Completion of Enrollment in Phase II Study

RNS Number : 1440U

Ovoca Bio PLC

29 July 2022

 

Ovoca Bio plc

("Ovoca" or the "Company")

Ovoca Bio Announces Completion of Enrollment in Phase II Dose Ranging Study Assessing Orenetide for HSDD

Dublin, Ireland, 29 July 2022 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, today announces the successful completion of the enrollment of participants in a Phase II dose ranging study assessing Orenetide (the "Study"), a novel treatment for premenopausal women with hypoactive sexual desire disorder ("HSDD"). HSDD is a condition characterized by a distressing lack or loss of sexual desire. Despite a challenging global environment due to COVID-19 restrictions, the company is pleased to have successfully completed the enrollment in accordance with the previously announced timeline and schedule.

This Phase II dose ranging Study is being conducted in Australia and New Zealand in order to investigate Orenetide administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by Study participants. 667 women have been screened in this double-blind placebo-controlled Study to allow up to 462 participants to be treated across 13 sites. The Ovoca management team currently expects that all enrolled participants will complete the Study in the next four months, which will allow the assessment of study results in Q1 2023.

The co-primary objectives of the Study are to evaluate the effect of three different doses of Orenetide 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 are female and have a diagnosis of acquired, generalised HSDD. Orenetide 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.

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

Data generated from previous clinical trials led to Marketing Authorization being granted to Ovoca's subsidiary Ivix Ltd. by the Russian Ministry of Health of Orenetide (under trade name of "Desirix") for treatment of HSDD in Russia earlier in February 2022. 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 a preclinical programme, will ultimately support further clinical development in the US, EU, and internationally.

Dr. Daniil Nemenov, SVP for Clinical Development and Operations of Ovoca Bio plc, said: "We are pleased to announce the completion of the recruitment of participants in this important study. Despite the challenges encountered during this recruitment journey, including significant COVID-related restriction in Australia and New Zealand, we saw significant enthusiasm and willingness to participate in our study among the target patient population - women with distressing problems with their libido. This once again confirms that we are working in a field of significant unmet medical need, where Orenetide may be a sought-after product."

Kirill Golovanov, Chief Executive Officer of Ovoca Bio plc, said:  "We are delighted that all participants have been enrolled in this Phase II study as we continue towards our goal of establishing the value of Orenetide as a potential treatment for HSDD around the world. We hope that this clinical study will pave the way for the development of Orenetide in wider international markets, including 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 Listing Sponsor and Broker)

Ivan Murphy / Daragh O'Reilly

Tel: [phone]

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), a condition characterized by a distressing lack or loss of sexual desire affecting an estimated ~4 million premenopausal women in the US alone.

The Company's lead product, Orenetide (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 has been granted marketing approval in the Russian Federation and is seeking to develop the drug for major global markets - in particular the United States and Europe.

 

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