Summary Results of Phase II Study for Orenetide

Ovoca Bio PLC

31 August 2023

 

Ovoca Bio PLC

31 August 2023

This announcement contains inside information

Ovoca Bio plc

("Ovoca" or the "Company")

Ovoca Bio Announces Summary Results of Phase II Dose Ranging Study Assessing Orenetide for HSDD

Dublin, Ireland, 31 August 2023 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, announces a summary conclusion of the top-line results from its Phase II dose ranging study assessing Orenetide conducted in Australia and New Zealand (the "Study").

Study Results Summary

The Study did not show statistically significant superiority of Orenetide versus placebo on the co-primary endpoints of (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 (FSDS-DAO). Other secondary efficacy endpoints were also shown not to have statistically significant difference vs. placebo. The safety profile of the Orenetide observed in the Study was consistent with its previously known safety profile, and no new safety signals were identified.

Dr. Daniil Nemenov, SVP for Clinical Development and Operations of Ovoca Bio plc, said: "We are surprised and disappointed that the Study did not have a positive conclusion regarding the superiority of Orenetide versus placebo. The Company now intends to analyse the results from the Study in further detail, including investigating the reasons for potential differences between the Study results and results from previously conducted clinical trials of Orenetide. While we are naturally disappointed with these results, I would like thank all those involved in the Study to date, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Ovoca employees."

Study Process

The Phase II dose ranging study was conducted in Australia and New Zealand throughout 2021 and 2022 in order to evaluate the effect of a range of daily administered Orenetide doses on a lack or loss of sexual desire experienced by Study participants prior to the Study. In total, 667 women were screened in the double-blind placebo-controlled Study, with a final 453 participants were randomized and started treatment across 13 sites. Of them, 425 participants have completed treatment with Orenetide or placebo, and 390 participants have completed the whole Study.

The co-primary objectives of the Study were 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. All study participants were female and had 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 Study can be found through clicking on the following link ACTRN12620001356954

Summary

Following receipt of the Study results, Ovoca will complete a detailed investigation of the Study datasets and, based on the findings from these further investigations, will determine the appropriate future strategy regarding the development of Orenetide, including whether the Company should continue with its development of the product, and any implications this may have for the wider strategy of the Company. Further announcements will be made as and when appropriate. As at 31 July 2023, Ovoca has an unaudited cash balance of €2.6 million.

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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 Orenetide (BP-101), a novel synthetic peptide administered through a nasal spray as 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.

 

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