REG - Ovoca Bio PLC - Update on Completion Timelines for Phase II Study

Ovoca BioAnnouncement

12/06/2023 07:00

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RNS Number : 3213C  Ovoca Bio PLC  12 June 2023

Ovoca Bio plc

 

("Ovoca" or the "Company")

 

Ovoca Bio Provides Update on Completion Timelines for Phase II Dose Ranging
Study Assessing Orenetide for HSDD

Dublin, Ireland, 12 June 2023 - Ovoca Bio, a biopharmaceutical company with a
focus on women's health, today announces an update regarding the completion
timeline of its ongoing Phase II dose ranging study assessing Orenetide (the
"Study"), a novel treatment for women with hypoactive sexual desire disorder
("HSDD"), which is being conducted in Australia and New Zealand. The Company
has been informed by its retained Australian Contract Research Organisation
(CRO) that, due to issues with staffing levels at the CRO, the timeline for
delivery of the results of the Study has been delayed, with the results now
anticipated to be finalized in August as opposed to the previously anticipated
timeframe of June this year. While this is disappointing, the staffing issues
have now been resolved and Ovoca wishes to assure its stakeholders that every
effort is being made to expedite the completion and ensure the accuracy and
reliability of the results of the Study.

Dr. Daniil Nemenov, SVP for Clinical Development & Operations at Ovoca,
expressed the company's position regarding the delay, stating, "the team here
at Ovoca believe the results of this Study are of great significance to our
stakeholders, patients, and the broader medical community. Our team has been
working diligently with the CRO to address the challenges encountered, and we
remain committed to completing the Study in the most efficient and accurate
manner possible."

Ovoca would like to emphasize that this delay does not impact the overall
commitment and dedication towards advancing Orenetide research and delivering
therapeutic solution to patients. The Company's primary focus remains on
ensuring patient wellbeing, adhering to rigorous scientific approach, and
maintaining the highest standards of quality throughout the Study.

Ovoca will keep shareholders updated should there be any further developments
or changes in respect of the revised timeline and the Company looks forward to
sharing the results of the Study in due course.

 

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 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 (earlier - BP-101), a novel synthetic
peptide administered through a nasal spray, is clinically validated, with
earlier conducted regional Phase II and Phase III studies 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 is seeking to develop the drug for major global markets - in
particular the United States and Europe.

 

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