arousal Disorder (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.
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 genitals 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-immediate-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 sublingually administered 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 HSDD/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 HSDD/FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
For further information please contact:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
LifeSpring Life Sciences Communication, Amsterdam Leon Melens
T: +31 6 538 16 427
E: [email protected]