Freya Pharma Solutions secures US$8.5 million enabling the start of a pivotal phase 3 trial with Lybrido against Female Sexual Interest/Arousal Disorder (FSIAD)

• Proceeds to be used for a phase 3 registration enabling trial with Lybrido
• Funding from existing and new investors, reflecting great confidence in the candidate to be evaluated
• FSIAD is a type of sexual dysfunction and a recognized unmet medical need with very limited effective treatment options

Amsterdam, March 29, 2022 - 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 to have secured US$8.5 million in new funding from existing and new investors. The new funding will be used to carry out a pivotal phase 3 trial with its therapy Lybrido in 516 patients across Europe. Previously, Lybrido showed clinical relevance and statistical significance in a phase 2b clinical trial, clearly meeting the primary endpoints. The phase 3 trial will start in the second half of 2022, with interim results expected by the second half of 2023.

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 female sexual interest/arousal disorder (FSIAD). Clinical research Organization CR2O BV (www.CR2O.nl) is leading the preparation, execution and reporting of this Phase 3 clinical trial. CR2O is a full-service clinical contract research organization aimed at developing innovative treatments for unmet medical needs.

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 trial design protocol, 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.

Marcel Wijma, Executive Director of Freya Pharma Solutions comments:

“We’re delighted with the trust and confidence from our existing and new shareholders in the chances of advancing this groundbreaking therapy for women with FSIAD to the market in due course. And we’re fully committed to bringing a therapy for FSIAD to a great number of patients around the world suffering from this distressing disorder.”

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 to investigate 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 about 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 inhibitor sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the phosphodiesterase type 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.