REG - Ovoca Bio PLC - Summary Results of Phase II Study for Orenetide

Ovoca BioAnnouncement

31/08/2023 07:00

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RNS Number : 8586K  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
(http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380376&isReview=true)

 

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.

 

End

 

For further information:

Ovoca Bio plc

Kirill Golovanov (Chief Executive)

Tel +353 1 661 9819

info@ovocabio.com (mailto:info@ovocabio.com)

 

Davy (Nominated Adviser, Euronext Growth Listing Sponsor and Broker)

Ivan Murphy / Daragh O'Reilly

Tel: +353 1 679 6363

 

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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