Ovoca Bio PLC Completion of Enrollment in Phase II Study (1440U)
29 Luglio 2022 - 8:00AM
UK Regulatory
TIDMOVB
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."
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 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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