Ovoca Bio PLC Summary Results of Phase II Study for Orenetide (8586K)
31 8월 2023 - 3:00PM
UK Regulatory
TIDMOVB
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
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 EUR2.6 million.
End
For further information:
Ovoca Bio plc
Kirill Golovanov (Chief Executive)
Tel +353 1 661 9819
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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