Report on the first meeting – contribution of the SAB to the pivotal phase 3 clinical trial protocol for Lybrido, to be finalized soon hereafter
AMSTERDAM, May 25, 2022 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced that on 30 April 2022 the first meeting of the newly installed Scientific Advisory Board (SAB) was held. The SAB, chaired by Freya's Chief Medical Officer Jan van der Mooren, consists of five independent recognized medical scientists, which together shape a highly important advisory body for the company. The SAB sees to it that the quality of research at Freya is maintained and will oversee and assess its upcoming pivotal phase 3 clinical trial protocol and execution with Lybrido.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated: "The members of the Scientific Advisory Board are leading experts in the specific field of female sexual disorders. We are delighted to have such a strong group of individuals join our Scientific Advisory Board, providing us with objective, external perspective and quality authentication. They are thought leaders within this specific scientific community."
During its first meeting on 30 April 2022, the SAB together with the Lybrido Clinical Project Team worked on drafting the protocol for the phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD. The protocol is expected to be ready for obtaining EMA Scientific Advice this summer.
Scientific Advisory Board
Members of the newly formed Scientific advisory Board are:
Prof. Annamaria Giraldi MD, PhD, FECSM
Professor Annamaria Giraldi is Senior Consultant in Psychiatry in the Sexological Clinic at Psychiatric Center Copenhagen and Professor of Clinical Sexology at the University of Copenhagen, Denmark, where she also received her medical degree and PhD. Professor Giraldi has been involved in the field of sexual medicine for many years, educating medical students, nurses, physicians and psychologists in sexual medicine.
Prof. Rossella Nappi MD, PhD
Professor Rossella Nappi is Full Professor of Obstetrics and Gynaecology, Research Center for Reproductive Medicine and Director of the Reproductive Medicine, Gynaecological Endocrinology & Menopause Unit, IRCCS San Matteo Foundation, University of Pavia, Italy. Professor Nappi's major interests are psycho-neuroendocrinology of female reproductive life and women's sexuality. She has published around 350 scientific articles in peer-reviewed journals and international books with more than 18,000 citations.
Prof. Cobi Reisman MD, PhD, FCESM,ECPS
Professor Cobi Reisman is urologist, sexologist, lecturer, honorary professor, and currently medical director of Flare-Health institute in Amstelveen, the Netherlands, senior lecturer of Clinical Sexology at the postgraduate institute RINO-Amsterdam, Consultant at Reuth Rehabilitation Hospital Tel-Aviv and co-director of the European Society for Sexual Medicine (ESSM) School of Sexual Medicine. He has more than 20 years of clinical experience focusing on sexual dysfunctions in males and females. In 1998 he received his PhD thesis on diagnostic tools and objective medical decisions. Editors of the ESSM manual of sexual medicine and EFS-ESSM Syllabus of clinical sexology, Cancer and sexuality and Textbook of rare sexual medicine conditions.
Prof. Linda Vignozzi MD, PhD, FECSM
Professor Linda Vignozzi is Associate Professor in Endocrinology at the University of Florence, Department of Experimental and Clinical Biomedical Sciences where she coordinates the Gynaecological Endocrinology Research Unit in the Sexual Medicine and Andrology Unit. Professor Vignozzi has written several book chapters and invited reviews in the field of male and female sexual medicine, hypogonadism and metabolic diseases, prostatic diseases, including BPH, and human reproduction.
Dr. Giovanni Corona MD, PhD, FCESM
Dr. Giovanni Corona is endocrinologist and andrologist at the Endocrinology Unit of Maggiore-Bologna Hospital, Bologna, Italy. He received an MD degree at the University of Bologna and a Board in Endocrinology and Doctor of Philosophy degree at the University of Florence. He received two prestigious awards, one in 2009 from the European Society for Sexual Medicine, "Excellent Award" and the second in 2013 from the International Society of Andrology, the "Young Andrologist Award". In 2015 he was quoted in the top best European 30 researchers (category "Reproductive Biomedicine" n=11) by Lab Times. He is co-author of over 250 peer-reviewed papers, different book chapters and invited reviews in the field of endocrinology and sexual medicine.
Dr. Jan van der Mooren MD, PhD, MSc, is Chairman of the SAB and Chief Medical Officer of Freya Pharma Solutions.
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.
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
LifeSpring Life Sciences Communication, Amsterdam
T: +31 6 538 16 427
SOURCE Freya Pharma Solutions