Ovoca Bio PLC First Patient Enrolled in Phase II Study - BP-101 (2502N)

TIDMOVB

RNS Number : 2502N

Ovoca Bio PLC

29 January 2021

Ovoca Bio plc

("Ovoca" or the "Company")

Ovoca Bio Announces First Patient Enrolled in Phase II Dose Ranging Study Assessing

BP-101 for HSDD

Dublin, Ireland, 29 January 2021 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, today announces that the first patient has been enrolled in a Phase II dose ranging study assessing BP-101, a novel treatment for premenopausal women with hypoactive sexual desire disorder (HSDD), a condition characterized by a distressing lack or loss of sexual desire.

This Phase II dose ranging study is being conducted in Australia and New Zealand and will investigate BP-101 administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by participating patients. This double-blind placebo-controlled study is expected to enrol 476 patients across 13 sites. BP-101 is a synthetic peptide administered through a nasal spray and has been supplied for this study by well established peptide manufacturers in Switzerland and the UK.

The co-primary objectives of the study will be to evaluate the effect of three different doses of BP-101 and placebo, on (1) sexual desire, as measured by the Female Sexual Function Index (FSFI) desire domain; and, (2) the degree to which a participant is bothered by low sexual desire, as measured by the Female Sexual Distress Scale. The change in those clinically relevant and validated endpoints will be assessed between a four week baseline period and after four weeks of daily dosing. All study participants will be female and have a diagnosis of acquired, generalised HSDD.

More information about the Phase II study can be found through clicking on the following link: ACTRN12620001356954

Data from a Russian pivotal Phase III trial of BP-101, which was announced in March 2019, showed that the drug demonstrated a strong efficacy profile in patients with HSDD. Patients reported a significant increase in the number of satisfying sexual events when compared to a placebo controlled group, as well as a significant improvement in sexual desire and reduction of distress associated with low sexual desire. The current Phase II study will provide data in a Western population fully compliant with the standards of the International Conference on Harmonisation that, if successful in validating the results of the Russian studies and with completion of concurrent preclinical studies, will ultimately support a clinical programme in the US and EU.

Principal Investigator, Professor Susan Davis at the School of Public Health and Preventive Medicine, Monash University, said: "HSDD can have a profound impact on women's lives and has been identified by the US FDA as an area of high priority and significant unmet medical need. We welcome the opportunity to offer patients access to this study and are eager to gather further data to help assess the potential of BP-101 as a future treatment for this condition."

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said: "We are delighted that the first patient has been enrolled in this Phase II study as we continue towards our goal of establishing the value of BP-101 as a potential treatment for patients around the world suffering from HSDD. We hope that this study of BP-101, the first to be conducted outside of Russia, will pave the way for the international development of BP-101 in the US and EU. We look forward to providing further updates in due course."

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For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel [phone]

[e-mail]

Davy (Nominated Adviser, Euronext Growth Advisor and Broker)

John Frain / Daragh O'Reilly

Tel: [phone]

Consilium Strategic Communications

Chris Gardner, Chris Welsh, Carina Jurs

[e-mail]

Tel: [phone]

About hypoactive sexual desire disorder (HSDD)

HSDD is defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) as distressing and persistent deficiency of sexual fantasies and desire for sexual activity, thus having major effects on patients' ability to enjoy a fulfilling sex life. The Society for Women's Health Research, a non-profit organization in the US, estimates that about one in ten premenopausal women have HSDD, making it one of the most common female sexual problems.

About Ovoca Bio

Ovoca Bio is a European-based biopharmaceutical company with a focus on women's health. The Company is currently developing a novel treatment for women with hypoactive sexual desire disorder (HSDD).

The Company's lead product, BP-101, a novel synthetic peptide administered through a nasal spray, is clinically validated, with Phase II and Phase III studies conducted in Russia demonstrating statistically significant improvement in a number of key efficacy outcomes, including an increase in female sexual desire and reduction of symptoms of distress associated with HSDD.

Ovoca Bio is seeking to develop the drug for major global markets - in particular the United States and Europe, as well as obtain marketing approval in the Russian Federation.

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January 29, 2021 02:00 ET (07:00 GMT)