Month: February 2023

Amsterdam, the Netherlands, 22 February 2023 – 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 Lybrido^TM.

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 Lybrido^TM 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 Lybrido^TM 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 Lybrido^TM 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 Lybrido^TM, 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 Lybrido^TM 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 Lybrido^TM 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.

Please contact for further information:

Freya Pharma Solutions, Amsterdam

Marcel Wijma, Chief Executive Officer

E: marcel@freyapharmasolutions.com

For media

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

T: +31 6 538 16 427

E: lmelens@lifespring.nl

Dr. Irwin Goldstein, Sue Goldstein, Prof. Sheryl Kingsberg, and Dr. Rachel Rubin

Amsterdam, the Netherlands, 10 February 2023 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), today announced the extension of its Scientific Advisory Board (SAB) with four independent leading medical scientists in the FSD field from the US: Dr. Irwin Goldstein, Sue Goldstein, Prof. Sheryl Kingsberg, and Dr. Rachel Rubin. The extension was established in the light of the start of preparations for Freya’s clinical development program for Lybrido^TM against Female Sexual Disorders in the United States. The first meeting with the new members took place on 4 February 2023 in Houston, US. The SAB is chaired by Freya’s Chief Medical Officer Dr. Jan van der Mooren.

In 2022 Freya announced the initiation of its SAB with experts from Europe: Prof. Annamaria Giraldi, Prof. Rossella Nappi, Prof. Cobi Reisman, Prof. Linda Vignozzi and Dr. Giovanni Corona, to design the European clinical program. The US members have been installed to further shape this highly important advisory body for the company. The SAB co-designs the clinical program for Lybrido^TM overseeing that the quality of research at Freya is maintained, as well as assessing its upcoming confirmatory clinical trials with Lybrido^TM.

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 wellbeing. 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.

About Lybrido^TM

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^TM) and women with dysfunctional over-activation of sexual inhibition (Lybridos^TM). Lybrido^TM 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^TM and Lybridos^TM, 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.

Please contact for further information:

Freya Pharma Solutions, Amsterdam

Marcel Wijma, Executive Director

E: marcel@freyapharmasolutions.com

For media

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

T: +31 6 538 16 427

E: lmelens@lifespring.nl

Amsterdam, the Netherlands, 1 February 2023 – 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 Nicole Hijnen, PhD (picture below) as President of Freya’s Board as per January 2023. Dr. Hijnen is a health scientist who held a variety of senior management positions within Philips Healthtech, most recently as Director – Business Leader Connected Care Benelux. Her appointment comes in a year where Freya is rolling out its final clinical development program, starting with the confirmatory ALETTA clinical trial with Lybrido^TM in premenopausal women with acquired FSIAD.

Marcel Wijma, CEO at Freya Pharma Solutions said:

“We are very pleased to have Nicole join Freya as President of our Board as we are on the brink of commencing our confirmatory clinical trial with our promising compound Lybrido^TM against FSIAD. She brings exactly the right blend of academic and operational healthtech experience to help guide Freya to the next phase. With her deep knowledge of evolving FemTech science and technology, as well as her views on galvanizing an impassioned patient community, Nicole possesses all the skills to help propel our vision – addressing the urgent unmet medical need of women worldwide suffering from FSIAD.”

In addition to bringing a wealth of experience from the healthtech industry at Philips, Dr. Hijnen has held a number of senior management and scientific positions worldwide. She obtained vast commercialization experience in the medical device industry and has a deep understanding of the EU and US markets. Within Philips she brought new medical devices to the US market among others, being responsible for end-to-end design, FDA approval, and sales, including claim strategy and setup of sales channels.

Dr. Hijnen obtained her MSc in Biomedical Engineering at TU – Eindhoven and her PhD in magnetic resonance-guided high intensity focused ultrasound for non-invasive thermal cancer therapy at TU – Eindhoven and Philips. Currently, she is a non-executive board member of the medical company SyncVR Medical. She is also an active investor in food and healthcare companies and participates in Arches Capital in Amsterdam, a group of business angels bridging the gap between Venture Capital companies (VCs) and business angels by connecting knowledge with capital.

Nicole Hijnen, PhD, new President of Freya’s Board, commented:

“I am excited to be joining Freya as President of the Board. I look forward to working with Freya’s excellent leadership team. Our goal is to empower women worldwide to own their sexual health, which is fundamental to the overall health and well-being of individuals, couples and families. The scientific progress is there – women may enjoy its benefits! Freya has a strong, intelligent concept with a formulation of two compounds that have been shown to be safe and effective in a compelling clinical phase 2 trial, successfully improving sexual desire and arousal. I see great potential and look forward to really making a difference by overseeing the preparations for and execution of the decisive confirmatory ALETTA trial with Lybrido^TM.”

Freya Pharma Solutions is currently preparing the clinical development program with several studies with Lybrido^TM 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 Lybrido^TM 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 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-V 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. Women 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^TM) and women with dysfunctional over-activation of sexual inhibition (Lybridos^TM). Lybrido^TM intends to increase central sexual motivation and physiological sexual responses. The therapy can be taken ‘on demand’ and helps to increase sexual desire and arousal from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet containing a testosterone coating for sublingual administration and an inner-core component made of 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 testosterone. 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.